UnicomIG
0.1.0 - ci-build

UnicomIG, 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/hl7-eu/unicom-ig/ and changes regularly. See the Directory of published versions

Example Bundle: 013-LantusSolostar-EE-FullProduct

Lantus SoloStar 100 ühikut/ml süstelahus pen-süstlis

MPID: EE-100000869-3157

Full name: Lantus SoloStar 100 ühikut/ml süstelahus pen-süstlis

- Invented name part: Lantus Solostar

- Strength part: 100 ühikut/ml

- Pharmaceutical dose form part: süstelahus pen-süstlis

Name usage: Estonian (Republic of Estonia)

Authorised dose form: Solution for injection in pre-filled pen

Legal status of supply: Medicinal product subject to medical prescription

Domain: Human use

Resource status: Current

Product classification:

  • 100000094023 insulin glargine
  • A10AE04 insulin glargine

Marketing Authorisation 1 of 1

Authorisation number: EU/1/00/134

Region: European Union

Marketing authorisation holder: Sanofi-Aventis Deutschland GmbH

Identifier:

  • LOC-100000869
  • ORG-100001175

Status: Valid - Renewed/Varied (2022-06-28)

Package 1 of 1

PCID: EE-100000869-3157-1265778

Description:
Lantus SoloStar 100 ühikut/ml süstelahus pen-süstlis. I tüüpi värvitust klaasist kolbampull musta värvi kolvi (broombutüülkumm), äärikkattega (alumiinium) ja korgiga (broombutüülkumm või polüisopreenlaminaat ja broombutüülkumm); sisaldab 3 ml süstelahust. Kolbampull on paigaldatud mittetäidetavasse pen-süstlisse. Nõelad ei sisaldu pakendis. Pakendis on 5 pen-süstlit.

Marketing status:

  • Republic of Estonia: Marketed

Pack size:

  • 5 Pen

Package: 1 Box (Cardboard)

Containing:

Package: 5 Pre-filled pen

Containing: 3 millilitre(s)

Manufactured Item

Dose form: Solution for injection

Unit of presentation: Pen

Ingredient

Role: Active

Substance: Insulin glargine

Concentration strength: 100 unit(s) / 1 millilitre(s)

Administrable Product (1 of 1)

Dose form: Solution for injection

Unit of presentation: Pen

Route of administration:

  • Subcutaneous use

Ingredients:

Ingredient

Role: Active

Substance: Insulin glargine

Concentration strength: 100 unit(s) / 1 millilitre(s)