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• 30 Oct 2009 07:16

  30/10/09	CHMP revised EPARs on: MabtheraINN: rituximabRev. 21 ThelinINN: sitaxentan sodiumRev. 10 RevlimidINN: lenalidomideRev. 8	Human Medicines	EPARs
  30/10/09	Post-conference documents from the 'Fate of veterinary medicinal products in manure Focus Group Meeting' (23 June 2009)	Meetings & Events	Events
  30/10/09	Public summary of positive opinion for orphan designation of: - (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine dihydrochloride monohydrate (for the treatment of amyotrophic lateral sclerosis) - 5-(2,6-Difluoro-phenoxy)-3(R,S)-{2(S)-[2(S)-(3-methoxycarbonyl-2(S)-{3-methyl-2(S)-[(quinoline-2-carbonyl)-amino]-butyrylamino}-propionylamino)-3-methyl-butyrylamino]-propionylamino}-4-oxo-pentanoic acid methyl ester (for the treatment of neonatal brain injury) - adeno-associated viral vector serotype 5 containing the human ABCA4 gene (for the treatment of Stargardt’s disease) - allogeneic ex vivo expanded umbilical cord blood cells (for the treatment of acute lymphoblastic leukaemia) - allogeneic ex vivo expanded umbilical cord blood cells (for the treatment of acute myeloid leukaemia) - daunorubicin (liposomal) (for the treatment of acute myeloid leukaemia) - N-terminal hexaglutamine-tagged recombinant human N-acetylgalactosamine-6-sulfate sulfatase (for the treatment of mucopolysaccharidosis type IVA (Morquio A syndrome)) - palifosfamide (for the treatment of soft tissue sarcoma) - recombinant human proinsulin (for the treatment of retinitis pigmentosa)	Human Medicines	Orphan medicinal products - Summaries of opinion on orphan designation
  30/10/09	Public summary of negative opinion for orphan designation of: - 4-[[[4-(4-Chlorophenoxy)phenyl]sulfonyl]-methyl]tetrahydro- N-hydroxy-2H-pyran-4-carboxamide for the prevention of graft rejection after liver transplantation	Human Medicines	Orphan medicinal products - Summaries of opinion on orphan designation
  30/10/09	Press Release - AstraZeneca withdraws its marketing authorisation application for Zactima (vandetinib)	Human Medicines	Withdrawals of Application
  30/10/09	CHMP Blood Products Working Party (BPWP) work programme 2010	About us	CHMP working parties - BPWP
  29/10/09	Interim placement by an Interim Agency	Job opportunities
  29/10/09	Concept paper on the need for revision of the CHMP note for guidance on the clinical development of medicinal products in the treatment of asthma	Human Medicines	Scientific Guidelines - Clinical efficacy and safety
  29/10/09	Monthly report from the Pharmacovigilance Working Party (PhVWP) October 2009 meeting See also: Cumulative index of PhVWP monthly reports	Human Medicines	Pharmacovigilance guidelines and documents - Monthly reports
  29/10/09	EMEA post-authorisation procedural advice has been updated	Human Medicines	Application Procedures - Post-authorisation guidance

  30 October, 2009

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