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Published on 18 March 2011

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CHMP announces four new drug positive opinions

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The Committee for Medicinal Products for Human use (CHMP) announced that it has adopted positive opinions recommending the granting of marketing authorisations for four new medicines at its meeting this week.

The Committee, which is responsible for preparing the opinions of the European Medicines Agency, looks favourably at the approval of new treatments for venous thromboemobilsm prvention, postoperative ocular inflammation and contraception.

Among these medicines is Eliquis (apixaban) – a treatment from Bristol-Myers Squibb/Pfizer EEIG, intended for the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery.

The review for Eliquis began on 24 March 2010 with an active review time of 210 days.

Yellox (bromfenax), from Croma-Pharma GmbH, which is intended for the treatment of postoperative ocular inflammation following cataract extraction in adults, has also been given a positive opinion.

The review for Yellox began on 22 July 2009 with an active review time of 210 days.

Zoely and IOA (nomogestrol acetate/oestradiol), from Merck Serono Europe Ltd and N.V. Organon, is the treatment with a positive CMPH opinion intended for contraception.

The Committee gave also a positive opinion for Cinryze (C1 inhibitor, human), an orphan medicine from ViroPharma SPRL, intended for the treatment and prevention of angioedema attacks in patients with C1 inhibitor deficiency. The review for Cinryze began on 24 March 2010 with an active review time of 201 days.

But the CHMP also noted that ViroPharma is considered the same applicant as Sanquin, which holds marketing authorisations in some European Union (EU) Member States for a medicine with the same composition and pharmaceutical form and overlapping indications with Cinryze.

This may preclude the granting of a marketing authorisation for Cinryze.

EMA 2011

 



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