Rotashield

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Withdrawn

This medicine's authorisation has been withdrawn

rotavirus vaccine
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 7 May 1999, the European Commission issued a Marketing Authorisation valid throughout the European Union for the medicinal product Rotashield, which contains one rhesus rotavirus serotype (serotype 3) and three reassortant rotavirus serotypes derived from rhesus and human strains (serotypes 1, 2 and 4). The pharmaceutical company responsible for this medicinal product is Wyeth-Lederle Vaccines S.A.

On 2 November 2000, the Marketing Authorisation holder notified the European Commission of its decision to withdraw the Marketing Authorisation for Rotashield.

On 22 January 2001, the European Commission adopted the decision withdrawing the Marketing Authorisation for the medicinal product for human use “Rotashield – Rotavirus vaccine”. Pursuant to this decision the European Public Assessment Report for Rotashield has been removed from this website.

For information, it should be noted that the product has never been marketed within the European Economic Area.

Product information

31/12/2009
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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
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
Withdrawal of marketing authorisation
22/01/2001
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