Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 January 2014

News 10/01/2014

PRAC recommendation on Protelos/Osseor

Following an in-depth review of the medicine, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that Protelos/Osseor should no longer be used to treat osteoporosis.

The PRAC recommendation will now be sent to the Agency's Committee for Medicinal Products for Human Use (CHMP), which is expected to issue the Agency's final opinion at its meeting of 20 to 23 January 2014.

More information on this topic, as well as the full agenda of the PRAC's January meeting, are available in the table below.

Agenda

PDF iconAgenda - PRAC draft agenda of meeting 6-9 January 2014

Recommendation by PRAC

Protelos / Osseor

Article-20 procedure: Protelos / Osseor

PDF iconSummary of PRAC recommendation

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