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Rotashield

Active Substance: rotavirus serotype 1 reassortant, rotavirus serotype 2 reassortant, rotavirus serotype 3 rhesus, rotavirus serotype 4 reassortant
Common Name: rotavirus vaccine, attenuated
ATC Code: J07BH
Marketing Authorisation Holder: Wyeth Lederle Vaccines S.A.
Active Substance: rotavirus serotype 1 reassortant, rotavirus serotype 2 reassortant, rotavirus serotype 3 rhesus, rotavirus serotype 4 reassortant
Status: Withdrawn
Authorisation Date: 1999-05-07
Therapeutic Area: Rotavirus Infections Immunization
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.

The marketing authorisation for Rotashield has been withdrawn at the request of the marketing authorisation holder.

Source: European Medicines Agency

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