Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: RotaShield
Auth. number : EU/1/99/105
Active substance : Rotavirus vaccine
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07B - Viral vaccines
Chemical subgroup: J07BH - Rota virus diarrhea vaccines
Chemical substance: J07BH01 - rota virus, live attenuated
(See WHO ATC Index)
Indication: Active immunisation of infants aged 6 weeks to 30 weeks for prevention of severe clinical manifestations of gastro-enteritis caused by rotavisus serotypes 1, 2, 3 and 4 of group A
Marketing Authorisation Holder: Wyeth-Lederle Vaccines S.A.
rue du Bosquet 15, 1348 Louvain-la-Neuve, Belgique
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
14/05/1999 Centralised - Authorisation EMEA/H/C/192 (1999)1256 of 07/05/1999
02/11/1999 Centralised - Notification EMEA/H/C/192/N/1 (1999)3518 of 29/10/1999
24/01/2001 Centralised - Withdrawal (2001)84 of 22/01/2001