UFIS-SWE-IG
0.1.0 - ci-build

UFIS-SWE-IG, published by UNICOM. 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/joofio/ufis-swe-ig/ and changes regularly. See the Directory of published versions

Example Bundle: Herceptin-150mg-Powder-SE-IS-MPD-BBDL

Herceptin®

MPID: SE-100007814-00015488
EURDID: 3010

Full name: Herceptin®

- Invented name part: Herceptin® 150 mg Pulver till konc. till infusionsvätska, lösning

- Strength part: 150 mg

- Pharmaceutical dose form part: Pulver till konc. till infusionsvätska, lösning

Name usage: Swedish (Kingdom of Sweden)

Authorised dose form: Powder for concentrate for solution for infusion

Legal status of supply: Medicinal product subject to medical prescription

Domain: Human use

Resource status: Current

Product classification:

  • 100000093533 L01FD01
  • 100000155059 Centralised procedure
  • 100000160967 Concerned Member State

Marketing Authorisation 1 of 1

Authorisation number: 15488

Region: Kingdom of Sweden

Marketing authorisation holder: Roche Registration GmbH

Identifier:

  • LOC-100010587

Status: Valid (2000-08-28)

Package 1 of 1

PCID:

Description:
Injektionsflaska, 1 x 150 mg

Marketing status:

  • Kingdom of Sweden: Marketed

Pack size:

  • 1 Vial

Package: 1 Box (Cardboard)

Containing:

Package: 1 Vial (Glass type I) (Rubber)

Containing: 150 millilitre(s)

Manufactured Item

Dose form: Powder for concentrate for solution for infusion

Unit of presentation: Vial

Ingredient

Role: Active

Substance: Trastuzumab

Presentation strength: 150 milligram(s) / 1 unit(s)

Reference strength:
Trastuzumab 150 milligram(s) / 1 unit(s)

Ingredient

Role: Excipient

Substance: Histidine

Ingredient

Role: Excipient

Substance: Histidine hydrochloride monohydrate

Ingredient

Role: Excipient

Substance: Polysorbate 20

Ingredient

Role: Excipient

Substance: Trehalose dihydrate

Administrable Product (1 of 1)

Dose form: Solution for infusion

Unit of presentation:

Route of administration:

  • Intravenous use

Ingredients:

Ingredient

Role: Active

Substance: Trastuzumab

Presentation strength: 150 milligram(s) / 1 unit(s)

Reference strength:
Trastuzumab 150 milligram(s) / 1 unit(s)

Ingredient

Role: Excipient

Substance: Histidine

Ingredient

Role: Excipient

Substance: Histidine hydrochloride monohydrate

Ingredient

Role: Excipient

Substance: Polysorbate 20

Ingredient

Role: Excipient

Substance: Trehalose dihydrate