Pharmacovigilance Risk Assessment Committee meeting highlights
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) gave recommendations on two medicines and started one new safety review at its September 2013 meeting.
Firstly, the PRAC recommended that medicines called “short-acting beta-agonists” should no longer be used in oral or suppository forms in obstetric indications (for the care of pregnant women), such as for suppressing premature labor or excessive labor contractions. However, injectable forms of these medicines should remain authorised for short-term obstetric use under specific conditions.
Action on Numeta G13%E and Numeta G16%E
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