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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 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 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): 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): Macimorelin Aeterna Zentaris, macimorelin acetate, Diagnostic Techniques, Endocrine, 11/01/2019, Additional monitoring, Authorised
26/02/2019 Human medicines European public assessment report (EPAR): Tresiba, insulin degludec, Diabetes Mellitus, 20/01/2013, 12, 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 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 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, 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, 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): Aldurazyme, laronidase, Mucopolysaccharidosis I, 09/06/2003, Orphan, 18, 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's 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 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): (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 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): Matever, levetiracetam, Epilepsy, 03/10/2011, Generic, 18, 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 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 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 EPAR - All authorised presentations: Dengvaxia : EPAR - All authorised presentations
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): Alunbrig, brigatinib, Carcinoma, Non-Small-Cell Lung, 22/11/2018, Additional monitoring, 1, 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 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 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 Big data
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 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
14/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx, Secukinumab, PM: decision on the application for modification of an agreed PIP, P/0372/2018
14/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Votrient, pazopanib, PM: decision on the application for modification of an agreed PIP, P/0405/2018
14/02/2019 Leaflet: Infographic on Article 58 procedure
14/02/2019 Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Osteoporosis, 07/01/2019, Refused
14/02/2019 Herbal medicinal product: Silybi mariani fructus, Silybi mariani fructus, F: Assessment finalised
14/02/2019 Herbal medicinal product: Curcumae longae rhizoma, Curcumae longae rhizoma, F: Assessment finalised
14/02/2019 Other: Decision on rules relating to Articles 11, 11a and 13 of the Staff Regulations concerning the handling of declared interests of staff members of the European Medicines Agency and candidates before recruitment
14/02/2019 Committee meeting report: COMP meeting report on the review of applications for orphan designation: December 2018
14/02/2019 Referral: Diclofenac Sodium Spray Gel 4% , diclofenac sodium , Article 29(4) referrals, European Commission final decision, 15/11/2018, 18/01/2019, 14/02/2019
14/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Evinacumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0404/2018
14/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): SER-109 (Eubacterial Spores, Purified Suspension, Encapsulated), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0390/2018
14/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Cenicriviroc, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0392/2018
14/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Calcifediol, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0339/2018
14/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Evobrutinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0393/2018
14/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): brigatinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0350/2018
14/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Janus Kinase-1 inhibitor (PF-04965842), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0391/2018
14/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): pemigatinib, W: decision granting a waiver in all age groups for all conditions/indications, P/0386/2018
13/02/2019 Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase for the: Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive
13/02/2019 Orphan designation: Imlifidase for the: Treatment of anti-glomerular basement membrane disease, 19/11/2018, Positive
13/02/2019 Orphan designation: Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase) for the: Prevention of graft rejection following solid organ transplantation, 12/01/2017, Positive
13/02/2019 Orphan designation: Agammaglobulinaemia tyrosine kinase for the: Treatment of pemphigus, 12/12/2017, Positive
13/02/2019 Orphan designation: 2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl) acetamide for the: Treatment of cystic fibrosis, 21/05/2015, Positive
13/02/2019 Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide for the: Treatment of acute myeloid leukaemia, 14/10/2016, Positive
13/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Alecensa, Alectinib, W: decision granting a waiver in all age groups for all conditions/indications, P/0359/2018
13/02/2019 Orphan designation: Humanised single-chain monoclonal antibody against CD37 (otlertuzumab) for the: Treatment chronic lymphocytic leukaemia, 06/12/2012, Positive
13/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Flurpiridaz F18, W: decision granting a waiver in all age groups for all conditions/indications, P/0396/2018
13/02/2019 Orphan designation: Seladelpar for the: Treatment of primary biliary cholangitis, 16/10/2017, Positive
13/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin,Ezetimibe, W: decision granting a waiver in all age groups for all conditions/indications, P/0374/2018
13/02/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ipatasertib, W: decision granting a waiver in all age groups for all conditions/indications, P/0383/2018