Rotarix

RSS

rotavirus vaccine, live, attenuated

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 30/10/2018

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, attenuated
Therapeutic area (MeSH)
  • Immunization
  • Rotavirus Infections
Anatomical therapeutic chemical (ATC) code
J07BH01
Publication details
Marketing-authorisation holder
GlaxoSmithKline Biologicals S.A.
Revision
28
Date of issue of marketing authorisation valid throughout the European Union
20/02/2006
Contact address
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

25/07/2018 Rotarix - EMEA/H/C/000639 - II/0106/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

How useful was this page?

Add your rating