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http://hl7.eu/fhir/ig/gravitate-health/Composition/composition-en-f97db27e6330f77484eb8425ad2913cd
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      v: Package leaflet: Information for the user
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        v: Package leaflet: Information for the user
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        v: Humira 40 mg solution for injection in pre-filled syringe adalimumab Read all of this leaflet carefully before your child starts using this medicine because it contains important information. Keep this leaflet. You may need to read it again. Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before your child begins using Humira and during treatment with Humira. Keep this Patient Reminder Card with you or your child. If you have any questions, ask your doctor or pharmacist. This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child. If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
  section:
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      v: What is in this leaflet
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        v: What is in this leaflet
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        v: What is in this leaflet What Humira is and what it is used for What you need to know before your child uses Humira How to use Humira Possible side effects How to store Humira Contents of the pack and other information Injecting Humira
  section:
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      v: 1. What 0 is and what it is used for
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        v: 1. What 0 is and what it is used for
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        v: What Humira is and what it is used for Humira contains the active substance adalimumab. Humira is intended for the treatment of the inflammatory diseases described below: Polyarticular juvenile idiopathic arthritis Enthesitis-related arthritis Paediatric plaque psoriasis Paediatric Crohn’s disease Paediatric uveitis The active ingredient in Humira, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target. The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNFα, Humira decreases the process of inflammation in these diseases. Polyarticular juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints that usually first appears in childhood. Humira is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age. Your child may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, your child will be given Humira to treat his/her polyarticular juvenile idiopathic arthritis. Your doctor will decide if Humira should be used with methotrexate or alone. Enthesitis-related arthritis Enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone. Humira is used to treat enthesitis-related arthritis in patients from 6 years of age. Your child may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, your child will be given Humira to treat his/her enthesitis-related arthritis. Paediatric plaque psoriasis Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift…
  section:
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      v: 2. What you need to know before you take 0
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        v: 2. What you need to know before you take 0
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        v: Warnings and precautions Talk to your doctor or pharmacist before using Humira. Allergic reactions If your child gets allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Humira and contact your doctor immediately since, in rare cases, these reactions can be life threatening. Infections If your child has an infection, including long-term infection or an infection in one part of the body (for example, leg ulcer) consult your doctor before starting Humira. If you are unsure, contact your doctor. Your child might get infections more easily while he/she is receiving Humira treatment. This risk may increase if your child has problems with his/her lungs. These infections may be serious and include: tuberculosis infections caused by viruses, fungi, parasites or bacteria severe infection in the blood (sepsis) In rare cases, these infections can be life-threatening. It is important to tell your doctor if your child gets symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may tell you to stop using Humira for some time. Tell your doctor if your child lives or travels in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common. Tell your doctor if your child has had infections which keep coming back or other conditions that increase the risk of infections. Your child and his/her doctor should pay special attention to signs of infection while your child is being treated with Humira. It is important to tell your doctor if your child gets symptoms of infections, such as fever, wounds, feeling tired or dental problems. Tuberculosis As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check your child for signs and symptoms of tuberculosis before starting Humira. This will include a thorough medical evaluation including your child’s medical history and appropriate screening tests (for example, ches…
  section:
    title:
      v: 3. How to take 0
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      text:
        v: 3. How to take 0
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        v: How to use Humira Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended doses for Humira in each of the approved uses are shown in the following table. Your doctor may prescribe another strength of Humira if your child needs a different dose. Method and route of administration Humira is administered by injection under the skin (by subcutaneous injection). Detailed instructions on how to inject Humira are provided in section 7 ‘Injecting Humira’. If you use more Humira than you should If you accidentally inject Humira more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell them that your child has taken more. Always take the outer carton of the medicine with you, even if it is empty. If you forget to use Humira If you forget to give your child an injection, you should inject the next dose of Humira as soon as you remember. Then give your child’s next dose as you would have on the originally scheduled day, had you not forgotten a dose. If you stop using Humira The decision to stop using Humira should be discussed with your doctor. Your child’s symptoms may return if you stop using Humira. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
  section:
    title:
      v: 4. Possible side effects
