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17/06/2019 Periodic safety update single assessment: Everolimus (indicated for rejection of transplanted organs) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010269/201807 (updated)
17/06/2019 Human medicines European public assessment report (EPAR): Voncento, Human coagulation factor VIII, human von willebrand factor, Hemophilia A, von Willebrand Diseases, 12/08/2013, 12, Authorised (updated)
17/06/2019 Human medicines European public assessment report (EPAR): Intrarosa, Prasterone, Menopause, 08/01/2018, Additional monitoring, 3, Authorised (updated)
17/06/2019 Human medicines European public assessment report (EPAR): Afstyla, lonoctocog alfa, Hemophilia A, 04/01/2017, Additional monitoring, 4, Authorised (updated)
14/06/2019 Human medicines European public assessment report (EPAR): Wilzin, zinc, Hepatolenticular Degeneration, 12/10/2004, Orphan, 11, Authorised (updated)
14/06/2019 Orphan designation: Diacerein for the: Treatment of epidermolysis bullosa, 08/11/2018, Negative
14/06/2019 Orphan designation: Eculizumab for the: Treatment of neuromyelitis optica spectrum disorders, 05/08/2013, Positive (updated)
14/06/2019 Orphan designation: Sodium benzoate, Sodium phenylacetate for the: Treatment of ornithine transcarbamylase deficiency, 24/04/2019, Positive
14/06/2019 Orphan designation: Human culture expanded autologous mesenchymal stromal cells for the: Treatment of amyotrophic lateral sclerosis, 24/04/2019, Positive
14/06/2019 Report: Final programming document 2019-2021
14/06/2019 Referral: Leuprorelin-containing depot medicinal products , leuprorelin , See "List of the medicines affected by the referral (Annex I)", Article 31 referrals, Procedure started
14/06/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2019
14/06/2019 Orphan designation: Balipodect for the: Treatment of fragile X syndrome, 14/04/2019, Positive
14/06/2019 Orphan designation: Autologous human bone marrow-derived haematopoietic and mesenchymal stem cells depleted of erythrocytes, monocytes and lymphocytes for the: Treatment of spinal cord injury, 24/04/2019, Positive
14/06/2019 Orphan designation: 3-(3-(3,5-bis(trifluoromethyl)phenyl)-1h-pyrazol-1-yl)propanoic acid for the: Treatment of Stargardt's disease, 24/04/2019, Positive
14/06/2019 Report: Applications for new human medicines under evaluation by the CHMP: June 2019
14/06/2019 Procurement (updated)
14/06/2019 Human medicines European public assessment report (EPAR): Grepid, clopidogrel besilate, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 27/07/2009, Generic, 18, Authorised (updated)
14/06/2019 Agenda: Agenda for the 104th meeting of the Management Board (updated)
14/06/2019 Human medicines European public assessment report (EPAR): Docetaxel Kabi, docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms, 22/05/2012, Generic, 12, Authorised (updated)
14/06/2019 Human medicines European public assessment report (EPAR): Olanzapine Teva, olanzapine, Schizophrenia, Bipolar Disorder, 12/12/2007, Generic, 24, Authorised (updated)
14/06/2019 Human medicines European public assessment report (EPAR): Cystadrops, mercaptamine hydrochloride, Cystinosis, 18/01/2017, Orphan, 5, Authorised (updated)
14/06/2019 Human medicines European public assessment report (EPAR): Velmetia, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 16/07/2008, 26, Authorised (updated)
14/06/2019 Mosquirix H-W-2300 (updated)
14/06/2019 Minutes: Minutes of the 103rd meeting of the Management Board: 21 March 2019
14/06/2019 Management Board meeting: 21 March 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 21/03/2019 to 21/03/2019 (updated)
14/06/2019 Orphan designation: Modified messenger ribonucleic acid encoding human propionyl-coenzyme A carboxylase alpha and beta subunits encapsulated into lipid nanoparticle for the: Treatment of propionic acidaemia, 24/04/2019, Positive
13/06/2019 Referral: Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction , Omega-3 fatty acid ethyl esters , Article 31 referrals, European Commission final decision, 13/12/2018, 06/06/2019, 13/06/2019 (updated)
