Generated Narrative: Composition compositionusen Language: en Profile: Composition (ePI) org/fhir/dummyValidationReference: UUID-IBRANCE-05 org/fhir/dummyValidationReference: UUID-IBRANCE-06 org/fhir/dummyValidationReference: UUID-IBRANCE-07 org/fhir/dummyValidationReference: UUID-IBRANCE-08 org/fhir/dummyValidationReference: UUID-IBRANCE-09 org/fhir/dummyValidationReference: UUID-IBRANCE-10 org/fhir/dummyValidationReference: UUID-IBRANCE-11 org/fhir/dummyValidationReference: UUID-IBRANCE-12 org/fhir/dummyValidationReference: UUID-IBRANCE-13 identifier: https://www.fda.gov//0d69fdcb-33cf-407f-8209-a6529856ab4f status: Final type: HUMAN PRESCRIPTION LABEL date: 2023-09-08 00:00:00+0000 author: Organization Pfizer Laboratories Div Pfizer Inc title: Ibrance (palbociclib) tablets - THIS DOCUMENT IS FOR TESTING PURPOSES ONLY. Generated Narrative: Binary #UUID-IBRANCE-05 contentType: image/jpeg data: (base64 data - 16,641 base64 chars) Generated Narrative: Binary #UUID-IBRANCE-06 contentType: image/jpeg data: (base64 data - 16,640 base64 chars) Generated Narrative: Binary #UUID-IBRANCE-07 contentType: image/jpeg data: (base64 data - 133,000 base64 chars) Generated Narrative: Binary #UUID-IBRANCE-08 contentType: image/jpeg data: (base64 data - 180,920 base64 chars) Generated Narrative: Binary #UUID-IBRANCE-09 contentType: image/jpeg data: (base64 data - 469,792 base64 chars) Generated Narrative: Binary #UUID-IBRANCE-10 contentType: image/jpeg data: (base64 data - 190,380 base64 chars) Generated Narrative: Binary #UUID-IBRANCE-11 contentType: image/jpeg data: (base64 data - 480,396 base64 chars) Generated Narrative: Binary #UUID-IBRANCE-12 contentType: image/jpeg data: (base64 data - 193,084 base64 chars) Generated Narrative: Binary #UUID-IBRANCE-13 contentType: image/jpeg data: (base64 data - 478,512 base64 chars)
Ibrance (palbociclib) tablets - THIS DOCUMENT IS FOR TESTING PURPOSES ONLY.
IBRANCE ® (EYE-brans) (palbociclib) Tablets
What is the most important information I should know about IBRANCE?
IBRANCE may cause serious side effects, including: Low white blood cell counts (neutropenia). Low white blood cell counts are very common when taking IBRANCE and may cause serious infections that can lead to death. Your healthcare provider should check your white blood cell counts before and during treatment. If you develop low white blood cell counts during treatment with IBRANCE, your healthcare provider may stop your treatment, decrease your dose, or may tell you to wait to begin your treatment cycle. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills. Lung problems (pneumonitis). IBRANCE may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms, including: chest pain cough with or without mucus trouble breathing or shortness of breath Your healthcare provider may interrupt or stop treatment with IBRANCE completely if your symptoms are severe. See "What are the possible side effects of IBRANCE?" for more information about side effects.
IBRANCE is a prescription medicine used in adults to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic) in combination with: an aromatase inhibitor as the first hormonal based therapy in postmenopausal women or in men, or fulvestrant in people with disease progression following hormonal therapy. It is not known if IBRANCE is safe and effective in children.
Before taking IBRANCE, tell your healthcare provider about all of your medical conditions, including if you:
have fever, chills, or any other signs or symptoms of infection. have liver or kidney problems. are pregnant, or plan to become pregnant. IBRANCE can harm your unborn baby. Females who are able to become pregnant should use effective birth control during treatment and for at least 3 weeks after the last dose of IBRANCE. Your healthcare provider may ask you to take a pregnancy test before you start treatment with IBRANCE. Males with female partners who can become pregnant should use effective birth control during treatment with IBRANCE for at least 3 months after the last dose of IBRANCE. Talk to your healthcare provider about birth control methods that may be right for you during this time. If you become pregnant or think you are pregnant, tell your healthcare provider right away. are breastfeeding or plan to breastfeed. It is not known if IBRANCE passes into your breast milk. Do not breastfeed during treatment with IBRANCE and for 3 weeks after the last dose. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. IBRANCE and other medicines may affect each other causing side effects.
