European Medicines Agency Recommends Approval Of Hexyon 6-In-1 Paediatric Vaccine

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European Medicines Agency Recommends Approval Of Hexyon 6-In-1 Paediatric Vaccine

Main Category: Pediatrics / Children's Health
Also Included In: Immune System / Vaccines
Article Date: 01 Mar 2013

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

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 efficacy in infants. As the only fully liquid, ready-to-use heaxavalent paediatric vaccine, it makes vaccination simple and convenient for healthcare professionals."

Hexyon's formulation does not require reconstitution prior to administration. Hexyon will be licensed for primary and booster vaccination of infants from six weeks to 24 months of age for use in accordance with official recommendations.

Hexyon is currently not marketed in the UK.

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

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