13/06/2019 Human medicines European public assessment report (EPAR): Sancuso, granisetron, Vomiting, Cancer, 20/04/2012, 12, Authorised (updated)
13/06/2019 Human medicines European public assessment report (EPAR): Clopidogrel Mylan, clopidogrel hydrochloride, Peripheral Vascular Diseases, Stroke, Myocardial Infarction, 21/09/2009, Generic, 13, Authorised (updated)
13/06/2019 Veterinary medicines European public assessment report (EPAR): Bravecto, fluralaner, 11/02/2014, 8, Authorised (updated)
13/06/2019 Human medicines European public assessment report (EPAR): Latuda, lurasidone, Schizophrenia, 20/03/2014, 16, Authorised (updated)
13/06/2019 Human medicines European public assessment report (EPAR): Accofil, filgrastim, Neutropenia, 17/09/2014, Biosimilar, 10, Authorised (updated)
13/06/2019 Human medicines European public assessment report (EPAR): Leflunomide Zentiva (previously Leflunomide Winthrop), leflunomide, Arthritis, Rheumatoid, Arthritis, Psoriatic, 08/01/2010, 15, Authorised (updated)
13/06/2019 Human medicines European public assessment report (EPAR): Cystadane, Betaine anhydrous, Homocystinuria, 14/02/2007, 13, Authorised (updated)
13/06/2019 Human medicines European public assessment report (EPAR): Pemetrexed Hospira, pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 19/11/2015, Generic, 7, Authorised (updated)
13/06/2019 Veterinary medicines European public assessment report (EPAR): Leucogen, purified p45 FeLV-envelope antigen, 17/06/2009, 7, Authorised (updated)
13/06/2019 Human medicines European public assessment report (EPAR): Onivyde, irinotecan hydrochloride trihydrate, Pancreatic Neoplasms, 14/10/2016, Orphan, 3, Authorised (updated)
13/06/2019 Human medicines European public assessment report (EPAR): Mvasi, bevacizumab, Carcinoma, Renal Cell, Peritoneal Neoplasms, Ovarian Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Fallopian Tube Neoplasms, 14/01/2018, Additional monitoring, Biosimilar, 4, Authorised (updated)
13/06/2019 Human medicines European public assessment report (EPAR): Truxima, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Wegener Granulomatosis, Leukemia, Lymphocytic, Chronic, B-Cell, Microscopic Polyangiitis, 17/02/2017, Additional monitoring, Biosimilar, 8, Authorised (updated)
13/06/2019 Human medicines European public assessment report (EPAR): Translarna, Ataluren, Muscular Dystrophy, Duchenne, 31/07/2014, Orphan, Additional monitoring, Conditional approval, 11, Authorised (updated)
13/06/2019 Veterinary medicines European public assessment report (EPAR): Leucofeligen FeLV/RCP, live feline calicivirus (strain F9) / live feline viral rhinotracheitis virus (strain F2) / live feline panleucopenia virus, purified p45 feline leukaemia virus envelope antigen, 24/06/2009, 7, Authorised (updated)
12/06/2019 Veterinary medicines European public assessment report (EPAR): Nobivac LeuFel, purified Rp-45 FeLV-envelope antigen, 06/11/2017, 2, Authorised (updated)
12/06/2019 Veterinary medicines European public assessment report (EPAR): Suvaxyn PCV, porcine circovirus recombinant virus (CPCV) 1-2, inactivated, 24/07/2009, 13, Authorised (updated)
12/06/2019 Other: Article 57 product data (updated)
12/06/2019 Veterinary medicines European public assessment report (EPAR): Baycox Iron, Iron(iii) ion / toltrazuril, 20/05/2019, Authorised
12/06/2019 Human medicines European public assessment report (EPAR): Zessly, infliximab, Arthritis, Psoriatic, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, 18/05/2018, Additional monitoring, Biosimilar, 3, Authorised (updated)
12/06/2019 Human medicines European public assessment report (EPAR): Irbesartan/Hydrochlorothiazide Teva, irbesartan, hydrochlorothiazide, Hypertension, 26/11/2009, Generic, 16, Authorised (updated)
12/06/2019 Human medicines European public assessment report (EPAR): Alpivab, Peramivir, Influenza, Human, 13/04/2018, Additional monitoring, 1, Authorised (updated)
12/06/2019 Human medicines European public assessment report (EPAR): Irbesartan Teva, irbesartan, Hypertension, 30/10/2009, Generic, 11, Authorised (updated)