Take IBRANCE exactly as your healthcare provider tells you. IBRANCE tablets may be taken with or without food. IBRANCE should be taken at about the same time each day. Swallow IBRANCE tablets whole. Do not chew, crush or split IBRANCE tablets before swallowing them. Do not take any IBRANCE tablets that are broken, cracked, or that look damaged. Avoid grapefruit and grapefruit products during treatment with IBRANCE. Grapefruit may increase the amount of IBRANCE in your blood. Do not change your dose or stop taking IBRANCE unless your healthcare provider tells you. If you miss a dose of IBRANCE or vomit after taking a dose of IBRANCE, do not take another dose on that day. Take your next dose at your regular time. If you take too much IBRANCE, call your healthcare provider right away or go to the nearest hospital emergency room.
What are the possible side effects of IBRANCE?
IBRANCE may cause serious side effects. See "What is the most important information I should know about IBRANCE?" The most common side effects of IBRANCE when used with either letrozole or fulvestrant include: Low red blood cell counts and low platelet counts are common with IBRANCE. Call your healthcare provider right away if you develop any of these symptoms during treatment: dizziness shortness of breath weakness bleeding or bruising more easily nosebleeds infections (see "What is the most important information I should know about IBRANCE? ") tiredness nausea sore mouth abnormalities in liver blood tests diarrhea hair thinning or hair loss vomiting rash loss of appetite IBRANCE may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider about family planning options before starting IBRANCE if this is a concern for you. These are not all of the possible side effects of IBRANCE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Store IBRANCE at 68 °F to 77 °F (20 °C to 25 °C) in the original blister pack. Keep IBRANCE and all medicines out of the reach of children.
General information about the safe and effective use of IBRANCE
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IBRANCE for a condition for which it was not prescribed. Do not give IBRANCE to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for more information about IBRANCE that is written for health professionals.
Active ingredient: palbociclib Inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, succinic acid, HPMC 2910/hypromellose, titanium dioxide, triacetin, and FD&C Blue #2/Indigo Carmine Aluminum Lake. In addition, the 75 mg and 125 mg tablets contain red iron oxide and the 100 mg tablets contain yellow iron oxide. LAB-1372-1.0 For more information, go to www.IBRANCE.com or call 1-800-438-1985.
Your Monthly Box Includes 3 weekly packs of IBRANCE® (palbociclib) medication. Fill in the dates below to help track your treatment cycle. Treatment Cycle Week 1 Week 2 Week 3 IBRANCE Week 4 No IBRANCE My Treatment Cycle Tracker I start my Week 1 treatment cycle on: ________ / ______ MONTH DAY After Week 4, I will start my next treatment cycle on: ________ / ______ MONTH DAY PAA119239
PRINCIPAL DISPLAY PANEL - 75 MG TABLET DOSE PACK
Pfizer NDC 0069-0284-07 IBRANCE® (palbociclib) tablets 75 mg per tablet This weekly pack contains: 7 tablets Rx only
PRINCIPAL DISPLAY PANEL - 75 MG TABLET DOSE PACK CARTON
Pfizer NDC 0069-0284-03 IBRANCE® (palbociclib) tablets 75 mg 21 tablets Monthly Box Contains: 3 individual weekly packs. Each pack contains 7 IBRANCE tablets (75 mg per tablet). Rx only Safety Label
PRINCIPAL DISPLAY PANEL - 100 MG TABLET DOSE PACK
Pfizer NDC 0069-0486-07 IBRANCE® (palbociclib) tablets 100 mg per tablet This weekly pack contains: 7 tablets Rx only
PRINCIPAL DISPLAY PANEL - 100 MG TABLET DOSE PACK CARTON
Pfizer NDC 0069-0486-03 IBRANCE® (palbociclib) tablets 100 mg 21 tablets Monthly Box Contains: 3 individual weekly packs. Each pack contains 7 IBRANCE tablets (100 mg per tablet). Rx only Safety Label
PRINCIPAL DISPLAY PANEL - 125 MG TABLET DOSE PACK
Pfizer NDC 0069-0688-07 IBRANCE® (palbociclib) tablets 125 mg per tablet This weekly pack contains: 7 tablets Rx only
PRINCIPAL DISPLAY PANEL - 125 MG TABLET DOSE PACK CARTON
Pfizer NDC 0069-0688-03 IBRANCE® (palbociclib) tablets 125 mg 21 tablets Monthly Box Contains: 3 individual weekly packs. Each pack contains 7 IBRANCE tablets (125 mg per tablet). Rx only Safety Label
