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28/02/2019 Overview of comments: Overview of comments received on 'Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry' (EMA/CHMP/SAWP/423488/2018)
28/02/2019 Scientific guideline: Qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry
28/02/2019 Veterinary pharmacovigilance inspections: Q&As
28/02/2019 News and press releases: First guidance on new rules for certain medical devices
28/02/2019 Adjustment for cross-over in estimating effects in oncology trials
28/02/2019 Regulatory and procedural guideline: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)
28/02/2019 Contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids
28/02/2019 Herbal - Call for data: Call for scientific data for use in HMPC assessment work on ‘Public statement on contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids (EMA/HMPC/328782/2016)’
28/02/2019 Use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs)
28/02/2019 Herbal - Call for data: Call for scientific data for use in HMPC assessment work on ‘Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) (EMA/HMPC/893108/2011)’
28/02/2019 Human medicines European public assessment report (EPAR): Zyprexa, olanzapine, Schizophrenia, Bipolar Disorder, 27/09/1996, 39, Authorised
27/02/2019 Human medicines European public assessment report (EPAR): Procoralan, ivabradine hydrochloride, Angina Pectoris, Heart Failure, 24/10/2005, 20, Authorised
27/02/2019 Human medicines European public assessment report (EPAR): Nucala, Mepolizumab, Asthma, 01/12/2015, Additional monitoring, 11, Authorised
27/02/2019 Other: Request form for eligibility for double daily allowance
27/02/2019 Template or form: Delegate financial identification form
27/02/2019 Human medicines European public assessment report (EPAR): Pioglitazone Accord, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 21/03/2012, Generic, 5, Authorised
27/02/2019 Human medicines European public assessment report (EPAR): Edurant, rilpivirine hydrochloride, HIV Infections, 28/11/2011, 15, Authorised
27/02/2019 Human medicines European public assessment report (EPAR): Zerbaxa, ceftolozane sulfate, tazobactam sodium, Bacterial Infections, 18/09/2015, Additional monitoring, 8, Authorised
27/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Domagrozumab, PM: decision on the application for modification of an agreed PIP, P/0327/2017
27/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): (S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) ( LIK066), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0183/2014
27/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H1N1Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H3N2Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B, PM: decision on the application for modification of an agreed PIP, P/208/2010
27/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Optaflu, Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145); A/Wisconsin/67/2005 (H3N2)-like strain (A/Wisconsin/67/2005, NYMC X161B); B/Malaysia/2506/2004-like strain (B/Malaysia/2506/2004), PM: decision on the application for modification of an agreed PIP, P/0210/2012
27/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0338/2014
27/02/2019 Medicines under additional monitoring: Annex X - List of domperidone-containing medicinal products in the European Union
27/02/2019 Medicines under additional monitoring: Annex X - List of domperidone-containing medicinal products in the European Union
27/02/2019 Human medicines European public assessment report (EPAR): Jardiance, empagliflozin, Diabetes Mellitus, Type 2, 22/05/2014, 16, Authorised
26/02/2019 News and press releases: Procedural update on submission of Type I variations to EMA in March, April and May 2019
26/02/2019 Agenda: Agenda - PDCO agenda of the 26 February - 1 March 2019 meeting
26/02/2019 Human medicines European public assessment report (EPAR): Blincyto, blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 23/11/2015, Orphan, Additional monitoring, 9, Authorised
26/02/2019 Human medicines European public assessment report (EPAR): Memantine Accord, memantine hydrochloride, Alzheimer Disease, 03/12/2013, Generic, 5, Authorised
26/02/2019 Human medicines European public assessment report (EPAR): Mircera, Methoxy polyethylene glycol-epoetin beta, Anemia, Kidney Failure, Chronic, 20/07/2007, 24, Authorised
