PROTELOS / OSSEOR: European Committee for Pharmacovigilance Recommendation

27/01/2014

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, PRAC considers that the benefit-risk ratio of Protelos/Osseor® is no longer favorable. PRAC already give this recommendation to the CHMP, which held a meeting last week.

In this meeting we had an opportunity to present extend data to the CHMP during an oral explanation. No final opinion has been made at this moment by CHMP. The PRAC recommendation is still under consideration. However, the CHMP requested for detailed risk minimization measures that could be implemented in case Protelos marketing authorization is not suspended.

The CHMP will analyze all these measures and is expected to give its opinion during its next meeting in the week of February 17th to 20th.

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.

 
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