Generated Narrative: Organization ORG1 Profile: Organization (ePI) identifier: urn:oid:1.3.6.1.4.1.519.1/134489525 active: true type: Non-Healthcare Business or Corporation name: Pfizer Laboratories Div Pfizer Inc
Generated Narrative: Organization ORG2 Profile: Organization (ePI) identifier: urn:oid:1.3.6.1.4.1.519.1/985052076 active: true type: Non-Healthcare Business or Corporation name: Pfizer Ireland Pharmaceuticals
Generated Narrative: Organization ORG3 Profile: Organization (ePI) identifier: urn:oid:1.3.6.1.4.1.519.1/341970073 active: true type: Non-Healthcare Business or Corporation name: Pfizer Manufacturing Deutschland GmbH
Generated Narrative: Organization ORG4 Profile: Organization (ePI) identifier: urn:oid:1.3.6.1.4.1.519.1/936889401 active: true type: Non-Healthcare Business or Corporation name: Pfizer Asia Manufacturing Pte Ltd
Generated Narrative: Organization ORG5 Profile: Organization (ePI) identifier: urn:oid:1.3.6.1.4.1.519.1/999999999999999 active: true type: Government name: Food and Drug Administration
Generated Narrative: Ingredient UUID-CROSPOVIDONE Profile: Ingredient (ePI) identifier: <a href="http://terminology.hl7.org/6.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)/2S7830E561 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit role: inactive ingredient allergenicIndicator: true substance Codes - Concept * CROSPOVIDONE
Generated Narrative: Ingredient UUID-FDCBLUE2 Profile: Ingredient (ePI) identifier: <a href="http://terminology.hl7.org/6.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)/L06K8R7DQK (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit role: Inactive allergenicIndicator: false substance Codes - Concept * FD&C BLUE NO. 2
Generated Narrative: Ingredient UUID-FERRIC-OXIDE-RED Profile: Ingredient (ePI) identifier: <a href="http://terminology.hl7.org/6.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)/1K09F3G675 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit role: Inactive allergenicIndicator: false substance Codes - Concept * FERRIC OXIDE RED
Generated Narrative: Ingredient UUID-FERRIC-OXIDE-YELLOW Profile: Ingredient (ePI) identifier: <a href="http://terminology.hl7.org/6.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)/EX438O2MRT (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit role: Inactive allergenicIndicator: false substance Codes - Concept * FERRIC OXIDE YELLOW
Generated Narrative: Ingredient UUID-HYPROMELLOSE Profile: Ingredient (ePI) identifier: <a href="http://terminology.hl7.org/6.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)/0WZ8WG20P6 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit role: Inactive allergenicIndicator: false substance Codes - Concept * HYPROMELLOSE 2910 (6 MPA.S)
Generated Narrative: Ingredient UUID-MAGNESIUM-STEARATE Profile: Ingredient (ePI) identifier: <a href="http://terminology.hl7.org/6.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)/70097M6I30 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit role: inactive ingredient allergenicIndicator: false substance Codes - Concept * MAGNESIUM STEARATE
Generated Narrative: Ingredient UUID-MICROCRYSTALLINE-CELLULOSE Profile: Ingredient (ePI) identifier: <a href="http://terminology.hl7.org/6.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)/OP1R32D61U (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit role: Inactive allergenicIndicator: false substance Codes - Concept * MICROCRYSTALLINE CELLULOSE
Generated Narrative: Ingredient palbociclib75 Profile: Ingredient (ePI) identifier: <a href="http://terminology.hl7.org/6.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)/G9ZF61LE7G (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit role: Active group: Kinase Inhibitor allergenicIndicator: false comment: PALBOCICLIB 75mg substance Codes - Concept * G9ZF61LE7G Strengths - Presentation[x] * 75 mg/1 1
Generated Narrative: Ingredient UUID-PALBOCICLIB100 Profile: Ingredient (ePI) identifier: <a href="http://terminology.hl7.org/6.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)/G9ZF61LE7G (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit role: Active group: Kinase Inhibitor allergenicIndicator: false comment: PALBOCICLIB 100mg substance Codes - Concept * G9ZF61LE7G Strengths - Presentation[x] * 100 mg/1 1
Generated Narrative: Ingredient UUID-PALBOCICLIB125 Profile: Ingredient (ePI) identifier: <a href="http://terminology.hl7.org/6.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)/G9ZF61LE7G (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit role: Active group: Kinase Inhibitor allergenicIndicator: false comment: PALBOCICLIB 125mg substance Codes - Concept * G9ZF61LE7G Strengths - Presentation[x] * 125 mg/1 1
