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Date: 2012-06-24

Type of information: Granting of a Market Authorisation in the EU

Product name: Hexaxim®

Compound: diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA),poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) combined bacterial and viral vaccine

Therapeutic area: Infectious diseases

Action mechanism:

vaccine. Hexaxim® is a hexavalent (6 in ) paediatric combination vaccine. The active substances in Hexaxim® are diphtheria toxoid (D), tetanus toxoid (T), two-component acellular pertussis (pertussis toxoid (PTxd) and filamentous haemagglutinin (FHA)), inactivated poliomyelitis virus types 1,2 and 3 (IPV), Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein (PRP-T) and hepatitis B surface antigen (HBsAg).

Company: Sanofi Pasteur (France)

Disease:

primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b

Latest news:

* On 21 June 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a scientific opinion in accordance with Article 58 of Regulation (EC) No 726/2004, for the medicinal product Hexaxim®, 0.5 ml, suspension for injection intended for primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b.
The benefits of Hexaxim® are its ability to protect infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b. The vaccine can be used as primary or a booster vaccination. It is given as three doses at least four weeks apart in accordance with official recommendations.
The most common side effects are pain, swelling, induration and erythema at the injection site, vomiting, irritability, somnolence, anorexia, pyrexia, abnormal (prolonged) crying, and diarrhoea.
A pharmacovigilance plan for Hexaxim® will be implemented as part of the post-opinion commitments.

This medicinal product Hexaxim® 0.5 ml suspension for injection is exclusively intended for markets outside the European Union. The EMA scientific opinion is based on the review of a dossier submitted by Sanofi Pasteur through the “Article 58” procedure. The EMA assessment was conducted with the participation of experts from the World Health Organization (WHO) according to the same quality, safety and efficacy criteria as vaccines authorized for the European Union. Many countries in Latin America, Africa, the Middle East and Asia grant market authorization based on the EMA scientific opinion.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE: 2012-06-21

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes