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French Agency for Food, Environmental and Occupational Health & Safety

Suspension of the Marketing Authorisation for the veterinary vaccine HIPRABOVIS PNEUMOS

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News of 15/04/2011

15 April 2011

Through the French Agency for Veterinary Medicinal Products (ANMV), ANSES has recently received reports of several cases of hypersensitivity reaction in cattle vaccinated with HIPRABOVIS PNEUMOS. This vaccine, for which Laboratorios HIPRA have a Marketing Authorisation (MA), is currently the only drug sold in France which combines the two valences against Mannhaemia haemolytica (biotype A, serotype A1) and Histophilus somni (Bailie).

These cases of post-vaccinal anaphylaxis exhibit classic as well as acute symptoms (congestion, respiratory distress, etc.) that have resulted in the death of several animals. In all, reactions have been reported in 69 cattle, with 18 fatal cases.
The vaccine is sold in several other European Union member states, and similar cases have been recorded in Belgium and Italy.
Considering the abnormally high incidence of these cases of shock (one case for 500 animals vaccinated), the Agency has decided to suspend the MA for this vaccine further to the withdrawal of the product from sale by Laboratorios HIPRA.
The suspension will initially apply for one year and will be re-examined in the light of the results expected from complementary investigations carried out by Laboratorios HIPRA.

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The French Agency for Veterinary Medicinal Products (ANMV), under the authority of the Director General of ANSES, carries out the missions assigned to the latter in the field of veterinary pharmacy. For this purpose it is empowered to make scientific evaluations, carry out inspections and make decisions. Among other tasks, it is responsible for authorisations concerning veterinary medicinal products. It organises the inspection of veterinary pharmaceutical companies and the pharmacovigilance system. It also monitors and controls the quality of medicinal products.
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