RotaTeq
rotavirus vaccine, live
Table of contents
Overview
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.
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List item
RotaTeq : EPAR - Summary for the public (PDF/82.57 KB)
First published: 03/06/2008
Last updated: 01/03/2016 -
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List item
RotaTeq : EPAR - Risk-management-plan summary (PDF/82.25 KB)
First published: 04/06/2021
Authorisation details
Product details | |
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Name |
RotaTeq
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Agency product number |
EMEA/H/C/000669
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Active substance |
rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1
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International non-proprietary name (INN) or common name |
rotavirus vaccine, live
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
J07BH02
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Publication details | |
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Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
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Revision |
36
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Date of issue of marketing authorisation valid throughout the European Union |
26/06/2006
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Contact address |
Waarderweg 39 |
Product information
22/03/2023 RotaTeq - EMEA/H/C/000669 - N/0094
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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Vaccines
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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.