Generated Narrative: Ingredient UUID-SILICON-DIOXIDE Profile: Ingredient (ePI) identifier: <a href="http://terminology.hl7.org/6.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)/ETJ7Z6XBU4 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit role: Inactive allergenicIndicator: false substance Codes - Concept * SILICON DIOXIDE
Generated Narrative: Ingredient UUID-SUCCINIC-ACID Profile: Ingredient (ePI) identifier: <a href="http://terminology.hl7.org/6.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)/AB6MNQ6J6L (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit role: Inactive allergenicIndicator: false substance Codes - Concept * SUCCINIC ACID
Generated Narrative: Ingredient UUID-TITANIUM-DIOXIDE Profile: Ingredient (ePI) identifier: <a href="http://terminology.hl7.org/6.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)/15FIX9V2JP (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit role: Inactive allergenicIndicator: false substance Codes - Concept * 15FIX9V2JP
Generated Narrative: Ingredient UUID-TRIACETIN Profile: Ingredient (ePI) identifier: <a href="http://terminology.hl7.org/6.5.0/NamingSystem-UNII.html" title="A UNII is a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. UNII identifiers are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication.">Unique Ingredient Identifier (UNII)/XHX3C3X673 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit role: Inactive allergenicIndicator: false substance Codes - Concept * TRIACETIN
Generated Narrative: ManufacturedItemDefinition UUID-MID-PALBOCICLIB75 Profile: ManufacturedItemDefinition (ePI) identifier: National drug codes/0069-0284 (use: official, ) status: Active manufacturedDoseForm: TABLET, FILM COATED unitOfPresentation: TABLET manufacturer: Organization Pfizer Ireland Pharmaceuticals Organization Pfizer Manufacturing Deutschland GmbH Organization Pfizer Asia Manufacturing Pte Ltd property type: COLOR value: PURPLE property type: SHAPE value: ROUND property type: SIZE value: 10 millimeter (Details: unitsofmeasure.org codemm = 'mm') property type: SPLIMPRINT value: Pfizer;PBC;75
Generated Narrative: ManufacturedItemDefinition UUID-MID-PALBOCICLIB100 Profile: ManufacturedItemDefinition (ePI) identifier: National drug codes/0069-0486 (use: official, ) status: Active manufacturedDoseForm: TABLET, FILM COATED unitOfPresentation: TABLET manufacturer: Organization Pfizer Ireland Pharmaceuticals Organization Pfizer Manufacturing Deutschland GmbH Organization Pfizer Asia Manufacturing Pte Ltd property type: COLOR value: GREEN property type: SHAPE value: OVAL property type: SIZE value: 15 millimeter (Details: unitsofmeasure.org codemm = 'mm') property type: SPLIMPRINT value: Pfizer;PBC;100
Generated Narrative: ManufacturedItemDefinition UUID-MID-PALBOCICLIB125 Profile: ManufacturedItemDefinition (ePI) identifier: National drug codes/0069-0688 (use: official, ) status: Active manufacturedDoseForm: TABLET, FILM COATED unitOfPresentation: TABLET manufacturer: Organization Pfizer Ireland Pharmaceuticals Organization Pfizer Manufacturing Deutschland GmbH Organization Pfizer Asia Manufacturing Pte Ltd property type: COLOR value: PURPLE property type: SHAPE value: OVAL property type: SIZE value: 16 millimeter (Details: unitsofmeasure.org codemm = 'mm') property type: SPLIMPRINT value: Pfizer;PBC;125
Generated Narrative: MedicinalProductDefinition UUID-MPD-PALBOCICLIB75 Profile: MedicinalProductDefinition (ePI) identifier: National drug codes/0069-0284 (use: official, ) type: Approved for Human Use Product domain: Human version: 1 status: Active statusDate: 2020-03-30 00:00:00+0000 combinedPharmaceuticalDoseForm: TABLET, FILM COATED legalStatusOfSupply: Marketing Authorization classification: Kinase Inhibitor [EPC] MarketingStatuses - Status * Marketing Contacts - Contact * Organization Pfizer Laboratories Div Pfizer Inc name productName: IBRANCE® (palbociclib) tablets - 75 mg type: Proprietary Name Usages - Country Jurisdiction Language * United States of America United States of America English