26/02/2019 Human medicines European public assessment report (EPAR): PritorPlus, telmisartan, hydrochlorothiazide, Hypertension, 22/04/2002, 33, Authorised
26/02/2019 Report: Medicinal products for human use: monthly figures - January 2019
26/02/2019 Human medicines European public assessment report (EPAR): Triumeq, abacavir sulfate, dolutegravir sodium, lamivudine, HIV Infections, 31/08/2014, Patient safety, Additional monitoring, 12, Authorised
26/02/2019 Human medicines European public assessment report (EPAR): Macimorelin Aeterna Zentaris, macimorelin acetate, Diagnostic Techniques, Endocrine, 11/01/2019, Additional monitoring, Authorised
26/02/2019 Human medicines European public assessment report (EPAR): NovoRapid, insulin aspart, Diabetes Mellitus, 07/09/1999, 29, Authorised
26/02/2019 Human medicines European public assessment report (EPAR): Tresiba, insulin degludec, Diabetes Mellitus, 20/01/2013, 12, Authorised
26/02/2019 Human medicines European public assessment report (EPAR): Fiasp, insulin aspart, Diabetes Mellitus, 09/01/2017, Patient safety, Additional monitoring, 2, Authorised
25/02/2019 Human medicines European public assessment report (EPAR): Corlentor, ivabradine hydrochloride, Angina Pectoris, Heart Failure, 24/10/2005, 24, Authorised
25/02/2019 Agenda: Agenda - CHMP agenda of the 25-28 February 2019 meeting
25/02/2019 Orphan designation: Anetumab ravtansine for the: Treatment of ovarian cancer, 19/11/2018, Positive
25/02/2019 Human medicines European public assessment report (EPAR): Ivabradine Anpharm, ivabradine, Angina Pectoris, Heart Failure, 08/09/2015, 4, Authorised
25/02/2019 Orphan designation: Ile-Ser-Ile-Thr-Glu-Ile-Lys-Gly-Val-Ile-Val-His-Arg-Ile-Glu-Thr-Ile-Leu-Phe-Lys-Lys-Lys-Lys-Glu-Met-Pro-Ser-Glu-Glu-Gly-Tyr-Gln-Asp for the: Treatment of multiple system atrophy, 19/11/2018, Positive
25/02/2019 Human medicines European public assessment report (EPAR): Renvela, sevelamer carbonate, Hyperphosphatemia, Renal Dialysis, 09/06/2009, 18, Authorised
25/02/2019 Orphan designation: H-Arg-Pro-Lys-Pro-Gln-Gln-Phe-2Thi-Gly-Leu-Met(O2)-NH2-DOTA-213-bismuth for the: Treatment of glioma, 19/11/2018, Positive
25/02/2019 Orphan designation: Etamsylate for the: Treatment of hereditary haemorrhagic telangiectasia, 19/11/2018, Positive
25/02/2019 Orphan designation: Ex vivo fused normal allogeneic human myoblast with another normal allogeneic human myoblast for the: Treatment of Duchenne muscular dystrophy, 19/11/2018, Positive
25/02/2019 Orphan designation: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor for the: Treatment of Duchenne muscular dystrophy, 19/11/2019, Positive
25/02/2019 Orphan designation: Anti-GD2 monoclonal antibody 3F8 humanised for the: Treatment of neuroblastoma, 19/11/2018, Positive
25/02/2019 Orphan designation: Lisocabtagene maraleucel for the: Treatment of primary mediastinal large-B-cell lymphoma, 19/11/2018, Positive
25/02/2019 Orphan designation: Allogeneic faecal microbiota, pooled for the: Treatment of graft-versus-host-disease, 19/11/2018, Positive
25/02/2019 Template for information exchange for the preparation of the assessment report supporting the establishment of European Union monographs and European Union list entries
25/02/2019 Non-clinical documentation in applications for marketing authorisation / registration of well-established and traditional herbal medicinal products
25/02/2019 Template or form: Exclusion criteria declaration form
25/02/2019 Report: Hearing with the Association of the European Self-Medication Industry during the September 2018 Working Party on Community Monographs and Community List meeting
22/02/2019 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 February 2019
22/02/2019 Maximum Residue Limits - Summary of opinion: Ciclesonide - Summary opinion of the CVMP on the establishment of maximum residue limits
22/02/2019 Summary of opinion: HorStem, equine umbilical cord mesenchymal stem cells, 21/02/2019, Positive
22/02/2019 Regulatory and procedural guideline: Checking process of mock-ups and specimens of outer / immediate labelling and package leaflets of human medicinal products in the centralised procedure
22/02/2019 Template or form: Joint audit programme for EEA GMP inspectorates: Follow-up on CAPA implementation
22/02/2019 Joint Audit Programme
22/02/2019 Orphan designation: Smilagenin for the: Treatment of amyotrophic lateral sclerosis, 27/09/2011, Positive
