PROTELOS / OSSEOR: European Committee for Pharmacovigilance Recommendation

10/01/2014

Suresnes, 10 January 2014

Servier would like to inform healthcare professionals that, following the first stage of the review, the PRAC (European Committee for Pharmacovigilance) has made a recommendation to the CHMP (Committee for Medicinal Products for Human Use) for the suspension of the marketing authorization for Protelos/Osseor® (strontium ranelate) indicated in the treatment of severe osteoporosis.

In April 2013, due to an excess in newly identified cardiovascular risk, the European Medicines Agency (EMA) restricted conditions of use of Protelos/Osseor®, pending a full review of its benefits and risks.

Following this review, the PRAC considers that the benefit-risk ratio of Protelos/Osseor® is no longer favorable. The PRAC will refer its recommendation to the CHMP which, after a hearing and discussion, will define its opinion at its next meeting held on January 20th to 23rd, 2014.

Servier is informing all health agencies in countries where Protelos/Osseor® is registered of the pending proceedings. As soon as this procedure of re-evaluation is finalized, Servier will send detailed information to healthcare professionals specifying the CHMP decision and the practical implications for the management of their patients.