Rotarix (rotavirus vaccine, live)
- Region
- 🇪🇺 EU
- Active substance
- rotavirus vaccine, live
- Company
- GlaxoSmithKline Biologicals S.A.
- Status
- Authorised
- Therapeutic area
- Immunization; Rotavirus Infections
- EU approval
- Tue 21 Feb 2006
- Application
- EMEA/H/C/000639
- ATC
- J07BH01
- Official record
- www.ema.europa.eu
Indication
Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection. The use of Rotarix should be based on official recommendation.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 RotaTeq Authorised · Merck Sharp & Dohme B.V.
- 🇪🇺 Rotashield Withdrawn · Wyeth Lederle Vaccines S.A.
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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.