    code:
      text:
        v: 4. Possible side effects
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        v: additional
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        v: Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur at least up to 4 months after the last Humira injection. Tell your doctor immediately if you notice any of the following severe rash, hives or other signs of allergic reaction swollen face, hands, feet trouble breathing, swallowing shortness of breath with physical activity or upon lying down or swelling of the feet Tell your doctor as soon as possible if you notice any of the following signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination feeling weak or tired coughing tingling numbness double vision arm or leg weakness a bump or open sore that doesn't heal signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness The symptoms described above can be signs of the below listed side effects, which have been observed with Humira. Very common (may affect more than 1 in 10 people) injection site reactions (including pain, swelling, redness or itching) respiratory tract infections (including cold, runny nose, sinus infection, pneumonia) headache abdominal pain nausea and vomiting rash musculoskeletal pain Common (may affect up to 1 in 10 people) serious infections (including blood poisoning and influenza) intestinal infections (including gastroenteritis) skin infections (including cellulitis and shingles) ear infections oral infections (including tooth infections and cold sores) reproductive tract infections urinary tract infection fungal infections joint infections benign tumours skin cancer allergic reactions (including seasonal allergy) dehydration mood swings (including depression) anxiety difficulty sleeping sensation disorders such as tingling, prickling or numbness migraine nerve root compression (including low back pain and leg pain) vision disturbances e…
  section:
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      v: 5. How to store 0
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        v: 5. How to store 0
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        v: How to store Humira Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label/blister/carton after EXP. Store in a refrigerator (2ºC – 8ºC). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light. Alternative Storage: When needed (for example, when you are travelling), a single Humira pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, the syringe must be used within 14 days or discarded, even if it is returned to the refrigerator. You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded. Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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      v: 6. Contents of the pack and other information
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        v: 6. Contents of the pack and other information
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    v: Generated Narrative: Ingredient ingredient-for-humira-sodiumcitrateunspecifiedform Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/1Q73Q2JULR (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/03/256/001 (use: official, ); status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Syringe MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/03/256/022,https://www.who-umc.org/phpid#0xe72f98caa2b13cb3ccb489a1a7945c91; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#nan; status = active; administrableDoseForm = Solution for injection; unitOfPresentation = Syringe role: Excipient substance Codes - Concept * SODIUM CITRATE, UNSPECIFIED FORM
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 1Q73Q2JULR
status:
  v: active
for:
  l: mpf97db27e6330f77484eb8425ad2913cd
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-humira-sodiumphosphatemonobasicdihydrate
type: Ingredient
id:
  v: ingredient-for-humira-sodiumphosphatemonobasicdihydrate
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-humira-sodiumphosphatemonobasicdihydrate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/5QWK665956 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/03/256/001 (use: official, ); status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Syringe MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/03/256/022,https://www.who-umc.org/phpid#0xe72f98caa2b13cb3ccb489a1a7945c91; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#nan; status = active; administrableDoseForm = Solution for injection; unitOfPresentation = Syringe role: Excipient substance Codes - Concept * SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 5QWK665956
status:
  v: active
for:
  l: mpf97db27e6330f77484eb8425ad2913cd
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-humira-sodiumphosphatedibasicdihydrate
type: Ingredient
id:
  v: ingredient-for-humira-sodiumphosphatedibasicdihydrate
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-humira-sodiumphosphatedibasicdihydrate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/94255I6E2T (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/03/256/001 (use: official, ); status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Syringe MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/03/256/022,https://www.who-umc.org/phpid#0xe72f98caa2b13cb3ccb489a1a7945c91; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#nan; status = active; administrableDoseForm = Solution for injection; unitOfPresentation = Syringe role: Excipient substance Codes - Concept * SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 94255I6E2T
status:
  v: active
for:
  l: mpf97db27e6330f77484eb8425ad2913cd
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-humira-sodiumchloride
type: Ingredient
id:
  v: ingredient-for-humira-sodiumchloride
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-humira-sodiumchloride Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/451W47IQ8X (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/03/256/001 (use: official, ); status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Syringe MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/03/256/022,https://www.who-umc.org/phpid#0xe72f98caa2b13cb3ccb489a1a7945c91; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#nan; status = active; administrableDoseForm = Solution for injection; unitOfPresentation = Syringe role: Excipient substance Codes - Concept * Sodium chloride
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 451W47IQ8X
status:
  v: active
for:
  l: mpf97db27e6330f77484eb8425ad2913cd
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