22/02/2019 Orphan designation: Adult human bone-marrow-derived, ex-vivo-expanded, pooled allogeneic mesenchymal stromal cells for the: Treatment of thromboangiitis obliterans (Buerger's disease), 21/05/2015, Positive
22/02/2019 Orphan designation: Choline tetrathiomolybdate for the: Treatment of Wilson's disease, 24/01/2013, Positive
22/02/2019 Orphan designation: Triheptanoin for the: Treatment of mitochondrial trifunctional protein deficiency, 28/07/2015, Positive
22/02/2019 ICH M9 on biopharmaceutics classification system based biowaivers
22/02/2019 Orphan designation: Larotrectinib for the: Treatment of papillary thyroid cancer, 19/11/2018, Positive
22/02/2019 Orphan designation: Triheptanoin for the: Treatment of long-chain 3-hydroxyacyl-coA dehydrogenase deficiency, 28/07/2015, Positive
22/02/2019 Orphan designation: Triheptanoin for the: Treatment of very long-chain acyl-CoA dehydrogenase deficiency, 19/06/2015, Positive
22/02/2019 Orphan designation: Pegylated recombinant human hyaluronidase PH20(pegvorhyaluronidase alfa) for the: Treatment of pancreatic cancer, 16/12/2014, Positive
22/02/2019 Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor for the: Treatment of follicular lymphoma, 25/05/2018, Positive
22/02/2019 Orphan designation: Modified recombinant human C-type natriuretic peptide (Vosoritide) for the: Treatment of achondroplasia, 24/01/2013, Positive
22/02/2019 Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor for the: Treatment of diffuse large B-cell lymphoma, 17/07/2017, Positive
22/02/2019 Minutes: Minutes of the 102nd meeting of the Management Board
21/02/2019 Scientific guideline: Draft guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials
21/02/2019 Orphan designation: Ciprofloxacin (inhalation use) for the: Treatment of cystic fibrosis, 03/08/2007, Withdrawn
21/02/2019 Orphan designation: Chimeric monoclonal antibody against GD2 (dinutuximab) for the: Treatment of neuroblastoma, 21/06/2011, Withdrawn
21/02/2019 Orphan designation: Celecoxib for the: Treatment of familial adenomatous polyposis (FAP), 21/11/2001, Withdrawn
21/02/2019 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: January 2019
21/02/2019 Orphan designation: Rilonacept for the: Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn
21/02/2019 Orphan designation: 2-Allyl-1-[6-(1-hydroxy-1-methylethyl)pyridin-2-yl]-6-{[4-(4-methylpiperazin-1-yl)phenyl]amino}-1,2-dihydro-3H-pyrazolo[3,4-d]pyrimidin-3-one for the: Treatment of ovarian cancer, 26/04/2012, Withdrawn
21/02/2019 Orphan designation: Amphotericin B (for inhalation use) for the: Prevention of pulmonary fungal infection in patients deemed at risk, 28/08/2006, Withdrawn
21/02/2019 Orphan designation: Halofuginone hydrobromide for the: Treatment of Duchenne muscular dystrophy, 26/04/2012, Withdrawn
21/02/2019 Human medicines European public assessment report (EPAR): Torisel, Temsirolimus, Carcinoma, Renal Cell, Lymphoma, Mantle-Cell, 19/11/2007, Orphan, 29, Authorised
21/02/2019 Orphan designation: riociguat for the: Treatment of systemic sclerosis, 29/07/2014, Withdrawn
21/02/2019 Orphan designation: Recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains (somavaratan) for the: Treatment of growth-hormone deficiency, 05/08/2013, Withdrawn
21/02/2019 Orphan designation: Adeno-associated viral vector containing DNA encoding an RNAi targeting rhodopsin, adeno-associated viral vector containing a rhodopsin gene for the: Treatment of rhodopsin-linked retinitis pigmentosa, 17/12/2010, Withdrawn
21/02/2019 Orphan designation: Becatecarin for the: Treatment of cancers of the biliary tree, 25/07/2006, Withdrawn
21/02/2019 Orphan designation: N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4 methylpiperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide (entrectinib) for the: Treatment of neuroblastoma, 11/11/2015, Withdrawn
21/02/2019 Orphan designation: Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes for the: Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at..., 09/08/2012, Withdrawn
21/02/2019 Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt for the: Treatment of mantle-cell lymphoma, 01/10/2010, Withdrawn
21/02/2019 Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt for the: Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn
21/02/2019 Minutes: Minutes of the CHMP meeting 10-13 December 2018