11/06/2019 Human medicines European public assessment report (EPAR): Revlimid, lenalidomide, Multiple Myeloma, Lymphoma, Mantle-Cell, Myelodysplastic Syndromes, 14/06/2007, Orphan, Additional monitoring, 38, Authorised (updated)
11/06/2019 European Medicines Agency (EMA) and European Union (EU) payer community meeting , Zorginstituut Nederland, Diemen, The Netherlands, from 18/06/2019 to 18/06/2019
11/06/2019 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 27 – 29 May 2019
11/06/2019 Human medicines European public assessment report (EPAR): Glivec, imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Gastrointestinal Stromal Tumors, Dermatofibrosarcoma, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hypereosinophilic Syndrome, 07/11/2001, Additional monitoring, 35, Authorised (updated)
11/06/2019 Human medicines European public assessment report (EPAR): Tesavel, sitagliptin, Diabetes Mellitus, Type 2, 10/01/2008, 21, Authorised (updated)
11/06/2019 Human medicines European public assessment report (EPAR): Modigraf, tacrolimus, Graft Rejection, 15/05/2009, 12, Authorised (updated)
11/06/2019 Agenda: Agenda - PRAC draft agenda of meeting 11-14 June 2019
11/06/2019 News and press releases: Two additional countries to benefit from EU-US mutual recognition agreement for inspections
11/06/2019 Mutual recognition agreements (MRA) (updated)
11/06/2019 Other: Questions and answers on the impact of mutual recognition agreement between the European Union and the United States as of 10 June 2019 (updated)
11/06/2019 Human medicines European public assessment report (EPAR): Flixabi, infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis, 26/05/2016, Additional monitoring, Biosimilar, 9, Authorised (updated)
11/06/2019 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 13-16 May 2019 PRAC
11/06/2019 Other: List of signals discussed at the PRAC since September 2012 (updated)
11/06/2019 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 13-16 May 2019 PRAC meeting
07/06/2019 Human medicines European public assessment report (EPAR): Dectova, Zanamivir, Influenza, Human, Additional monitoring, Authorised
07/06/2019 Veterinary medicines European public assessment report (EPAR): Afoxolaner Merial, afoxolaner, 20/05/2019, Authorised
07/06/2019 Human medicines European public assessment report (EPAR): Miglustat Gen.Orph, miglustat, Gaucher Disease, 09/11/2017, Generic, 3, Authorised (updated)
07/06/2019 Orphan designation: Recombinant human hepatocarcinoma-intestine-pancreas, pancreatic associated protein for the: Treatment of acute liver failure, 11/02/2009, Positive (updated)
07/06/2019 Q&A: Transfer (updated)
07/06/2019 Q&A: Renewals (updated)
07/06/2019 Q&A: Post-authorisation measures (recommendations, conditions and specific obligations) (updated)
07/06/2019 Q&A: Changing the (invented) name of a centrally authorised medicinal product (updated)
07/06/2019 Plasma-master-file certifications (updated)
06/06/2019 Periodic safety update single assessment: Atorvastatin/ezetimibe: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation- PSUSA/00010385/201807
06/06/2019 Periodic safety update single assessment: Atorvastatin/ezetimibe: List of nationally authorised products - PSUSA/00010385/201807
06/06/2019 News and press releases: EMA closed 10 June 2019
06/06/2019 Human medicines European public assessment report (EPAR): Gardasil, human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections, Uterine Cervical Dysplasia, Condylomata Acuminata, Immunization, 20/09/2006, 40, Authorised (updated)
06/06/2019 News and press releases: Strengthening engagement between EMA and general practitioners
06/06/2019 Healthcare professionals (updated)
06/06/2019 Human medicines European public assessment report (EPAR): Xigduo, metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, 16/01/2014, 13, Authorised (updated)
06/06/2019 Newsletter: Human medicines highlights - June 2019
06/06/2019 Regulatory and procedural guideline: Strenghthening collaboration between EMA and general practioners / family physicians
06/06/2019 Report: List of products granted eligibility to PRIME (updated)
