Tritanrix HB: Opinion on medicine for use outside EU
diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Table of contents
Opinion on medicine for use outside the European Union
Withdrawn opinion
Overview
The opinion for Tritanrix HB for use outside the European Union has been withdrawn at the request of the opinion holder.
Opinion details
Product details | |
---|---|
Name of medicinal product |
Tritanrix HB
|
Agency opinion number |
H-W-3838
|
Opinion status |
Withdrawn opinion
|
Active substance |
|
International non-proprietary name (INN) or common name |
diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
J07CA05
|
Publication details | |
---|---|
Opinion holder |
GlaxoSmithKline Biologicals S.A. |
Date of opinion |
19/12/2013
|
Product information
19/12/2013 Tritanrix HB H-C-W-3838
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturer responsible for batch release
- Annex IIB - Recommendations to the opinion holder - conditions of use
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Pharmacotherapeutic group
Vaccines
Therapeutic indication
Therapeutic indication
Active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from 6 weeks onwards.
Assessment history
-
List item
Tritanrix HB : Withdrawal of the Article 58 scientific opinion - Public statement (PDF/66.72 KB)
First published: 01/08/2019
EMA/370562/2019 -
List item
Tritanrix HB : Public Assessment Report (PDF/1.66 MB)
Adopted
First published: 14/03/2014
EMA/CHMP/49887/2014 -
List item
Tritanrix HB : All presentations (PDF/943.16 KB)
First published: 14/03/2014 -
List item
CHMP summary of positive opinion for Tritanrix HB (PDF/974.7 KB)
Adopted
First published: 20/12/2013
EMA/CHMP/749396/2013