21/02/2019 Orphan designation: Tideglusib for the: Treatment of fragile X syndrome, 19/03/2015, Withdrawn
21/02/2019 Orphan designation: Iodine (131I) chlorotoxin for the: Treatment of glioma, 22/10/2007, Withdrawn
21/02/2019 Orphan designation: Isofagomine tartrate for the: Treatment of Gaucher disease, 23/10/2007, Withdrawn
21/02/2019 Orphan designation: Obinutuzumab for the: Treatment of diffuse large B-cell lymphoma, 22/08/2014, Withdrawn
21/02/2019 News and press releases: EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database
21/02/2019 Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers , European Medicines Agency, London, UK, from 26/10/2018 to 26/10/2018
21/02/2019 Periodic safety update single assessment: Misoprostol (gastrointestinal indication): List of nationally authorised medicinal products - PSUSA/00010291/201806
21/02/2019 Human medicines European public assessment report (EPAR): Firazyr, icatibant, Angioedemas, Hereditary, 11/07/2008, Orphan, 16, Authorised
21/02/2019 Human medicines European public assessment report (EPAR): Aldurazyme, laronidase, Mucopolysaccharidosis I, 09/06/2003, Orphan, 18, Authorised
21/02/2019 Eligible healthcare professionals' organisations
21/02/2019 Human medicines European public assessment report (EPAR): Ritemvia, rituximab, Lymphoma, Non-Hodgkin, Microscopic Polyangiitis, Wegener Granulomatosis, 13/07/2017, Additional monitoring, Biosimilar, 6, Authorised
20/02/2019 Periodic safety update single assessment: Solifenacin / tamsulosin: List of nationally authorised medicinal products - PSUSA/00010285/201807
20/02/2019 Periodic safety update single assessment: Calcitonin salmon, synthetic analogue of eel calcitonin: List of nationally authorised medicinal products - PSUSA/00000494/201806
20/02/2019 Periodic safety update single assessment: Fosinopril, fosinopril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00010463/201807
20/02/2019 Periodic safety update single assessment: Dexchlorpheniramine: List of nationally authorised medicinal products - PSUSA/00000989/201806
20/02/2019 Periodic safety update single assessment: Nimesulide (systemic formulations): List of nationally authorised medicinal products - PSUSA/00009236/201806
20/02/2019 Periodic safety update single assessment: Pipobroman: List of nationally authorised medicinal products - PSUSA/00002427/201806
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Prevymis, Letermovir, PM: decision on the application for modification of an agreed PIP, P/0385/2018
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate), PM: decision on the application for modification of an agreed PIP, P/0357/2018
20/02/2019 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 14-17 January 2019 PRAC meeting
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): tezepelumab, PM: decision on the application for modification of an agreed PIP, P/0316/2014
20/02/2019 Periodic safety update single assessment: Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201806
20/02/2019 Veterinary medicines European public assessment report (EPAR): Palladia, toceranib, 23/09/2009, 8, Authorised
20/02/2019 Periodic safety update single assessment: Levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack): List of nationally authorised medicinal products - PSUSA/00010442/201807
20/02/2019 Periodic safety update single assessment: Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/2018
20/02/2019 Periodic safety update single assessment: Nilutamide: List of nationally authorised medicinal products - PSUSA/00002163/201807
20/02/2019 Periodic safety update single assessment: Cefepime: List of nationally authorised medicinal products - PSUSA/00000593/201806
20/02/2019 Periodic safety update single assessment: Tiagabine: List of nationally authorised medicinal products - PSUSA/00002942/201806
20/02/2019 Periodic safety update single assessment: Phenylpropanolamine: List of nationally authorised medicinal products - PSUSA/00010483/201806
20/02/2019 Periodic safety update single assessment: Pitavastatin: List of nationally authorised medicinal products - PSUSA/00010502/201807
20/02/2019 Periodic safety update single assessment: Rizatriptan: List of nationally authorised medicinal products - PSUSA/00002655/201806
20/02/2019 Periodic safety update single assessment: Urapidil: List of nationally authorised medicinal products - PSUSA/00003078/201807
20/02/2019 Human medicines European public assessment report (EPAR): Fuzeon, enfuvirtide, HIV Infections, 27/05/2003, 20, Authorised
20/02/2019 Orphan designation: Histamine dihydrochloride for the: Treatment of acute myeloid leukaemia, 11/04/2005, Expired
20/02/2019 Orphan designation: miglustat for the: Treatment of Niemann-Pick disease, type C, 16/02/2006, Expired
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Taltz, ixekizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0352/2018
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Kevzara, sarilumab, W: decision granting a waiver in all age groups for all conditions/indications, P/0356/2018
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Cholera vaccine, live attenuated, oral (strain CVD 103-HgR), PM: decision on the application for modification of an agreed PIP, P/0381/2018
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Orkambi, Lumacaftor,ivacaftor, PM: decision on the application for modification of an agreed PIP, P/0407/2018
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), PM: decision on the application for modification of an agreed PIP, P/0367/2018
20/02/2019 Orphan designation: azacitidine for the: Treatment of myelodysplastic syndromes, 06/02/2002, Expired
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): bupivacaine, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0402/2018
20/02/2019 Human medicines European public assessment report (EPAR): Ozempic, semaglutide, Diabetes Mellitus, 08/02/2018, Additional monitoring, 2, Authorised
20/02/2019 Orphan designation: azacitidine for the: Treatment of acute myeloid leukaemia, 29/11/2007, Expired
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Forxiga, dapagliflozin, W: decision granting a waiver in all age groups for all conditions/indications, P/0373/2018
20/02/2019 Orphan designation: Rufinamide for the: Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired
20/02/2019 Orphan designation: Recombinant megakaryopoiesis-stimulating protein for the: Treatment of idiopathic thrombocytopenic purpura, 27/05/2005, Expired
20/02/2019 Other: Questions and answers on impact of European Union-United States mutual recognition agreement on marketing authorisation applications and relevant variations
20/02/2019 Human medicines European public assessment report (EPAR): Natpar, parathyroid hormone, Hypoparathyroidism, 24/04/2017, Orphan, Additional monitoring, Conditional approval, 5, Authorised
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): lasmiditan, PM: decision on the application for modification of an agreed PIP, P/0358/2018
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Xalkori, crizotinib, W: decision granting a waiver in all age groups for all conditions/indications, P/0361/2018
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Upadacitinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0394/2018
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Brincidofovir, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0348/2018
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Brincidofovir, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0349/2018
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc], PM: decision on the application for modification of an agreed PIP, P/0387/2018
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, PM: decision on the application for modification of an agreed PIP, P/0400/2018
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0354/2018
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Risdiplam (RO7034067), PM: decision on the application for modification of an agreed PIP, P/0360/2018
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Complex of povidone and iodine,dexamethasone (SHP640), PM: decision on the application for modification of an agreed PIP, P/0369/2018
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): (RS)-Bacoflen,Naltrexone HCl,D-Sorbitol (PXT3003), PM: decision on the application for modification of an agreed PIP, P/0363/2018
20/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Liposomal combination of cytarabine and daunorubicin, PM: decision on the application for modification of an agreed PIP, P/0388/2018
20/02/2019 Human medicines European public assessment report (EPAR): Eperzan, Albiglutide, Diabetes Mellitus, Type 2, 20/03/2014, 8, Withdrawn
20/02/2019 Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand for the: The treatment of pancreatic cancer, 19/11/2018, Positive
19/02/2019 Orphan designation: Larotrectinib for the: Treatment of glioma, 19/11/2018, Positive
19/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): filgotinib, PM: decision on the application for modification of an agreed PIP, P/0371/2018
19/02/2019 Orphan designation: fidanacogene elaparvovec for the: Treatment of haemophilia B, 19/11/2018, Positive
19/02/2019 Periodic safety update single assessment: Aciclovir: List of nationally authorised medicinal products - PSUSA/00000048/201806
19/02/2019 Orphan designation: apraglutide for the: Treatment of short bowel syndrome, 19/11/2018, Positive
19/02/2019 Orphan designation: 4-[[(1S,4S)-5-[[4-[4-(oxazol-2-yl)phenoxy]phenyl]methyl]-2,5-diazabicyclo[2.2.1]hept-2-yl]methyl]benzoic acid for the: Treatment of cystic fibrosis, 19/11/2014, Positive
19/02/2019 Orphan designation: human apotransferrin for the: Treatment of beta-thalassaemia intermedia and major, 19/11/2018, Positive
19/02/2019 Human medicines European public assessment report (EPAR): Combivir, lamivudine, zidovudine, HIV Infections, 18/03/1998, 29, Authorised
19/02/2019 Human medicines European public assessment report (EPAR): Thymanax, Agomelatine, Depressive Disorder, Major, 19/02/2009, 18/11/2006, 19, Authorised
19/02/2019 Orphan designation: cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate for the: Treatment of cystic fibrosis, 19/11/2018, Positive
19/02/2019 Human medicines European public assessment report (EPAR): Darzalex, Daratumumab, Multiple Myeloma, 28/04/2017, Orphan, Additional monitoring, 8, Authorised
19/02/2019 Human medicines European public assessment report (EPAR): Matever, levetiracetam, Epilepsy, 03/10/2011, Generic, 18, Authorised
19/02/2019 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka, emtricitabine, tenofovir disoproxil succinate, HIV Infections, 09/12/2016, Generic, 4, Authorised
19/02/2019 Human medicines European public assessment report (EPAR): Vaxelis, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3, hepatitis B surface antigen produced in yeast cells, poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein., Meningitis, Haemophilus, Poliomyelitis, Tetanus, Diphtheria, Whooping Cough, Hepatitis B, 15/02/2016, Additional monitoring, 6, Authorised
19/02/2019 Orphan designation: propagermanium for the: Treatment of focal segmental glomerulosclerosis, 19/11/2018, Positive
19/02/2019 Periodic safety update single assessment: Oxycodone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002254/201804
19/02/2019 Periodic safety update single assessment: Oxycodone: List of nationally authorised medicinal products - PSUSA/00002254/201804
19/02/2019 Orphan designation: 3-(3-(3,5-Dimethyl-1H-pyrazol-4-yl)propoxy)-4-fluorobenzoic acid for the: Treatment of ATTR amyloidosis, 19/11/2018, Positive
19/02/2019 Human medicines European public assessment report (EPAR): Inlyta, axitinib, Carcinoma, Renal Cell, 03/09/2012, 9, Authorised
19/02/2019 Orphan designation: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride for the: Treatment of Kabuki syndrome, 19/11/2018, Positive
19/02/2019 Orphan designation: Rucaparib for the: Treatment of ovarian cancer, 10/10/2012, Withdrawn
19/02/2019 Human medicines European public assessment report (EPAR): Kovaltry, octocog alfa, Hemophilia A, 18/02/2016, Additional monitoring, 6, Authorised
19/02/2019 Human medicines European public assessment report (EPAR): Circadin, melatonin, Sleep Initiation and Maintenance Disorders, 29/06/2007, 29, Authorised
19/02/2019 Orphan designation: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2 for the: Treatment of glioma, 23/08/2017, Positive
19/02/2019 Veterinary medicines European public assessment report (EPAR): Emdocam, meloxicam, 18/08/2011, Generic, 6, Authorised
19/02/2019 Human medicines European public assessment report (EPAR): Cubicin, daptomycin, Gram-Positive Bacterial Infections, Bacteremia, Soft Tissue Infections, Endocarditis, Bacterial, 19/01/2006, 31, Authorised
19/02/2019 Human medicines European public assessment report (EPAR): Thyrogen, thyrotropin alfa, Thyroid Neoplasms, 09/03/2000, 23, Authorised
19/02/2019 EPAR - All authorised presentations: Dengvaxia : EPAR - All authorised presentations
19/02/2019 Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Venous Thromboembolism, 15/09/2016, Additional monitoring, Biosimilar, 10, Authorised
