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        v: Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
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        v: What is in this leaflet What Suliqua is and what it is used for What you need to know before you use Suliqua 3. How to use Suliqua Possible side effects How to store Suliqua Contents of the pack and other information
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        v: Suliqua is an injectable diabetes medicine that contains two active substances: insulin glargine: a long-acting type of insulin which helps control blood sugar (glucose) throughout the day. lixisenatide: a “GLP-1 analogue” that helps the body produce its own additional insulin in response to increases in blood sugar, and slows the absorption of sugar from foods. Suliqua is used to treat adults with type 2 diabetes, to help control blood sugar levels when they are too high, it is an adjunct to diet and exercise. It is given, with metformin with or without sodium- glucose co-transporter-2 (SGLT2) inhibitors (gliflozin products), when other medicines are not enough on their own to control your blood sugar levels.
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        v: Do not use Suliqua: if you are allergic to insulin glargine or lixisenatide or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before using Suliqua if: you have type 1 diabetes, as Suliqua is used for type 2 diabetes and this medicine will not be right for you. you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to use glucose because there is not enough insulin) since this medicine will not be right for you. you have a severe stomach or gut problem such as a disease of the muscles of the stomach called “gastroparesis” which results in delayed stomach emptying. Since Suliqua may cause stomach side effects (see section 4), the medicine has not been studied in patients with severe stomach or gut problems. Please see the information regarding medicines that should not stay too long in your stomach in the section “Other medicines and Suliqua”. you have severe kidney disease or you are on dialysis as the use of this medicine will not be recommended. Follow closely your doctor’s instructions for dose, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) and injection technique. Be especially aware of the following: Too low blood sugar (hypoglycaemia). If your blood sugar is too low, follow the guidance for hypoglycaemia (see information in the box at the end of this leaflet). Too high blood sugar (hyperglycaemia). If your blood sugar is too high, follow the guidance for hyperglycaemia (see information in the box at the end of this leaflet). Ensure that you use the right medicine. You must always check the label before each injection to avoid mix-ups between Suliqua and other insulins. If you have poor eyesight, please see section 3. While using this medicine be aware of the following and talk to your doctor, pharmacist or nurse before using Suliqua: severe pain in your stomach area (abdomen) that will n…
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        v: Always use this medicine exactly as your doctor has told you. Your doctor may tell you to use a different dose of Suliqua compared to your previous insulin dose or glucose lowering medicine if any. Check with your doctor, pharmacist or nurse if you are not sure. Based on your lifestyle, your blood sugar tests and your previous insulin use, your doctor will tell you: How much Suliqua you need each day and at what time. When to check your blood sugar level and if you need to carry out urine tests. When you may need a higher or lower dose. Your doctor may tell you to use Suliqua with other medicines for high blood sugar. How much to use Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen: This pen provides a dose of 10 to 40 dose steps in one injection, in steps of 1 dose step. Each dose step you dial contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide. Your dose of Suliqua is administered as ‘dose steps’. The dose window on the pen shows the number of dose steps. Do not inject a dose lower than 10 dose steps. Do not inject a dose higher than 40 dose steps. If a dose greater than 40 dose steps is needed, your doctor will prescribe a different strength. For dose steps from 30-60 units, Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen is available. Many factors may affect your blood sugar level. You should know what they are so that you can take the right action if your blood sugar level changes and help stop it becoming too high or too low. See the box at the end of this leaflet for more information. Use in elderly patients (65 years and older) If you are 65 years or older, talk to your doctor as you may need a lower dose. If you have kidney or liver problems If you have kidney or liver problems, talk to your doctor as you may need a lower dose. When to inject Suliqua Use Suliqua once a day, within 1 hour before a meal. Preferably inject Suliqua before the same meal every day, when you have …
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        v: Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice signs of your blood sugar being too low (hypoglycaemia), take action to increase your blood sugar level straightaway (see the box at the end of this leaflet). Hypoglycaemia can be very serious and is very common with medicines containing insulin (may affect more than 1 in 10 people). Low blood sugar means that there is not enough sugar in your blood. If your blood sugar falls too low, you may pass out (become unconscious). If blood sugar remains very low for too long it may cause brain damage and may be life-threatening. For more information, see the box at the end of this leaflet. Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects: Skin changes at the injection site If you inject insulin too often at the same place, the skin may either shrink (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis). This is not known how often these skin changes occur. The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes. Common (may affect up to 1 in 10 people) Feeling dizzy Feeling sick (nausea) V omiting Diarrhoea Skin and allergic reactions at the injection site: The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation. This can spread around the injection site. Most minor reactions to insulins usually disappear in a few days to a few weeks. Uncommon (may affect up to 1 in 100 people) Cold, runny nose, sore throat Hives (urticaria) Headache Indigestion (dyspepsia) Stomach ache Tiredness Rare (may affect up to 1 in 1,000 people) A delay in the emptying of the stomach Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any pos…
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        v: Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after “EXP”. The expiry date refers to the last day of that month. Before first use Store in a refrigerator (2°C-8°C). Do not freeze or place next to the freezer compartment or a freezer pack. Keep the pen in the outer carton in order to protect from light. After first use Store your pen in use below 25°C for a maximum of 28 days. Discard the pen after this period. Do not return the pen to a refrigerator and do not freeze. Store the pen away from direct heat or direct light. Always keep the cap on the pen when you are not using it in order to protect it from light. Do not leave the pen in a car on an exceptionally warm or cold day. Do not store the pen with the needle attached. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer used. These measures will help protect the environment.
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        v: What Suliqua contains The active substances are insulin glargine and lixisenatide. Each pen contains 300 units insulin glargine and 150 micrograms lixisenatide in 3 ml of solution. Each ml contains 100 units insulin glargine and 50 micrograms lixisenatide. Each dose step of Suliqua contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide. The other ingredients are: glycerol 85%, methionine, metacresol, zinc chloride, concentrated hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections. See also section 2 “What you need to know before you use Suliqua” for information on sodium and metacresol. What Suliqua looks like and contents of the pack Suliqua is a clear and colourless solution for injection (injection) filled in a glass cartridge inserted in a pre-filled pen (SoloStar). Pack sizes of 3, 5 and 10 pre-filled pens. Not all pack sizes may be marketed. Marketing Authorisation Holder Sanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly France Manufacturer Sanofi-Aventis Deutschland GmbH Industriepark Höchst - 65926 Frankfurt am Main Germany