Generated Narrative: MedicinalProductDefinition UUID-MPD-PALBOCICLIB100 Profile: MedicinalProductDefinition (ePI) identifier: National drug codes/0069-0486 (use: official, ) type: Approved for Human Use Product domain: Human version: 1 status: Active statusDate: 2020-03-30 00:00:00+0000 combinedPharmaceuticalDoseForm: TABLET, FILM COATED legalStatusOfSupply: Marketing Authorization classification: Kinase Inhibitor [EPC] MarketingStatuses - Status * Marketing Contacts - Contact * Organization Pfizer Laboratories Div Pfizer Inc name productName: IBRANCE® (palbociclib) tablets - 100 mg type: Proprietary Name Usages - Country Jurisdiction Language * United States of America United States of America English
Generated Narrative: MedicinalProductDefinition UUID-MPD-PALBOCICLIB125 Profile: MedicinalProductDefinition (ePI) identifier: National drug codes/0069-0688 (use: official, ) type: Approved for Human Use Product domain: Human version: 1 status: Active statusDate: 2020-03-30 00:00:00+0000 combinedPharmaceuticalDoseForm: TABLET, FILM COATED legalStatusOfSupply: Marketing Authorization classification: Kinase Inhibitor [EPC] MarketingStatuses - Status * Marketing Contacts - Contact * Organization Pfizer Laboratories Div Pfizer Inc name productName: IBRANCE® (palbociclib) tablets - 125 mg type: Proprietary Name Usages - Country Jurisdiction Language * United States of America United States of America English
Generated Narrative: AdministrableProductDefinition UUID-APD-PALBOCICLIB75 Profile: AdministrableProductDefinition (ePI) identifier: National drug codes/0069-0284 (use: official, ) status: Active formOf: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] administrableDoseForm: Film Coated Tablet Dosage Form unitOfPresentation: Tablet Dosing Unit producedFrom: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit property type: Structured Product Labeling Color value: Purple property type: Structured Product Labeling Shape value: Round property type: SPLSIZE value: 10 millimeter (Details: unitsofmeasure.org codemm = 'mm') property type: SPLIMPRINT value: Pfizer;PBC;75 routeOfAdministration code: ORAL TargetSpecies - Code * HUMAN
Generated Narrative: AdministrableProductDefinition UUID-APD-PALBOCICLIB100 Profile: AdministrableProductDefinition (ePI) identifier: National drug codes/0069-0486 (use: official, ) status: Active formOf: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] administrableDoseForm: Film Coated Tablet Dosage Form unitOfPresentation: Tablet Dosing Unit producedFrom: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit property type: Structured Product Labeling Color value: Green property type: Structured Product Labeling Shape value: Oval property type: SIZE value: 15 millimeter (Details: unitsofmeasure.org codemm = 'mm') property type: SPLIMPRINT value: Pfizer;PBC;100 routeOfAdministration code: ORAL TargetSpecies - Code * HUMAN
Generated Narrative: AdministrableProductDefinition UUID-APD-PALBOCICLIB125 Profile: AdministrableProductDefinition (ePI) identifier: National drug codes/0069-0688 (use: official, ) status: Active formOf: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] administrableDoseForm: Film Coated Tablet Dosage Form unitOfPresentation: Tablet Dosing Unit producedFrom: ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit property type: Structured Product Labeling Color value: Purple property type: Structured Product Labeling Shape value: Oval property type: SIZE value: 16 millimeter (Details: unitsofmeasure.org codemm = 'mm') property type: SPLIMPRINT value: Pfizer;PBC;125 routeOfAdministration code: Oral Route of Administration TargetSpecies - Code * Human
Generated Narrative: PackagedProductDefinition UUID-PPD-PALBOCICLIB75-TAB-MONTH Profile: PackagedProductDefinition (ePI) identifier: National drug codes/NDC:0069-0284-03 (use: official, ) name: 75 MG TABLET DOSE PACK CARTON type: Drug Package packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] status: Active statusDate: 2020-03-30 00:00:00+0000 containedItemQuantity: 1 description: 3 in 1 CARTON MarketingStatuses - Status * Marketing copackagedIndicator: false manufacturer: Organization Pfizer Manufacturing Deutschland GmbH packaging identifier: National drug codes/NDC 0069-0284-03 type: Carton quantity: 1 ShelfLifeStorages - SpecialPrecautionsForStorage * Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in the original blister pack. manufacturer: Organization Pfizer Manufacturing Deutschland GmbH containedItem Items - Reference * ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit amount: 3
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in the original blister pack.
