Rotashield
Withdrawn
This medicine's authorisation has been withdrawn
rotavirus vaccine
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Rotashield has been withdrawn at the request of the marketing authorisation holder.
Product information
31/12/2009
This medicine’s product information is available in all official EU languages.
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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
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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