Article 1 to 10 out of 27 concerning European Medicines Agency (EMEA)
Merck Serono's Kuvan Recommended for European Approval(30 Sep 2008) CHMP Issued Positive Opinion Recommending Marketing Authorization of Kuvan(R) for the Treatment of hyperphenylalaninemia in Patients With phenylketonuria or BH4 Deficiency Merck Serono, a division of Merck KGaA announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), issued a positive opinion for Kuvan(R) (sapropterin dihydrochloride) ...
EMEA grants Kiadis Pharma lead product ATIR orphan drug designation(24 Sep 2008) Kiadis Pharma announced that its lead product ATIR™ has been granted orphan drug designation (ODD) by the European Medicines Agency (EMEA) for the prevention of acute Graft versus Host Disease (GvHD) following an allogeneic bone marrow ...
EMEA recommends Orphan Drug Designation for AX200 in the treatment of Spinal Cord Injury(22 Sep 2008) SYGNIS Pharma AG announced that it has received a positive recommendation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) for AX200 in the treatment of spinal cord injury.A spinal cord injury (SCI) is ...
UCB's Cimzia® filed with EMEA for treatment of rheumatoid arthritis(03 Jul 2008) The European marketing authorisation application for Cimzia® has been filed. Subject to approval, Cimzia® will be the first and only PEGylated, Fc-Free anti-TNF (Tumour Necrosis Factor alpha) biologic therapy. UCB announced that a Marketing Authorisation Application (MAA) has been submitted to the European Medicines Agency (EMEA) requesting the approval of Cimzia® (certolizumab pegol) as a subcutaneous treatment for adults with moderate to severe active ...
ATIR classified as "cell based" medicinal product by the EMEA(18 Dec 2007) Kiadis Pharma announced that its lead product ATIR has received approval for regulatory classification as a "cell based" medicinal product by the Innovation Task Force (ITF), a division of the European Medicines Agency (EMEA). Based upon this ...
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