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    v: Generated Narrative: Ingredient ingredient-for-suliqua-glycerol85whodd Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/PDC6A3C0OX (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#xxx (use: official, ); status = active; manufacturedDoseForm = Solution; unitOfPresentation = Pen MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/16/1157/002; type = Medicinal Product; domain = Human use; status = active; indication = Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = insulin glargine and lixisenatide AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#id; status = active; administrableDoseForm = Solution; unitOfPresentation = Pen role: Excipient substance Codes - Concept * GLYCEROL 85% [WHO-DD]
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: PDC6A3C0OX
status:
  v: active
for:
  l: mp367b9089c0743a2330f4c6e82b40ee41
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-suliqua-methionine
type: Ingredient
id:
  v: ingredient-for-suliqua-methionine
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-suliqua-methionine Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/AE28F7PNPL (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#xxx (use: official, ); status = active; manufacturedDoseForm = Solution; unitOfPresentation = Pen MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/16/1157/002; type = Medicinal Product; domain = Human use; status = active; indication = Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = insulin glargine and lixisenatide AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#id; status = active; administrableDoseForm = Solution; unitOfPresentation = Pen role: Excipient substance Codes - Concept * Methionine
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: AE28F7PNPL
status:
  v: active
for:
  l: mp367b9089c0743a2330f4c6e82b40ee41
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-suliqua-metacresol
type: Ingredient
id:
  v: ingredient-for-suliqua-metacresol
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-suliqua-metacresol Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/GGO4Y809LO (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#xxx (use: official, ); status = active; manufacturedDoseForm = Solution; unitOfPresentation = Pen MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/16/1157/002; type = Medicinal Product; domain = Human use; status = active; indication = Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = insulin glargine and lixisenatide AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#id; status = active; administrableDoseForm = Solution; unitOfPresentation = Pen role: Excipient substance Codes - Concept * Metacresol
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: GGO4Y809LO
status:
  v: active
for:
  l: mp367b9089c0743a2330f4c6e82b40ee41
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-suliqua-zincchloride
type: Ingredient
id:
  v: ingredient-for-suliqua-zincchloride
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-suliqua-zincchloride Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/86Q357L16B (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#xxx (use: official, ); status = active; manufacturedDoseForm = Solution; unitOfPresentation = Pen MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/16/1157/002; type = Medicinal Product; domain = Human use; status = active; indication = Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = insulin glargine and lixisenatide AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#id; status = active; administrableDoseForm = Solution; unitOfPresentation = Pen role: Excipient substance Codes - Concept * Zinc chloride
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 86Q357L16B
status:
  v: active
for:
  l: mp367b9089c0743a2330f4c6e82b40ee41
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-suliqua-hydrochloricacidiarc
type: Ingredient
id:
  v: ingredient-for-suliqua-hydrochloricacidiarc
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-suliqua-hydrochloricacidiarc Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/QTT17582CB (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#xxx (use: official, ); status = active; manufacturedDoseForm = Solution; unitOfPresentation = Pen MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/16/1157/002; type = Medicinal Product; domain = Human use; status = active; indication = Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = insulin glargine and lixisenatide AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#id; status = active; administrableDoseForm = Solution; unitOfPresentation = Pen role: Excipient substance Codes - Concept * HYDROCHLORIC ACID [IARC]
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: QTT17582CB
status:
  v: active
for:
  l: mp367b9089c0743a2330f4c6e82b40ee41
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-suliqua-sterilewaterforinjection
type: Ingredient
id:
  v: ingredient-for-suliqua-sterilewaterforinjection
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-suliqua-sterilewaterforinjection Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/059QF0KO0R (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#xxx (use: official, ); status = active; manufacturedDoseForm = Solution; unitOfPresentation = Pen MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/16/1157/002; type = Medicinal Product; domain = Human use; status = active; indication = Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = insulin glargine and lixisenatide AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#id; status = active; administrableDoseForm = Solution; unitOfPresentation = Pen role: Excipient substance Codes - Concept * STERILE WATER FOR INJECTION
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 059QF0KO0R
status:
  v: active
for:
  l: mp367b9089c0743a2330f4c6e82b40ee41
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-suliqua-sodiumhydroxide
type: Ingredient
id:
  v: ingredient-for-suliqua-sodiumhydroxide
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-suliqua-sodiumhydroxide Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/55X04QC32I (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#xxx (use: official, ); status = active; manufacturedDoseForm = Solution; unitOfPresentation = Pen MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/16/1157/002; type = Medicinal Product; domain = Human use; status = active; indication = Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = insulin glargine and lixisenatide AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#id; status = active; administrableDoseForm = Solution; unitOfPresentation = Pen role: Excipient substance Codes - Concept * Sodium hydroxide
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 55X04QC32I
status:
  v: active
for:
  l: mp367b9089c0743a2330f4c6e82b40ee41
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

