Rotashield
Withdrawn
This medicine's authorisation has been withdrawn
rotavirus vaccine
Medicine
Human
Withdrawn
- 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
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
VaccinesTherapeutic 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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