Basic Information
RotaTeq
Regulatory Information
EMEA/H/C/000669
Authorised
June 26, 2006
April 27, 2006
38
April 25, 2025
Company Information
the netherlands
Waarderweg 39 2031 BN Haarlem
Merck Sharp & Dohme BV
Active Substances Detail
rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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.
Overview Summary
This is a summary of the European public assessment report (EPAR) for RotaTeq. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for RotaTeq.