substance-insulinglargine
type: SubstanceDefinition
id:
  v: substance-insulinglargine
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-insulinglargine Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//2ZM8CX04RZ (use: official, ) status: Active manufacturer: Organization Sanofi-Aventis Groupe
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: 2ZM8CX04RZ
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active

substance-lixisenatide
type: SubstanceDefinition
id:
  v: substance-lixisenatide
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-lixisenatide Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//74O62BB01U (use: official, ) status: Active manufacturer: Organization Sanofi-Aventis Groupe
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: 74O62BB01U
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active

http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-e2464a7d3d627b9df9bef5bc3b263fb4
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-e2464a7d3d627b9df9bef5bc3b263fb4 Profile: AdministrableProductDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/id status: Active formOf: MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi/#/#EU/1/16/1157/002; type = Medicinal Product; domain = Human use; status = active; indication = Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = insulin glargine and lixisenatide administrableDoseForm: Solution unitOfPresentation: Pen producedFrom: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#xxx (use: official, ); status = active; manufacturedDoseForm = Solution; unitOfPresentation = Pen routeOfAdministration code: Subcutaneous use TargetSpecies - Code * Human
identifier:
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: id
status:
  v: active
form of:
  l: mp367b9089c0743a2330f4c6e82b40ee41
administrable dose form:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 200000016420
    display:
      v: Solution
unit of presentation:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 200000002135
    display:
      v: Pen
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/authorizatione2464a7d3d627b9df9bef5bc3b263fb40
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 authorizatione2464a7d3d627b9df9bef5bc3b263fb40 Profile: RegulatedAuthorization (ePI) identifier: https://spor.ema.europa.eu/pmswi/EU/1/16/1157/001 (use: official, ) subject: PackagedProductDefinition Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen 3 type: Marketing Authorisation status: Active statusDate: 2017-01-11 13:28:17+0000 holder: Organization Sanofi-Aventis Groupe
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: EU/1/16/1157/001
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: 2017-01-11T13:28:17Z

