Rotashield

RSS

rotavirus vaccine

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Rotashield has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 31/12/2009

Authorisation details

Product details
Name
Rotashield
Agency product number
EMEA/H/C/000192
Active substance
rotavirus serotype 1 reassortant, rotavirus serotype 2 reassortant, rotavirus serotype 3 rhesus, rotavirus serotype 4 reassortant
International non-proprietary name (INN) or common name
rotavirus vaccine
Therapeutic area (MeSH)
  • Immunization
  • Rotavirus Infections
Anatomical therapeutic chemical (ATC) code
J07BH
Publication details
Marketing-authorisation holder
Wyeth Lederle Vaccines S.A.
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
07/05/1999
Contact address
Rue du Bosquet, 15
B-1348 Louvain-la-Neuve
Belgium

Product information

31/12/2009 Rotashield - EMEA/H/C/000192 -

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Vaccines

Therapeutic indication

RotaShield is indicated for active immunisation of infants aged 6 weeks to 30 weeks for prevention of severe clinical manifestations of gastro-enteritis caused by rotavirus serotypes 1, 2, 3 and 4 of group A.

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