06/06/2019 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 27-29 May 2019
05/06/2019 Human medicines European public assessment report (EPAR): Vizimpro, dacomitinib monohydrate, Carcinoma, Non-Small-Cell Lung, 02/04/2019, Additional monitoring, Authorised
05/06/2019 Human medicines European public assessment report (EPAR): Xermelo, telotristat etiprate, Carcinoid Tumor, Neuroendocrine Tumors, 17/09/2017, Orphan, Additional monitoring, 5, Authorised (updated)
05/06/2019 Human medicines European public assessment report (EPAR): Ebymect, dapagliflozin propanediol monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2, 15/11/2015, 10, Authorised (updated)
05/06/2019 Human medicines European public assessment report (EPAR): Xgeva, denosumab, Fractures, Bone, Neoplasm Metastasis, 13/07/2011, 17, Authorised (updated)
05/06/2019 Regulatory and procedural guideline: Member states contact points for translations review (updated)
05/06/2019 Human medicines European public assessment report (EPAR): Efficib, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 15/07/2008, 25, Authorised (updated)
05/06/2019 Human medicines European public assessment report (EPAR): Farydak, panobinostat lactate anhydrous, Multiple Myeloma, 28/08/2015, Orphan, Additional monitoring, 6, Authorised (updated)
05/06/2019 Human medicines European public assessment report (EPAR): Tremfya, guselkumab, Psoriasis, 10/11/2017, Additional monitoring, 2, Authorised (updated)
05/06/2019 Human medicines European public assessment report (EPAR): Lemtrada, alemtuzumab, Multiple Sclerosis, 12/09/2013, Patient safety, 8, Authorised (updated)
05/06/2019 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
05/06/2019 Human medicines European public assessment report (EPAR): Kyprolis, carfilzomib, Multiple Myeloma, 19/11/2015, Orphan, Additional monitoring, 14, Authorised (updated)
05/06/2019 Human medicines European public assessment report (EPAR): Hemlibra, Emicizumab, Hemophilia A, 23/02/2018, Accelerated assessment, Additional monitoring, 5, Authorised (updated)
05/06/2019 Minutes: Minutes of the COMP meeting 19-21 March 2019
05/06/2019 Minutes: Minutes of the CAT meeting 20-22 March 2019
05/06/2019 Report: Small and medium-sized enterprise (SME) Office annual report 2018
05/06/2019 Orphan designation: adeno-associated viral vector serotype hu68 containing the human SMN1 gene for the: Treatment of spinal muscular atrophy, 24/08/2018, Positive (updated)
05/06/2019 Orphan designation: 3-pentylbenzeneacetic acid sodium salt for the: Treatment of Alström syndrome, 12/01/2017, Positive (updated)
05/06/2019 Orphan designation: 3-pentylbenzeneacetic acid sodium salt for the: Treatment of idiopathic pulmonary fibrosis, 09/10/2015, Positive (updated)
05/06/2019 Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt for the: Treatment of acute myeloid leukaemia, 24/08/2018, Positive (updated)
05/06/2019 Human medicines European public assessment report (EPAR): Synjardy, empagliflozin, metformin, Diabetes Mellitus, Type 2, 27/05/2015, Additional monitoring, 14, Authorised (updated)
04/06/2019 Human medicines European public assessment report (EPAR): Nivestim, filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer, 07/06/2010, Biosimilar, 19, Authorised (updated)
04/06/2019 Human medicines European public assessment report (EPAR): Dafiro HCT, Amlodipine besylate, valsartan, hydrochlorothiazide, Hypertension, 03/11/2009, 17, Authorised (updated)
04/06/2019 Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Melanoma, Hodgkin Disease, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, 19/06/2015, Additional monitoring, 25, Authorised (updated)
04/06/2019 Human medicines European public assessment report (EPAR): Bexsero, outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254), recombinant Neisseria meningitidis group B fHbp fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B NHBA fusion protein, Meningitis, Meningococcal, 13/01/2013, 22, Authorised (updated)
04/06/2019 Human medicines European public assessment report (EPAR): Ivabradine Accord, ivabradine hydrochloride, Angina Pectoris, Heart Failure, 22/05/2017, Generic, 3, Authorised (updated)
