Article 1 to 10 out of 43 concerning European Medicines Agency (EMEA)
Hybrigenics receives positive answers from EMEA(04 Feb 2010) EMEA gives official scientific advice on clinical Phase IIb efficacy study of inecalcitol in hormone-refractory prostate cancer Hybrigenics announced that it has received the official scientific advice from the European Medicines Agency (EMEA) on Hybrigenics' clinical development plan for inecalcitol in hormone-refractory prostate cancer patients.EMEA's recommendations back ...
NicOx submits naproxcinod MAA to the EMEA(23 Dec 2009) NicOx S.A. announced that a Marketing Authorization Application (MAA) for naproxcinod has been submitted to the European Medicines Agency (EMEA) through the centralized procedure, seeking approval for an indication for the relief of the signs and ...
Sanofi-aventis: Multaq(R) Approved in the European Union for Patients With Atrial Fibrillation(02 Dec 2009) First New Anti-Arrhythmic Drug to be Approved in the European Union in the Last 10 Years Sanofi-aventis announced that the European Commission has granted marketing authorization for Multaq(R) (dronedarone - 400mg Tablets) in all 27 European member states. This approval follows the European Commission positive opinion issued onSeptember ...
AMT Receives EMEA Orphan Drug Designation for Duchenne Muscular Dystrophy(15 Oct 2009) Amsterdam Molecular Therapeutics (AMT) announced that the European Medicines Agency has granted Orphan Drug Designation to AMT’s gene therapy product AMT-080 for the treatment of Duchenne muscular dystrophy.Orphan Drug Designation for Duchenne ...
Novartis A(H1N1) Pandemic Influenza vaccine Focetria receives positive opinion from CHMP(29 Sep 2009) Novartis announced that Focetria®, the Novartis Influenza A(H1N1) 2009 monovalent vaccine, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The positive opinion ...
UCB receives CHMP positive opinion on Keppra for infants and young children with partial-onset epilepsy(27 Jul 2009) European marketing approval recommended for Keppra (levetiracetam) as adjunctive treatment of partial-onset seizures in infants and young children aged one month to under four years UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending that the European Commission grant marketing authorisation for Keppra® as adjunctive ...
Sanofi-aventis welcomes the European Medicines Agency’s statement on Lantus safety(27 Jul 2009) Sanofi-aventis announced that following the review of the available evidence on Lantus® (insulin glargine [rDNA] injection), the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirmed the product’s safety and ...
Top