http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorizatione2464a7d3d627b9df9bef5bc3b263fb41
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 authorizatione2464a7d3d627b9df9bef5bc3b263fb41 Profile: RegulatedAuthorization (ePI) identifier: https://spor.ema.europa.eu/pmswi/EU/1/16/1157/002 (use: official, ) subject: PackagedProductDefinition Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen 5 type: Marketing Authorisation status: Active statusDate: 2017-01-11 13:28:17+0000 holder: Organization Sanofi-Aventis Groupe
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: EU/1/16/1157/002
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: 2017-01-11T13:28:17Z

http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorizatione2464a7d3d627b9df9bef5bc3b263fb42
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 authorizatione2464a7d3d627b9df9bef5bc3b263fb42 Profile: RegulatedAuthorization (ePI) identifier: https://spor.ema.europa.eu/pmswi/EU/1/16/1157/005 (use: official, ) subject: PackagedProductDefinition Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen 10 type: Marketing Authorisation status: Active statusDate: 2017-01-11 13:28:17+0000 holder: Organization Sanofi-Aventis Groupe regulator: Organization European Medicines Agency
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: EU/1/16/1157/005
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: 2017-01-11T13:28:17Z

http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-16019cea3a857659d2c5a2018c2260df
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-16019cea3a857659d2c5a2018c2260df Profile: Organization (ePI) identifier: https://spor.ema.europa.eu/omswi/ORG-100000789 (use: official, ) active: true type: Marketing authorisation holder name: Sanofi-Aventis Groupe Contacts - Address * 54, rue La Boétie F-75008 Paris FR(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: Sanofi-Aventis Groupe
contact:
  address:
    use:
      v: work
    type:
      v: physical
    text:
      v: 54, rue La Boétie F-75008 Paris FR
    line:
      v: 54, rue La Boétie F-75008
    city:
      v: Paris
    country:
      v: FR

http://hl7.eu/fhir/ig/gravitate-health/Organization/man-174ad598bd1faddba2098648a45613e1
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 man-174ad598bd1faddba2098648a45613e1 Profile: Organization (ePI) identifier: https://spor.ema.europa.eu/omswi/ORG-100001175 (use: official, ) active: true type: Manufacturer name: Sanofi-Aventis Deutschland GmbH Contacts - Address * Brueningstrasse 50, Industriepark Höchst Frankfurt am Main de(work)
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/omswi
    l: omswi
  value:
    v: ORG-100001175
active:
  v: true
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 220000000033
    display:
      v: Manufacturer
name:
  v: Sanofi-Aventis Deutschland GmbH
contact:
  address:
    use:
      v: work
    type:
      v: physical
    text:
      v: Brueningstrasse 50, Industriepark Höchst Frankfurt am Main de
    line:
      v: Brueningstrasse 50, Industriepark Höchst
    city:
      v: Frankfurt am Main
    postal code:
      v: 65926.0
    country:
      v: de

http://hl7.eu/fhir/ig/gravitate-health/Organization/mra-ff74c5498eb163c2fb470e9fd175a0c1
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:
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http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-f1cc049dd00785b744b0e0fb928c8569
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v: 100000155538

v: 100000155538

v: 10020772

v: Hypertension

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v: active ingredient - basis of strength

v: 74O62BB01U

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v: active ingredient - basis of strength

v: PDC6A3C0OX

v: GLYCEROL 85% [WHO-DD]

v: AE28F7PNPL

v: Methionine

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v: Metacresol

v: 86Q357L16B

v: Zinc chloride

v: QTT17582CB

v: HYDROCHLORIC ACID [IARC]

v: 059QF0KO0R

v: STERILE WATER FOR INJECTION

v: 55X04QC32I

v: Sodium hydroxide

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v: urn:iso:std:iso:3166
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v: DK

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l: 3166

v: DK

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

v: en

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