RotaTeq (rotavirus vaccine, live)
- Region
- 🇪🇺 EU
- Active substance
- rotavirus vaccine, live
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- Immunization; Rotavirus Infections
- CHMP opinion
- Thu 27 Apr 2006
- EU approval
- Mon 26 Jun 2006
- Application
- EMEA/H/C/000669
- ATC
- J07BH02
- Official record
- www.ema.europa.eu
Indication
RotaTeq is indicated for the active immunisation of infants from the age of six weeks to 32 weeks for prevention of gastroenteritis due to rotavirus infection. RotaTeq is to be used on the basis of official recommendations.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Rotarix Authorised · GlaxoSmithKline Biologicals S.A.
- 🇪🇺 Rotashield Withdrawn · Wyeth Lederle Vaccines S.A.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.