19/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro, Ixazomib, PM: decision on the application for modification of an agreed PIP, P/0376/2018
19/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Lenvima, Lenvatinib, PM: decision on the application for modification of an agreed PIP, P/0389/2018
19/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride,ketorolac trometamol (OMS302), W: decision granting a waiver in all age groups for all conditions/indications, P/0362/2018
19/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Tolvaptan, PM: decision on the application for modification of an agreed PIP, P/0378/2018
19/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): 4-((2R,3S,4R,5S)-3-(3-Chloro-2-fluorophenyl)-4-(4-chloro-2-fluorophenyl)-4-cyano-5-neopentylpyrrolidine-2-carboxamido)-3-methoxybenzoic acid (RO5503781), PM: decision on the application for modification of an agreed PIP, P/0366/2018
19/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,Potassium hydrogen carbonate, PM: decision on the application for modification of an agreed PIP, P/0355/2018
19/02/2019 EPAR - Assessment report - Variation: Gilenya-H-C-2202-X-0044-G : EPAR - Assessment Report - Variation
18/02/2019 Periodic safety update single assessment: Nortriptyline: List of nationally authorised medicinal products - PSUSA/00002192/201803
18/02/2019 Periodic safety update single assessment: Pelargonium sidoides dc and/or pelargonium reniforme curt. / radix: List of nationally authorised medicinal products - PSUSA/00002329/201806
18/02/2019 Periodic safety update single assessment: Pholcodine / biclotymol / chlorphenamine maleate : List of nationally authorised medicinal products - PSUSA/00010437201804
18/02/2019 Periodic safety update single assessment: Nortriptyline: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementatio - PSUSA/00002192/201803
18/02/2019 Minutes: Minutes of the COMP meeting 6-8 November 2018
18/02/2019 Agenda: Agenda - COMP agenda of the 19-21 February 2019 meeting
18/02/2019 Human medicines European public assessment report (EPAR): Rituzena (previously Tuxella), rituximab, Lymphoma, Non-Hodgkin, Microscopic Polyangiitis, Leukemia, Lymphocytic, Chronic, B-Cell, Wegener Granulomatosis, 13/07/2017, Additional monitoring, Biosimilar, 7, Authorised
18/02/2019 Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva, emtricitabine, tenofovir disoproxil phosphate, HIV Infections, 09/11/2016, Generic, 2, Authorised
18/02/2019 Human medicines European public assessment report (EPAR): Alunbrig, brigatinib, Carcinoma, Non-Small-Cell Lung, 22/11/2018, Additional monitoring, 1, Authorised
18/02/2019 Human medicines European public assessment report (EPAR): Elocta, efmoroctocog alfa, Hemophilia A, 18/11/2015, Additional monitoring, 7, Authorised
18/02/2019 Veterinary medicines European public assessment report (EPAR): Vectra Felis, pyriproxyfen, dinotefuran, 06/06/2014, 2, Authorised
18/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Cimzia, Certolizumab pegol, W: decision granting a waiver in all age groups for all conditions/indications, P/0397/2018
18/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Holoclar, Ex-vivo expanded human autologous epithelium containing stem cells, PM: decision on the application for modification of an agreed PIP, P/0370/2018
18/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Taltz, ixekizumab, PM: decision on the application for modification of an agreed PIP, P/0351/2018
18/02/2019 Human medicines European public assessment report (EPAR): SomaKit TOC, edotreotide, Neuroendocrine Tumors, Radionuclide Imaging, 08/12/2016, Orphan, Additional monitoring, 3, Authorised
18/02/2019 Human medicines European public assessment report (EPAR): Lysodren, Mitotane, Adrenal Cortex Neoplasms, 28/04/2004, Orphan, 13, Authorised
18/02/2019 Human medicines European public assessment report (EPAR): Ketoconazole HRA, Ketoconazole, Cushing Syndrome, 18/11/2014, Orphan, Additional monitoring, 8, Authorised
18/02/2019 Minutes: Minutes - PDCO minutes of the 16-19 October 2018 meeting
18/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Sirturo, Bedaquiline (fumarate), PM: decision on the application for modification of an agreed PIP, P/0403/2018
18/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab, PM: decision on the application for modification of an agreed PIP, P/0364/2018
