Rotashield (rotavirus vaccine)
- Region
- 🇪🇺 EU
- Active substance
- rotavirus vaccine
- Company
- Wyeth Lederle Vaccines S.A.
- Status
- Withdrawn
- Therapeutic area
- Immunization; Rotavirus Infections
- EU approval
- Fri 07 May 1999
- Application
- EMEA/H/C/000192
- ATC
- J07BH
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Rotarix Authorised · GlaxoSmithKline Biologicals S.A.
- 🇪🇺 RotaTeq Authorised · Merck Sharp & Dohme B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.