Hepacare
Withdrawn
This medicine's authorisation has been withdrawn
hepatitis B surface antigens recombinant (S, pre-S1, pre-S2) adsorbed on aluminium hydroxide [produced on genetically engineered murine (C127I) cells]
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 4 August 2000 the European Commission granted a marketing authorisation for the whole European Union to Medeva Pharma Limited, now known as Celltech Pharmaceuticals Ltd., for Hepacare (triple antigen hepatitis B recombinant vaccine), indicated for active immunisation against hepatitis B virus infection in non-immune adults (≥18 years).
Hepacare was not marketed anywhere in the world. On 23 August 2002 the Marketing Authorisation Holder notified the European Commission of its decision to voluntarily withdraw the marketing authorisation for Hepacare for commercial reasons. Alternatives are available in Europe, either as mono-component or combined vaccines.
On 23 October 2002 the European Commission adopted the decision withdrawing the marketing authorisation for the medicinal product for human use Hepacare. Pursuant to this decision the European Public Assessment Report for Hepacare has been removed from this website.
Product information
23/10/2002
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Hepacare
- Active substance
- hepatitis B surface antigens recombinant (S, pre-S1, pre-S2) adsorbed on aluminium hydroxide [produced on genetically engineered murine (C127I) cells]
- International non-proprietary name (INN) or common name
- hepatitis B surface antigens recombinant (S, pre-S1, pre-S2) adsorbed on aluminium hydroxide [produced on genetically engineered murine (C127I) cells]
- Therapeutic area (MeSH)
- Hepatitis B
- Immunization
- Anatomical therapeutic chemical (ATC) code
- J07BC
Pharmacotherapeutic group
VaccinesTherapeutic indication
This vaccine is indicated for active immunisation against hepatitis B virus infection in non-immune adults (>=18 years). The specific at risk categories to be immunised are to be determined on the basis of official recommendations.
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