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: 017-ImovaxPolio-EE-FullProduct

Imovax Polio, süstesuspensioon süstlis

MPID: EE-100010589-1025985

Full name: Imovax Polio, süstesuspensioon süstlis

- Invented name part: Imovax Polio

- Pharmaceutical dose form part: süstesuspensioon süstlis

Name usage: Estonian (Estonia)

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

Legal status of supply: Medicinal product subject to medical prescription

Domain: Human use

Resource status: Current

Product classification:

  • 100000096580 poliomyelitis, trivalent, inactivated, whole virus
  • J07BF03 poliomyelitis, trivalent, inactivated, whole virus

Marketing Authorisation 1 of 1

Authorisation number: 301700

Region: Estonia

Marketing authorisation holder: Sanofi Pasteur

Identifier:

  • LOC-100010589

Status: Valid (2000-02-25)

Package 1 of 1

PCID:

Description:
0,5 ml süstesuspensiooni eeltäidetud süstlas (I tüüpi klaas), mis on varustatud kolbkorgiga (klorobutüülist) – karbis 1 tk.

Marketing status:

  • Estonia: Marketed

Pack size:

  • 1 Pen

Package: 1 Box (Cardboard)

Containing:

Package: 1 Prefilled pen (Glass)

Containing: 1 Pen

Manufactured Item

Dose form: Suspension for injection

Unit of presentation: Pen

Ingredient

Role: Active

Substance: Poliovirus (inactivated) type 1 (Mahoney strain)

Presentation strength: 29 D antigen unit(s) / 0.5 millilitre(s)

Reference strength:
Poliovirus (inactivated) type 1 (Mahoney strain) 29 D antigen unit(s) / 0.5 millilitre(s)

Ingredient

Role: Active

Substance: Poliovirus (inactivated) type 2 (MEF-1 strain)

Presentation strength: 7 D antigen unit(s) / 0.5 millilitre(s)

Reference strength:
Poliovirus (inactivated) type 2 (MEF-1 strain) 7 D antigen unit(s) / 0.5 millilitre(s)

Ingredient

Role: Active

Substance: Poliovirus (inactivated) type 3 (Saukett strain)

Presentation strength: 26 D antigen unit(s) / 0.5 millilitre(s)

Reference strength:
Poliovirus (inactivated) type 3 (Saukett strain) 26 D antigen unit(s) / 0.5 millilitre(s)

Administrable Product (1 of 1)

Dose form: Suspension for injection

Unit of presentation:

Route of administration:

  • Intramuscular use

Ingredients:

Ingredient

Role: Active

Substance: Poliovirus (inactivated) type 1 (Mahoney strain)

Presentation strength: 29 D antigen unit(s) / 0.5 millilitre(s)

Reference strength:
Poliovirus (inactivated) type 1 (Mahoney strain) 29 D antigen unit(s) / 0.5 millilitre(s)

Ingredient

Role: Active

Substance: Poliovirus (inactivated) type 2 (MEF-1 strain)

Presentation strength: 7 D antigen unit(s) / 0.5 millilitre(s)

Reference strength:
Poliovirus (inactivated) type 2 (MEF-1 strain) 7 D antigen unit(s) / 0.5 millilitre(s)

Ingredient

Role: Active

Substance: Poliovirus (inactivated) type 3 (Saukett strain)

Presentation strength: 26 D antigen unit(s) / 0.5 millilitre(s)

Reference strength:
Poliovirus (inactivated) type 3 (Saukett strain) 26 D antigen unit(s) / 0.5 millilitre(s)