http://www.emea.europa.eu/whatsnewp.htm - Last Checked: 11/20/09 16:57:20 - Added: 05/10/07 10:42:38
23/10/09 Press Release - Arpida A/S withdraws its marketing authorisation application for Mersarex (iclaprim) Press Office 23/10/09 Monthly report from the PDCO October meeting Press Office 23/10/09 CHMP revised EPAR on: RebetolINN: ribavirinRev. 18 EPARs 23/10/09 CVMP revised EPAR on: Nobilis Influenza H5N2Rev. 4 Veterinary Medicines EPARs 23/10/09 Concept paper on revision of Chapter 7 of the GMP Guide concerning "outsourced GMP activities" Inspections Good Manufacturing Practice 23/10/09 Press Release from the CHMP October meeting Press Office 23/10/09 Updated temporary treatment recommendations for Cerezyme Human Medicines EPARs 23/10/09 CHMP summaries of positive opinion for: - Sildenafil ratiopharmINN: sildenafil - ZenasINN: amifampridine - ScintimunINN: besilesomab - Leflunomide WinthropINN: leflunomide Human Medicines Summay of Opinion 23/10/09 CHMP post-authorisation summary of positive opinion for: - XeristarINN: duloxetine hydrochloride - PritorINN: telmisartan - KinzalmonoINN: telmisartan - MicardisINN: telmisartan - AdcircaINN: tadalafil - CymbaltaINN: duloxetine hydrochloride - AngioxNN: bivalirudin Human Medicines Summay of Opinion 23/10/09 CHMP Opinions on Referrals: - Q&A on the referral for Teicoplanin Hospira powder and solvent for injection containing 200 or 400 mg teicoplanin - Q&A on the referral for Myderison tablets containing tolperisone hydrochloride 50 and 150 mg - Q&A on the withdrawal of the marketing authorisation for medicines containing dextropropoxyphene Human Medicines Referrals - Referral Opinions Updated public summary of positive opinion for orphan designation of: - Human Medicines 23 October, 2009
CHMP revised EPAR on:
RebetolINN: ribavirinRev. 18
CVMP revised EPAR on:
Nobilis Influenza H5N2Rev. 4
CHMP summaries of positive opinion for:
- Sildenafil ratiopharmINN: sildenafil - ZenasINN: amifampridine - ScintimunINN: besilesomab - Leflunomide WinthropINN: leflunomide
CHMP post-authorisation summary of positive opinion for:
- XeristarINN: duloxetine hydrochloride - PritorINN: telmisartan - KinzalmonoINN: telmisartan - MicardisINN: telmisartan - AdcircaINN: tadalafil - CymbaltaINN: duloxetine hydrochloride - AngioxNN: bivalirudin
CHMP Opinions on Referrals: - Q&A on the referral for Teicoplanin Hospira powder and solvent for injection containing 200 or 400 mg teicoplanin - Q&A on the referral for Myderison tablets containing tolperisone hydrochloride 50 and 150 mg - Q&A on the withdrawal of the marketing authorisation for medicines containing dextropropoxyphene
Updated public summary of positive opinion for orphan designation of:
-
23 October, 2009
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