04/06/2019 Human medicines European public assessment report (EPAR): Intelence, Etravirine, HIV Infections, 28/08/2008, 23, Authorised (updated)
04/06/2019 Human medicines European public assessment report (EPAR): Talmanco (previously Tadalafil Generics), tadalafil, Hypertension, Pulmonary, 09/01/2017, Generic, 3, Authorised (updated)
04/06/2019 Human medicines European public assessment report (EPAR): Cervarix, human papillomavirus1 type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections, Uterine Cervical Dysplasia, Immunization, 20/09/2007, 32, Authorised (updated)
04/06/2019 How to prepare and review a summary of product characteristics (updated)
04/06/2019 Human medicines European public assessment report (EPAR): Stayveer, bosentan monohydrate, Hypertension, Pulmonary, Scleroderma, Systemic, 24/06/2013, 8, Authorised (updated)
04/06/2019 Human medicines European public assessment report (EPAR): Cayston, aztreonam lysine, Cystic Fibrosis, Respiratory Tract Infections, 21/09/2009, Orphan, 17, Authorised (updated)
04/06/2019 Human medicines European public assessment report (EPAR): Prevymis, Letermovir, Cytomegalovirus Infections, 08/01/2018, Orphan, Additional monitoring, 3, Authorised (updated)
03/06/2019 Hexaxim H-W-2495 (updated)
03/06/2019 Referral: Syner-Kinase and associated names , urokinase , Article 29(4) referrals, European Commission final decision, 28/02/2019, 16/05/2019, 03/06/2019 (updated)
03/06/2019 Human medicines European public assessment report (EPAR): Hexyon, Diphtheria toxoid adsorbed on aluminium hydroxide, hydrated, filamentous Haemagglutinin, haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate), hepatitis B surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (mahoney strain) produced on vero cells, poliovirus (inactivated) type 2 (mef-1 strain) produced on vero cells, poliovirus (inactivated) type 3 (saukett strain) produced on vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria, 17/04/2013, 22/02/2013, 19, Authorised (updated)
03/06/2019 Orphan designation: Fenfluramine hydrochloride for the: Treatment of Lennox-Gastaut syndrome, 27/02/2017, Positive (updated)
03/06/2019 Human medicines European public assessment report (EPAR): Hexacima, diphtheria toxoid / tetanus toxoid, two-component acellular pertussis (pertussis toxoid and filamentous haemagglutinin ) / inactivated poliomyelitis virus types 1,2 and 3 / Haemophilus influenzae type-b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein, hepatitis-B surface antigen, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria, 17/04/2013, 22/02/2013, 18, Authorised (updated)
03/06/2019 Human medicines European public assessment report (EPAR): Karvezide, irbesartan, hydrochlorothiazide, Hypertension, 16/10/1998, 36, Authorised (updated)
03/06/2019 Human medicines European public assessment report (EPAR): Bondronat, ibandronic acid, Hypercalcemia, Breast Neoplasms, Neoplasm Metastasis, Fractures, Bone, 25/06/1996, 27, Authorised (updated)
03/06/2019 Orphan designation: Fenfluramine hydrochloride for the: Treatment of Dravet syndrome, 16/01/2014, Positive (updated)
03/06/2019 Human medicines European public assessment report (EPAR): Trisenox, Arsenic trioxide, Leukemia, Promyelocytic, Acute, 05/03/2002, Orphan, 26, Authorised (updated)
03/06/2019 Medical devices (updated)
03/06/2019 News and press releases: Consultation on draft guideline on quality requirements for medical devices in combination products
03/06/2019 Scientific guideline: Draft guideline on the quality requirements for drug-device combinations
03/06/2019 Quality requirements for drug-device combinations
03/06/2019 Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene for the: Treatment of beta thalassaemia intermedia and major, 24/01/2013, Positive (updated)
03/06/2019 Human medicines European public assessment report (EPAR): Zynteglo, Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia, 29/05/2019, Orphan, Additional monitoring, Authorised
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