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If you want to find news, press releases, public statements and information on meetings and events then this section of the website contains all you need. You can also review the What's New page which is a scrolling feed of all new information published on the website daily.
Latest News
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17/05/2013
European Medicines Agency reiterates PRAC recommendation for Diane 35 and generics
Following the conclusion of the Pharmacovigilance Risk Assessment Committee (PRAC) that the benefits of Diane 35 and its generics outweigh the risks in a specific patient group, the French National Agency for the Safety of Medicine and Health Products (ANSM) unexpectedly announced today the decision to suspend the marketing authorisations of these medicines in France. ... Read more
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17/05/2013
International Clinical Trials Day: 20 May 2013
The European Medicines Agency supports International Clinical Trials Day, which is taking place on Monday 20 May 2013. ... Read more
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17/05/2013
Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 14-16 May 2013
The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for ProZinc (insulin human) from Boehringer Ingelheim Vetmedica GmbH, for the treatment of diabetes mellitus in cats to achieve reduction of hyperglycaemia and improvement of associated clinical signs. ... Read more
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17/05/2013
European Medicines Agency recommends first vaccine for foot-and-mouth disease for authorisation at EU level
The European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has recommended the marketing authorisation for Aftovaxpur DOE for use in response to outbreaks of foot-and-mouth disease (FMD). ... Read more
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17/05/2013
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2013
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefits of Diane 35 (cyproterone acetate 2 mg, ethinylestradiol 35 micrograms) and its generics outweigh the risks in a specific patient group, provided that several measures are taken to minimise the risk of thromboembolism, including new contraindications and warnings. ... Read more
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17/05/2013
Benefits of Diane 35 and generics outweigh risks in specific patient group
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics outweigh the risks, provided that several measures are taken to minimise the risk of thromboembolism (formation of blood clots in the veins and arteries). ... Read more
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16/05/2013
European Medicines Agency closed 20 May 2013
The European Medicines Agency will be closed from 6.30pm on Friday 17 May until 7.30am on Tuesday 21 May 2013. ... Read more
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16/05/2013
World Hypertension Day: 17 May 2013
The European Medicines Agency supports World Hypertension Day, which is taking place on Friday 17 May 2013. ... Read more
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08/05/2013
European Medicines Agency simplifies processing of fee reductions for orphan medicines
The European Medicines Agency has cancelled the procedure by which sponsors of medicines with an orphan designation need to inform the Agency of their intention to submit an application in order to be eligible for a fee reduction. ... Read more
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08/05/2013
Comments invited on draft revised guideline on biosimilars
The European Medicines Agency (EMA) has revised its overarching guideline on similar biological medicines and published a draft for public consultation. ... Read more
Latest Events
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11/07/2012 - 13/07/2012 : CAT
Committee for Advanced Therapies (CAT): 11-13 July 2012
The Committee for Advanced Therapies (CAT) is the committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines. It does not currently publish the minutes or agendas of its meetings. It does publish a meeting report after each meeting.
Latest Human Alerts
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17/12/2012
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19/11/2012
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23/10/2012
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19/10/2012
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24/08/2012
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20/07/2012
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22/06/2012
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22/06/2012
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22/06/2012
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25/05/2012