rotavirus vaccine, live

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 14/04/2023

Authorisation details

Product details
Agency product number
Active substance
rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1
International non-proprietary name (INN) or common name
rotavirus vaccine, live
Therapeutic area (MeSH)
  • Immunization
  • Rotavirus Infections
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

22/03/2023 RotaTeq - EMEA/H/C/000669 - N/0094

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Vaccines

  • Viral vaccines

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.

Assessment history

Changes since initial authorisation of medicine

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