European Medicines Agency Recommends Approval of Hexyon 6-in-1 Paediatric Vaccine

Upon approval Hexyon will be the only fully liquid, ready-to-use 6-in-1 paediatric vaccine in Europe

Lyon, 22 February 2013 – Sanofi Pasteur MSD, the joint venture between MSD and Sanofi Pasteur in Europe, announced today that their innovative 6-in-1 paediatric vaccine Hexyon has been recommended for marketing authorisation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The new hexavalent vaccine, developed by Sanofi Pasteur, will be commercialised in Europe under two brands names – in Western Europe* by Sanofi Pasteur MSD under the brand name Hexyon and in Eastern Europe by Sanofi Pasteur under the brand name Hexacima.

Hexyon is the only fully liquid, ready-to-use 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough), Hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.

“We welcome the CHMP’s positive recommendation,” said Jean-Paul Kress, President of Sanofi Pasteur MSD.  “It validates the clinical data supporting the vaccine’s effective and safe use for infants.  Furthermore, its unique ready-to-use formulation will provide healthcare professionals with a simpler, more convenient vaccination process.”

Hexyon’s formulation does not require reconstitution prior to administration, so improving convenience.  Hexyon will be indicated for primary and booster vaccination of infants from six weeks to 24 months of age in accordance with official recommendations.

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* France, Germany, UK, Spain, Italy, Belgium, Netherlands, Austria, Portugal, Switzerland, Norway, Sweden, Denmark, Finland, Ireland, Greece, Iceland, Luxembourg, Liechtenstein

 

About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between Sanofi Pasteur, the vaccine division of Sanofi, and Merck, known as MSD outside the USA and Canada. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of Sanofi Pasteur and Merck to focus on the development of new vaccines for Europe to improve the acceptability, efficacy and tolerability of vaccination.

 

For further information please contact:

Caroline ASHE

Senior Director External Communications Europe
Sanofi Pasteur MSD
Tel :   +33 4 37 28 4040
Mob :+33 6 33 46 1365
CAshe@spmsd.com

 

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European Medicines Agency Recommends Approval of Hexyon 6-in-1 Paediatric Vaccine