substance-adalimumab
type: SubstanceDefinition
id:
  v: substance-adalimumab
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi
    l: SubstanceDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: SubstanceDefinition substance-adalimumab Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//FYS6T7F842 (use: official, ) version: 1 status: Active manufacturer: Organization ACME industry Structures - MolecularFormula * C6448H10026O2016N1732S42
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: FYS6T7F842
version:
  v: 1
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
structure:
  molecular formula:
    v: C6448H10026O2016N1732S42

http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-9b5b17469311c2ea4d1d08419748b4fb
type: AdministrableProductDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi
    l: AdministrableProductDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: AdministrableProductDefinition ap-9b5b17469311c2ea4d1d08419748b4fb Profile: AdministrableProductDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/nan status: Active formOf: MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/03/256/022,https://www.who-umc.org/phpid#0xe72f98caa2b13cb3ccb489a1a7945c91; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription administrableDoseForm: Solution for injection unitOfPresentation: Syringe producedFrom: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/03/256/001 (use: official, ); status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Syringe routeOfAdministration code: Subcutaneous use TargetSpecies - Code * Human
identifier:
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: nan
status:
  v: active
form of:
  l: mpf97db27e6330f77484eb8425ad2913cd
administrable dose form:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000073863
    display:
      v: Solution for injection
unit of presentation:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 200000002150
    display:
      v: Syringe
route of administration:
  code:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 100000073633
      display:
        v: Subcutaneous use

http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization9b5b17469311c2ea4d1d08419748b4fb0
type: RegulatedAuthorization
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi
    l: RegulatedAuthorization-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization authorization9b5b17469311c2ea4d1d08419748b4fb0 Profile: RegulatedAuthorization (ePI) identifier: https://spor.ema.europa.eu/pmswi/EU/1/03/256/022 (use: official, ) subject: MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/03/256/022,https://www.who-umc.org/phpid#0xe72f98caa2b13cb3ccb489a1a7945c91; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription type: Marketing Authorisation status: Active statusDate: 2008-09-08 holder: Organization ACME industry
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: EU/1/03/256/022
subject:
  l: mpf97db27e6330f77484eb8425ad2913cd
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 220000000061
    display:
      v: Marketing Authorisation
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
    display:
      v: Active
status date:
  v: 2008-09-08

http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-63db764f02d280689a772e5827bb2515
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi
    l: Organization-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Organization mah-63db764f02d280689a772e5827bb2515 Profile: Organization (ePI) identifier: https://spor.ema.europa.eu/omswi/ORG-100000789 (use: official, ) active: true type: Marketing authorisation holder name: ACME industry Contacts - Address * Knollstrasse Ludwigshafen Am Rhein Germany(work)
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/omswi
    l: omswi
  value:
    v: ORG-100000789
active:
  v: true
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 220000000034
    display:
      v: Marketing authorisation holder
name:
  v: ACME industry
contact:
  address:
    use:
      v: work
    type:
      v: physical
    text:
      v: Knollstrasse Ludwigshafen Am Rhein Germany
    line:
      v: Knollstrasse
    city:
      v: Ludwigshafen Am Rhein
    postal code:
      v: 67061
    country:
      v: Germany

http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-8cd75434ddd15aca2f0bc2efe5d26afe
type: PackagedProductDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi
    l: PackagedProductDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: PackagedProductDefinition ppd-8cd75434ddd15aca2f0bc2efe5d26afe Profile: PackagedProductDefinition (ePI) name: Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass) 2 type: Chemical Medicinal Product packageFor: MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/03/256/022,https://www.who-umc.org/phpid#0xe72f98caa2b13cb3ccb489a1a7945c91; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription status: Active statusDate: 2008-09-08 packaging type: Box quantity: 1 material: Cardboard packaging identifier: https://spor.ema.europa.eu/pmswi/123456 type: Pre-filled syringe quantity: 2 material: Glass type I containedItem Items - Reference * ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/03/256/001 (use: official, ); status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Syringe
name:
  v: Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass) 2
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000155527
    display:
      v: Chemical Medicinal Product
package for:
  l: mpf97db27e6330f77484eb8425ad2913cd
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
    display:
      v: Active
status date:
  v: 2008-09-08
packaging:
  type:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 100000073498
      display:
        v: Box
  quantity:
    v: 1
  material:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 200000003529
      display:
        v: Cardboard
  packaging:
    identifier:
      system:
        v: https://spor.ema.europa.eu/pmswi
        l: pmswi
      value:
        v: 123456
    quantity:
      v: 2

