Committee for Medicinal Products for Human Use

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Committee for Medicinal Products for Human Use

The European Medicines Agency's committee, which is responsible for elaborating the agency's opinions on all issues regarding medicinal products for human use.
References in periodicals archive ?
Reference is made in particular to plans for the development of additional clinical data in response to the determination of the Committee for Proprietary Medicinal Products (CPMP) and the Company's expectations regarding the impact of the decision on financial results.
Eli Lilly and Company (NYSE:LLY) announced today that the European Committee for Proprietary Medicinal Products (CPMP) has issued a positive opinion for a new indication for Zyprexa(R) (olanzapine).
Nasdaq:GILD) today announced that the European Union's Committee for Proprietary Medicinal Products (CPMP), the scientific committee of the European Medicines Evaluation Agency (EMEA), has recommended granting Marketing Authorisation for the company's new once-daily medication for HIV, Emtriva(TM) (emtricitabine, 200 mg hard capsule and 10 mg/mL oral solution), in the 15 member states of the European Union.
Nasdaq:ILXO) announced today that the European Committee for Proprietary Medicinal Products (CPMP) has granted a positive opinion on the addition of survival data to the label for the drug MabCampath(R) (alemtuzumab) in the European Union.
This decision follows a positive opinion adopted in December 2002 by the European Committee for Proprietary Medicinal Products (CPMP).
Schering-Plough Corporation (NYSE: SGP) today announced that the Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has issued a positive opinion recommending approval of the nonsedating antihistamine desloratadine 5 mg as a once-daily treatment for seasonal allergic rhinitis (SAR).
This action represents the implementation of an agreement that was reached late last year by the Committee for Proprietary Medicinal Products (CPMP), to revise and harmonize the indications for all calcitonin products approved in the EU.
The application for Rapamune(R) (sirolimus), Wyeth-Ayerst's immunosuppressant agent for the prevention of organ rejection following renal transplantation, has received a negative opinion from the Committee for Proprietary Medicinal Products (CPMP), the scientific advisory body of the European Medicines Evaluation Agency (EMEA).
Schering-Plough Corporation (NYSE: SGP) today announced that the European Union's (EU) Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has issued a positive opinion recommending approval of CAELYX(R) (pegylated liposomal doxorubicin hydrochloride) for the treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.
Teriparatide received a positive opinion last year from the European Committee for Proprietary Medicinal Products (CPMP) and could be the first bone formation agent to receive marketing authorisation in Europe.
ALZA Corporation (NYSE: AZA) announced today that the European Union's Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has recommended that CAELYX(R) (pegylated liposomal doxorubicin hydrochloride) be approved for the treatment of advanced ovarian cancer in women who have failed first line platinum-based therapy.
Nasdaq:ORPH), today announced that the European Committee for Proprietary Medicinal Products (CPMP) has recommended to the European Commission that Busulfex(R) (busulfan) Injection be approved for marketing in Europe as a conditioning treatment prior to haematopoietic progenitor stem cell or bone marrow transplantation in adult patients.
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