Rotashield

Withdrawn

This medicine's authorisation has been withdrawn

rotavirus vaccine

Overview

The marketing authorisation for Rotashield has been withdrawn at the request of the marketing authorisation holder.

Product information

31/12/2009

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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:
  Rotashield
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000192
• Marketing authorisation holder:
  Wyeth Lederle Vaccines S.A.

  Rue du Bosquet, 15; B-1348 Louvain-la-Neuve; Belgium

• Marketing authorisation issued:
  07/05/1999