mpf97db27e6330f77484eb8425ad2913cd
type: MedicinalProductDefinition
id:
  v: mpf97db27e6330f77484eb8425ad2913cd
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi
    l: MedicinalProductDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: MedicinalProductDefinition mpf97db27e6330f77484eb8425ad2913cd Profile: MedicinalProductDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/EU/1/03/256/022, https://www.who-umc.org/phpid/0xe72f98caa2b13cb3ccb489a1a7945c91 type: Medicinal Product domain: Human use status: active legalStatusOfSupply: Medicinal product subject to medical prescription name productName: Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass) type: Full name part part: Humira type: Invented name part part part: Adalimumab type: Scientific name part part part: 40 mg type: Strength part part part: Solution for injection type: Pharmaceutical dose form part Usages - Country Jurisdiction Language * Spain Spain English
identifier:
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: EU/1/03/256/022
identifier:
  system:
    v: https://www.who-umc.org/phpid
    l: phpid
  value:
    v: 0xe72f98caa2b13cb3ccb489a1a7945c91
type:
  coding:
    system:
      v: http://hl7.org/fhir/medicinal-product-type
      l: medicinal-product-type
    code:
      v: MedicinalProduct
    display:
      v: Medicinal Product
domain:
  coding:
    system:
      v: http://hl7.org/fhir/medicinal-product-domain
      l: medicinal-product-domain
    code:
      v: Human
    display:
      v: Human use
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
    display:
      v: active
legal status of supply:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072084
    display:
      v: Medicinal product subject to medical prescription
name:
  product name:
    v: Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass)
  type:
    coding:
      system:
        v: https://spor.ema.europa.eu/lists/220000000000
        l: https://spor.ema.europa.eu/lists/220000000000
      code:
        v: 220000000001
      display:
        v: Full name
  part:
    part:
      v: Humira
  part:
    part:
      v: Adalimumab
  part:
    part:
      v: 40 mg
  part:
    part:
      v: Solution for injection

http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-9b5b17469311c2ea4d1d08419748b4fb
type: ManufacturedItemDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi
    l: ManufacturedItemDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ManufacturedItemDefinition mid-9b5b17469311c2ea4d1d08419748b4fb Profile: ManufacturedItemDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/EU/1/03/256/001 (use: official, ) status: Active manufacturedDoseForm: Solution for injection unitOfPresentation: Syringe
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: EU/1/03/256/001
status:
  v: active
manufactured dose form:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi/
      l: rmswi
    code:
      v: 100000073863
    display:
      v: Solution for injection
unit of presentation:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 200000002150
    display:
      v: Syringe

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: 100000155538

v: unavailable

v: 3OWL53L36A

v: Mannitol

v: 6OZP39ZG8H

v: Polysorbate 80

v: FYS6T7F842

v: adalimumab

v: ACTIB

v: active ingredient - basis of strength

v: 059QF0KO0R

v: STERILE WATER FOR INJECTION

v: 2968PHW8QP

v: CITRIC ACID MONOHYDRATE

v: 1Q73Q2JULR

v: SODIUM CITRATE, UNSPECIFIED FORM

v: 5QWK665956

v: SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE

v: 94255I6E2T

v: SODIUM PHOSPHATE, DIBASIC, DIHYDRATE

v: 451W47IQ8X

v: Sodium chloride

v: 100000109093

v: Human

v: 100000073544

v: Pre-filled syringe

v: 200000003204

v: Glass type I

v: 220000000002

v: Invented name part

v: 220000000003

v: Scientific name part

v: 220000000004

v: Strength part

v: 220000000005

v: Pharmaceutical dose form part

v: urn:iso:std:iso:3166
l: 3166

v: ES

v: Spain

v: urn:iso:std:iso:3166
l: 3166

v: ES

v: Spain

v: urn:ietf:bcp:47
l: 47

v: en

v: English