Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Hepacare
Auth. number : EU/1/00/136
Active substance : Triple antigen hepatitis B vaccine (recombinant)
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07B - Viral vaccines
Chemical subgroup: J07BC - Hepatitis vaccines
Chemical substance: J07BC01 - hepatitis b, purified antigen
(See WHO ATC Index)
Indication: This vaccine is indicated for active immunisation against hepatitis B virus infection in non-immune adults
Marketing Authorisation Holder: Medeva Pharma Limited
Regent Park, Kingston Road, Leatherhead, Surrey KT22 7PQ, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
07/08/2000 Centralised - Authorisation EMEA/H/C/261 (2000)2373 of 04/08/2000
09/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/261/II/1
30/10/2002 Centralised - Withdrawal (2002)4288 of 23/10/2002