Generated Narrative: PackagedProductDefinition UUID-PPD-PALBOCICLIB75-TAB-WEEK Profile: PackagedProductDefinition (ePI) identifier: National drug codes/NDC 0069-0284-07 (use: official, ) name: 75 MG TABLET DOSE PACK type: Drug Package packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] status: Active statusDate: 2020-03-30 00:00:00+0000 containedItemQuantity: 1 description: 7 in 1 DOSE PACK; Type 0: Not a Combination Product MarketingStatuses - Status * Marketing copackagedIndicator: false manufacturer: Organization Pfizer Manufacturing Deutschland GmbH packaging identifier: National drug codes/NDC 0069-0284-07 type: Dose Pack quantity: 1 ShelfLifeStorages - SpecialPrecautionsForStorage * Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in the original blister pack. manufacturer: Organization Pfizer Manufacturing Deutschland GmbH containedItem Items - Reference * ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit amount: 7
7 in 1 DOSE PACK; Type 0: Not a Combination Product
Generated Narrative: PackagedProductDefinition UUID-PPD-PALBOCICLIB100-TAB-MONTH Profile: PackagedProductDefinition (ePI) identifier: National drug codes/NDC:0069-0486-03 (use: official, ) name: 100 MG TABLET DOSE PACK CARTON type: Drug Package packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] status: Active statusDate: 2020-03-30 00:00:00+0000 containedItemQuantity: 1 description: 3 in 1 CARTON MarketingStatuses - Status * Marketing copackagedIndicator: false manufacturer: Organization Pfizer Manufacturing Deutschland GmbH packaging identifier: National drug codes/NDC:0069-0486-03 type: Carton quantity: 1 ShelfLifeStorages - SpecialPrecautionsForStorage * Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in the original blister pack. manufacturer: Organization Pfizer Manufacturing Deutschland GmbH containedItem Items - Reference * ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit amount: 3
Generated Narrative: PackagedProductDefinition UUID-PPD-PALBOCICLIB100-TAB-WEEK Profile: PackagedProductDefinition (ePI) identifier: National drug codes/NDC:0069-0486-07 (use: official, ) name: 100 MG TABLET DOSE PACK type: Drug Package packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] status: Active statusDate: 2020-03-30 00:00:00+0000 containedItemQuantity: 1 description: 7 in 1 DOSE PACK; Type 0: Not a Combination Product MarketingStatuses - Status * Marketing copackagedIndicator: false manufacturer: Organization Pfizer Manufacturing Deutschland GmbH packaging identifier: National drug codes/NDC:0069-0486-07 type: Dose Pack quantity: 1 ShelfLifeStorages - SpecialPrecautionsForStorage * Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in the original blister pack. manufacturer: Organization Pfizer Ireland Pharmaceuticals Organization Pfizer Manufacturing Deutschland GmbH containedItem Items - Reference * ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit amount: 7
Generated Narrative: PackagedProductDefinition UUID-PPD-PALBOCICLIB125-TAB-MONTH Profile: PackagedProductDefinition (ePI) identifier: National drug codes/NDC:0069-0688-03 (use: official, ) name: 125 MG TABLET DOSE PACK CARTON type: Drug Package packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] status: Active statusDate: 2020-03-30 00:00:00+0000 containedItemQuantity: 1 description: 3 in 1 CARTON MarketingStatuses - Status * Marketing copackagedIndicator: false manufacturer: Organization Pfizer Manufacturing Deutschland GmbH packaging identifier: National drug codes/NDC:0069-0688-03 type: Carton quantity: 1 ShelfLifeStorages - SpecialPrecautionsForStorage * Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in the original blister pack. manufacturer: Organization Pfizer Manufacturing Deutschland GmbH containedItem Items - Reference * ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit amount: 3
Generated Narrative: PackagedProductDefinition UUID-PPD-PALBOCICLIB125-TAB-WEEK Profile: PackagedProductDefinition (ePI) identifier: National drug codes/NDC:0069-0688-07 (use: official, ) name: 125 MG TABLET DOSE PACK type: Drug Package packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] status: Active statusDate: 2020-03-30 00:00:00+0000 containedItemQuantity: 1 description: 7 in 1 DOSE PACK; Type 0: Not a Combination Product MarketingStatuses - Status * Marketing copackagedIndicator: false manufacturer: Organization Pfizer Manufacturing Deutschland GmbH packaging identifier: National drug codes/NDC:0069-0688-07 type: Dose Pack quantity: 1 ShelfLifeStorages - SpecialPrecautionsForStorage * Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in the original blister pack. manufacturer: Organization Pfizer Manufacturing Deutschland GmbH containedItem Items - Reference * ManufacturedItemDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); status = active; manufacturedDoseForm = Film Coated Tablet Dosage Form; unitOfPresentation = Tablet Dosing Unit amount: 7
