Tritanrix HB H-W-3838

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Name of the medicinal product

Tritanrix HB

Opinion holderGlaxoSmithKline Biologicals S.A.
Active substanceBordetella pertussis (inactivated) / diphtheria toxoid / hepatitis B surface antigen / tetanus toxoid
International non-proprietary name or common namediphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Pharmacotherapeutic groupVaccines
ATC codeJ07CA05
Therapeutic indicationActive immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from 6 weeks onwards
Orphan-medicinal-product designation dateNot applicable

 

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Document(s) Language Status First published Last updated Effective Date
Trintanrix HB: Summary for the public (English only)   2014-03-14    
Trintanrix HB: All authorised presentations (English only)   2014-03-14    
Trintanrix HB: Public Assessment Report (English only) adopted 2014-03-14    
Trintanrix HB: Risk-management-plan summary (English only)   2014-03-14    
CHMP summary of positive opinion for Tritanrix HB (English only) adopted 2013-12-20    

Product Information* 19/12/2013 Tritanrix HB-H-C-W-3838

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Document(s) Language Status First published Last updated Effective Date
Trintanrix HB: Product information (English only)   2014-03-14    

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*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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