18/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Lyxumia, lixisenatide, PM: decision on the application for modification of an agreed PIP, P/0380/2018
18/02/2019 Industry stakeholder meeting on Brexit and operation of the centralised procedure for human and veterinary medicine products , European Medicines Agency, London, UK, from 28/01/2019 to 28/01/2019
18/02/2019 Human medicines European public assessment report (EPAR): ellaOne, ulipristal, Contraception, Postcoital, 15/05/2009, 19, Authorised
18/02/2019 Veterinary medicines European public assessment report (EPAR): Oxyglobin, haemoglobin glutamer-200 (bovine), 29/11/1999, 15, Authorised
18/02/2019 EPAR - Procedural steps taken and scientific information after authorisation: SomaKit TOC : EPAR - Procedural steps taken and scientific information after authorisation
15/02/2019 Leaflet: Orientation guide for delegates - Spark building
15/02/2019 Referral: Diotop capsules , diclofenac/omeprazole , Article 29(4) referrals, European Commission final decision, 15/11/2018, 31/01/2019, 15/02/2019
15/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Otezla, apremilast, PM: decision on the application for modification of an agreed PIP, P/0398/2018
15/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco, ivacaftor, PM: decision on the application for modification of an agreed PIP, P/0353/2018
15/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera), Ceftobiprole medocaril (sodium), PM: decision on the application for modification of an agreed PIP, P/0406/2018
15/02/2019 News and press releases: Suspension of fenspiride medicines due to potential risk of heart rhythm problems
15/02/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019
15/02/2019 Other: HMA/EMA Joint Task Force on big data – Survey for national competent authorities
15/02/2019 Other: HMA/EMA Joint Task Force on big data – Survey for pharmaceutical industry
15/02/2019 Other: HMA/EMA Joint Task Force on big data – Surveys results
15/02/2019 News and press releases: Role of big data for evaluation and supervision of medicines in the EU
15/02/2019 Minutes: HMA/EMA Joint Task Force on big data – Summary report
15/02/2019 Big data
15/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Pradaxa, Dabigatran etexilate mesilate, PM: decision on the application for modification of an agreed PIP, P/0399/2018
15/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), PM: decision on the application for modification of an agreed PIP, P/0401/2018
15/02/2019 Herbal medicinal product: Taraxaci radix cum herba, Taraxaci radix cum herba, F: Assessment finalised
15/02/2019 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Taraxacum officinale Weber ex Wigg., radix cum herba
15/02/2019 Herbal medicinal product: Taraxaci folium, Taraxaci folium, F: Assessment finalised
15/02/2019 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Taraxacum officinale Weber ex Wigg., folium
15/02/2019 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Rosmarinus officinalis L., aetheroleum
15/02/2019 Herbal medicinal product: Rosmarini folium, Rosmarini folium, F: Assessment finalised
15/02/2019 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Rosmarinus officinalis L., folium
15/02/2019 Herbal medicinal product: Orthosiphonis folium, Orthosiphonis folium, F: Assessment finalised
15/02/2019 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Orthosiphon stamineus Benth., folium
15/02/2019 Herbal medicinal product: Juniperi pseudo-fructus, Juniperi pseudo-fructus, F: Assessment finalised
15/02/2019 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Juniperus communis L., pseudo-fructus
15/02/2019 Herbal medicinal product: Juniperi aetheroleum, Juniperi aetheroleum, F: Assessment finalised
15/02/2019 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Juniperus communis L., aetheroleum
15/02/2019 Herbal medicinal product: Arctii radix, Arctii radix, F: Assessment finalised
15/02/2019 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Arctium lappa L., radix
15/02/2019 Herbal medicinal product: Frangulae cortex, Frangulae cortex, F: Assessment finalised
14/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Cialis, tadalafil, PM: decision on the application for modification of an agreed PIP, P/0395/2018
14/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Lixiana, Edoxaban (tosylate), PM: decision on the application for modification of an agreed PIP, P/0368/2018