Generated Narrative: RegulatedAuthorization UUID-RA-PALBOCICLIB75 Profile: RegulatedAuthorization (ePI) identifier: National drug codes/0069-0284-03 (use: official, ) subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] type: Marketing Authorization description: Pfizer - NDC 0069-0284-03 - IBRANCE® (palbociclib) tablets - 75 mg - 21 tablets - Monthly Box Contains: 3 individual weekly - packs. Each pack contains 7 IBRANCE tablets - (75 mg per tablet). Rx only region: United States of America status: Approved for Human Use Product statusDate: 2020-03-30 00:00:00+0000 validityPeriod: 2020-11-01 00:00:00+0000 --> (ongoing) holder: Organization Pfizer Laboratories Div Pfizer Inc regulator: Organization Food and Drug Administration Cases - Identifier Type Status Date[x] * urn:oid:2.16.840.1.113883.3.150/NDA212436 NDA Approved for Human Use Product 2020-03-30 00:00:00+0000
Pfizer - NDC 0069-0284-03 - IBRANCE® (palbociclib) tablets - 75 mg - 21 tablets - Monthly Box Contains: 3 individual weekly - packs. Each pack contains 7 IBRANCE tablets - (75 mg per tablet). Rx only
Generated Narrative: RegulatedAuthorization UUID-RA-PALBOCICLIB100-TAB-WEEK Profile: RegulatedAuthorization (ePI) identifier: National drug codes/0069-0486-07 (use: official, ) subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] type: Marketing Authorization description: Pfizer - NDC 0069-0486-07 - IBRANCE® (palbociclib) tablets - 100 mg per tablet - This weekly pack contains: 7 tablets - Rx only region: United States of America status: Approved for Human Use Product statusDate: 2020-03-30 00:00:00+0000 validityPeriod: 2020-11-01 00:00:00+0000 --> (ongoing) holder: Organization Pfizer Laboratories Div Pfizer Inc regulator: Organization Food and Drug Administration Cases - Identifier Type Status Date[x] * urn:oid:2.16.840.1.113883.3.150/NDA212436 NDA Approved for Human Use Product 2020-03-30 00:00:00+0000
Pfizer - NDC 0069-0486-07 - IBRANCE® (palbociclib) tablets - 100 mg per tablet - This weekly pack contains: 7 tablets - Rx only
Generated Narrative: RegulatedAuthorization UUID-RA-PALBOCICLIB125-TAB-MONTH Profile: RegulatedAuthorization (ePI) identifier: National drug codes/0069-0688-03 (use: official, ) subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] type: Marketing Authorization description: Pfizer - NDC 0069-0688-03 - IBRANCE® (palbociclib) tablets - 125 mg - 21 tablets - Monthly Box Contains: 3 individual weekly - packs. Each pack contains 7 IBRANCE tablets - (125 mg per tablet). Rx only region: United States of America status: Approved for Human Use Product statusDate: 2020-03-30 00:00:00+0000 validityPeriod: 2020-11-01 00:00:00+0000 --> (ongoing) holder: Organization Pfizer Laboratories Div Pfizer Inc regulator: Organization Food and Drug Administration Cases - Identifier Type Status Date[x] * urn:oid:2.16.840.1.113883.3.150/NDA212436 NDA Approved for Human Use Product 2020-03-30 00:00:00+0000
Pfizer - NDC 0069-0688-03 - IBRANCE® (palbociclib) tablets - 125 mg - 21 tablets - Monthly Box Contains: 3 individual weekly - packs. Each pack contains 7 IBRANCE tablets - (125 mg per tablet). Rx only
Generated Narrative: RegulatedAuthorization UUID-RA-PALBOCICLIB125 Profile: RegulatedAuthorization (ePI) identifier: National drug codes/0069-0688-07 (use: official, ) subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] type: Marketing Authorization description: Pfizer - NDC 0069-0688-07 - IBRANCE® (palbociclib) tablets - 125 mg per tablet - This weekly pack contains: 7 tablets - Rx only region: United States of America status: Approved for Human Use Product statusDate: 2020-03-30 00:00:00+0000 validityPeriod: 2020-11-01 00:00:00+0000 --> (ongoing) holder: Organization Pfizer Laboratories Div Pfizer Inc regulator: Organization Food and Drug Administration Cases - Identifier Type Status Date[x] * urn:oid:2.16.840.1.113883.3.150/NDA212436 NDA Approved for Human Use Product 2020-03-30 00:00:00+0000
Pfizer - NDC 0069-0688-07 - IBRANCE® (palbociclib) tablets - 125 mg per tablet - This weekly pack contains: 7 tablets - Rx only
Generated Narrative: ClinicalUseDefinition interaction-carbamazepine-id Profile: ClinicalUseDefinition Interaction (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/N40HCS9740 (use: official, ) type: Interaction subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] interaction Interactants - Item[x] * Carbamazepine
