Rotarix

RSS

rotavirus vaccine, live

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Rotarix. 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 Rotarix.

This EPAR was last updated on 31/07/2023

Authorisation details

Product details
Name
Rotarix
Agency product number
EMEA/H/C/000639
Active substance
human rotavirus, live attenuated
International non-proprietary name (INN) or common name
rotavirus vaccine, live
Therapeutic area (MeSH)
  • Immunization
  • Rotavirus Infections
Anatomical therapeutic chemical (ATC) code
J07BH01
Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A.
Revision
41
Date of issue of marketing authorisation valid throughout the European Union
21/02/2006
Contact address
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

28/07/2023 Rotarix - EMEA/H/C/000639 - IB/0130

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Select ‘available languages’ to access the language you need.

 

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

Therapeutic 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.

Assessment history

Changes since initial authorisation of medicine

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