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EMEA European Medicine

CHO Chinese hamster ovary EMEA European Medicines Agency... [Pg.581]

Food and Drug Administration) and EMEA (European Medicine Evaluation Agency) granted an approval for the use of bortezomib for the treatment of relapsed multiple myeloma. At present, several phase 11 and phase 111 trials in hematological malignancies and solid tumors are ongoing. PS-519 that focuses on inflammation, reperfusion injury and ischemia is currently under evaluation for the indication of acute stroke. ... [Pg.89]

EMEA. European Medicines Agency. Note for guidance on repeated dose toxicity (CPMP/SWP/1042/99), 2000. Available at http //www.emea.en.int/pdfs/hnman/swp/ 104299en.pdf... [Pg.121]

EMEA (European Medicines Agency, Committee for Human Medicinal Products). Guideline on the need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications (Draft). 2005. EMEA/CHMP/SWP/169215/ 2005. [Pg.293]

S., Patel, Hasmukh B., Powers, Roslyn F., and Yu, Lawrence, Pharmaceutical impurities regulatory perspective for abbreviated new drug apphcations. Advanced Drug Delivery Reviews, 59, 64—72, 2007. Guidance issued by the EMEA (European Medicines Agency, Evaluation of Medicines for Human Use, London, June 23, 2004. See also Reference 6. [Pg.22]

NDA-New drug application ANDA-Abbreviated new drug application CV-cardiovascular PPAR-Peroxisome Proliferator Activator Receptor MMV-Medicines for Malaria Venture GAVI-Global Alliance for Vaccines and Immunization EMEA-European Medicinal Evaluation Agency... [Pg.167]

EMEA (European Medicine Concept Paper on the Development of a Released Mar... [Pg.42]

EMEA (European Medicine Points To Consider Quality Aspects of Issued Mar 13,... [Pg.42]

EMEA (European Medicines Agency). Final position paper on the allergenic potency of herbal medicinal products containing soya or peanut proteins. EA/HMPWP/37/04, London, 11 June 2004. [Pg.1024]

EMEA - European Medicines Agency (2005) Public statement on the use of herbal medicinal products containing pulegone and menthofuran. Doc Ref EMEA/HMPC/138386/2005... [Pg.3006]

EMEA - European Medicines Agency (2009) Assessment report on Artemisia absinthium L. Herba. Doc. Ref. EMEA/HMPC/234444/2008... [Pg.3007]

In France, the AMM are delivered by the Agence Fran aise de Securite Sanitaire des Produits de Sante (AFSSAPS). At the European level, the authorizations are delivered by EMeA (European Medicines Agency, or the European Agency of Evaluation of the Drugs), and in the USA,... [Pg.45]


See other pages where EMEA European Medicine is mentioned: [Pg.210]    [Pg.77]    [Pg.115]    [Pg.446]    [Pg.294]    [Pg.89]    [Pg.200]    [Pg.21]    [Pg.350]    [Pg.352]    [Pg.349]    [Pg.976]    [Pg.212]    [Pg.443]    [Pg.531]    [Pg.455]    [Pg.1557]    [Pg.332]    [Pg.364]    [Pg.372]    [Pg.187]    [Pg.6]   


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EMEA

European Medicinal Evaluation Agency EMEA)

European Medicines

European Medicines Agency (EMEA centralized procedure

European Medicines Agency EMEA)

European Medicines Evaluation Agency (EMEA

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