Generated Narrative: ClinicalUseDefinition interaction-enzalutamide-id Profile: ClinicalUseDefinition Interaction (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/4S9YUX2YRV (use: official, ) type: Interaction subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] interaction Interactants - Item[x] * Enzalutamide
Generated Narrative: ClinicalUseDefinition interaction-stjohnswort-id Profile: ClinicalUseDefinition Interaction (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/G2M3PPT97G (use: official, ) type: Interaction subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] interaction Interactants - Item[x] * St John’s Wort
Generated Narrative: ClinicalUseDefinition interaction-alfentanil-id Profile: ClinicalUseDefinition Interaction (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/1HCV40FHJT (use: official, ) type: Interaction subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] interaction Interactants - Item[x] * Alfentanil
Generated Narrative: ClinicalUseDefinition interaction-cyclosporine-id Profile: ClinicalUseDefinition Interaction (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/83HN0GTJ6D (use: official, ) type: Interaction subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] interaction Interactants - Item[x] * Cyclosporine
Generated Narrative: ClinicalUseDefinition interaction-dihydroergotamine-id Profile: ClinicalUseDefinition Interaction (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/4L4Z42S42Y (use: official, ) type: Interaction subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] interaction Interactants - Item[x] * Dihydroergotamine
Generated Narrative: ClinicalUseDefinition interaction-ergotamine-id Profile: ClinicalUseDefinition Interaction (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/LH5S7Z74VZ (use: official, ) type: Interaction subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] interaction Interactants - Item[x] * Ergotamine
Generated Narrative: ClinicalUseDefinition interaction-everolimus-id Profile: ClinicalUseDefinition Interaction (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/8J18F9030N (use: official, ) type: Interaction subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] interaction Interactants - Item[x] * Everolimus
Generated Narrative: ClinicalUseDefinition interaction-fentanyl-id Profile: ClinicalUseDefinition Interaction (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/AN3HR2L44E (use: official, ) type: Interaction subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] interaction Interactants - Item[x] * Fentanyl
Generated Narrative: ClinicalUseDefinition interaction-pimozide-id Profile: ClinicalUseDefinition Interaction (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/HOP0PPN3MB (use: official, ) type: Interaction subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] interaction Interactants - Item[x] * Pimozide
Generated Narrative: ClinicalUseDefinition interaction-quinidine-id Profile: ClinicalUseDefinition Interaction (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/2J18XH63HH (use: official, ) type: Interaction subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] interaction Interactants - Item[x] * Quinidine
Generated Narrative: ClinicalUseDefinition interaction-sirolimus-id Profile: ClinicalUseDefinition Interaction (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/W36ZG6FT64 (use: official, ) type: Interaction subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] interaction Interactants - Item[x] * Sirolimus
Generated Narrative: ClinicalUseDefinition interaction-tacrolimus-id Profile: ClinicalUseDefinition Interaction (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/Y5L2157C4J (use: official, ) type: Interaction subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] interaction Interactants - Item[x] * Tacrolimus
Generated Narrative: ClinicalUseDefinition indication-hrposher2 Profile: ClinicalUseDefinition Indication (ePI) identifier: http://example.org/sid/767444009 type: Indication subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0284 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0486 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0069-0688 (use: official, ); type = Approved for Human Use Product; domain = Human; version = 1; status = Active; statusDate = 2020-03-30 00:00:00+0000; combinedPharmaceuticalDoseForm = Film Coated Tablet Dosage Form; legalStatusOfSupply = Marketing Authorization; classification = Kinase Inhibitor [EPC] indication DiseaseSymptomProcedures - Concept * Germline BRCA-mutated human epidermal growth factor receptor 2 negative metastatic carcinoma of breast (disorder)
Germline BRCA-mutated human epidermal growth factor receptor 2 negative metastatic carcinoma of breast (disorder)