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COMMITTEE FOR MEDICINAL PRODUCTS FOR …

COMMITTEE FOR MEDICINAL PRODUCTS FOR

www.ema.europa.eu

Page 5/45 ©EMEA 2006 factors for any medicine administered orally; additionally, rate of dissolution and the ability to keep medication at the site of absorption will be important for buccal or sublingual administration.

  Product, Committees, Medicinal, Committee for medicinal products for

COMMITTEE FOR MEDICINAL PRODUCTS FOR …

COMMITTEE FOR MEDICINAL PRODUCTS FOR

www.ema.europa.eu

Revision History . The guideline EMEA/CVMP/846/99 was revised to be brought in line with the requirements of the Note for Guidance on Stability Testing of New Veterinary Drug Substances and Medicinal Products

  Product, Veterinary, Committees, Medicinal, Medicinal products, Committee for medicinal products for

COMMITTEE FOR MEDICINAL PRODUCTS FOR …

COMMITTEE FOR MEDICINAL PRODUCTS FOR

www.ema.europa.eu

©EMEA 2006 3/8 EXECUTIVE SUMMARY The toxicological assessment of genotoxic impurities and the determination of acceptable limits for such impurities in active substances is a difficult issue and not addressed in sufficient detail in the

  Product, Committees, Medicinal, Committee for medicinal products for

COMMITTEE FOR MEDICINAL PRODUCTS FOR …

COMMITTEE FOR MEDICINAL PRODUCTS FOR

www.ema.europa.eu

European Medicines Agency Inspections 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 95

  Product, European, Committees, Medicinal, Committee for medicinal products for

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