Tritanrix HB H-W-3838
| Name of the medicinal product | Tritanrix HB |
| Opinion holder | GlaxoSmithKline Biologicals S.A. |
| Active substance | Bordetella pertussis (inactivated) / diphtheria toxoid / hepatitis B surface antigen / tetanus toxoid |
| International non-proprietary name or common name | diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed) |
| Pharmacotherapeutic group | Vaccines |
| ATC code | J07CA05 |
| Therapeutic indication | Active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from 6 weeks onwards |
| Orphan-medicinal-product designation date | Not applicable |
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Tritanrix HB: Public statement on the withdrawal of the scientific opinion under Article 58 (PDF/66.72 KB)
First published: 01/08/2019
EMA/370562/2019 -
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Trintanrix HB: Summary for the public (PDF/1017.1 KB)
First published: 14/03/2014
Last updated: 14/03/2014
EMA/809058/2013 -
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Trintanrix HB: All authorised presentations (PDF/943.16 KB)
First published: 14/03/2014
Last updated: 14/03/2014
EMEA/H/C/W/003838 -
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Trintanrix HB: Public Assessment Report (PDF/1.66 MB)
Adopted
First published: 14/03/2014
Last updated: 14/03/2014
EMA/CHMP/49887/2014 -
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Trintanrix HB: Risk-management-plan summary (PDF/1015.12 KB)
First published: 14/03/2014
Last updated: 14/03/2014
EMA/14365/2014 -
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CHMP summary of positive opinion for Tritanrix HB (PDF/974.7 KB)
Adopted
First published: 20/12/2013
Last updated: 20/12/2013
*This document includes:
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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