Monday, 29 September 2008

Drug approvals for European market

Committee for Medicinal Products for Human Use (CHMP) recommended to grant a marketing authorisation for the following medicinal products:

1. Vildagliptin/metformin hydrochloride (Zomarist) 50 mg+850 mg and 50 mg+1000 mg, film-coated tablet: (Novartis )
2. Zypadhera, 210 mg, 300 mg, 405 mg powder for suspension for injection intended for treatment of schizophrenia: (Eli Lilly )

3. Xiliarx 50 mg tablets intended for treatment of type 2 diabetes mellitus:(Novartis Europharm Ltd.)
4. Irbesartan 75 mg , 150 mg and 300 mg film-coated tablets :(Krka)
5. Brinzolamide and Timolol (Azarga) 10 mg/ml / 5 mg/ml Eye drops, suspension intended the treatment of elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension: (Alcon)
6. Tetrahydrobiopterin (Kuvan), 100 mg, soluble tablets intended for the treatment of hyperphenylalaninemia (HPA):(Merck KGaA)

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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