Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build

Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/gravitate-health and changes regularly. See the Directory of published versions

Example Bundle: ePI document Bundle for Ogivri Package Leaflet for language en

Composition category: Raw
Composition status: final

Narrative Text


B. Package Leaflet

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Package leaflet: Information for the user

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What is in this leaflet

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1. What Ogivri 150 mg powder for concentrate for solution for infusion is and what it is used for

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2. What you need to know before you take Ogivri 150 mg powder for concentrate for solution for infusion

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3. How to take Ogivri 150 mg powder for concentrate for solution for infusion

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4. Possible side effects

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5. How to store Ogivri 150 mg powder for concentrate for solution for infusion

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6. Contents of the pack and other information

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Product Information

Ogivri 150 mg powder for concentrate for solution for infusion

4: 7532F47F36A3585D1F348BBDDA057862

Full name: Ogivri 150 mg powder for concentrate for solution for infusion

- Invented name part: Ogivri

- Scientific name part: trastuzumab

- Strength part: 150 mg

- Pharmaceutical dose form part: powder for concentrate for solution for infusion

Name usage: English (Norway)

Authorised dose form:

Legal status of supply: Medicinal product subject to medical prescription

Domain: Human use

Resource status: active

Product classification:

Marketing Authorisation 1 of 1

Authorisation number: EU/1/18/1341/001

Region:

Marketing authorisation holder: Viatris Limited

Identifier:

  • ORG-100034260

Status: Active (2018-12-12T00:00:00Z)

Package 1 of 1

PMSWI: EU/1/18/1341/001

Description:

Marketing status:

Pack size:

  • 150

Package: 1 Box (Cardboard)

Containing:

Package: 1 Vial (Glass type I)

Containing:

Manufactured Item

Dose form: Powder for concentrate for solution for infusion

Unit of presentation: Vial

Ingredient

Role: Excipient

Substance: SORBITOL

Ingredient

Role: Active

Substance: trastuzumab

Administrable Product (1 of 1)

Dose form: Solution for injection

Unit of presentation: Vial

Route of administration:

  • Intravenous use

Ingredients:

Ingredient

Role: Excipient

Substance: SORBITOL

Ingredient

Role: Active

Substance: trastuzumab