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30/06/2020 Human medicines European public assessment report (EPAR): Velphoro, mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches, Hyperphosphatemia, Renal Dialysis, 26/08/2014, 7, Authorised (updated)
30/06/2020 Human medicines European public assessment report (EPAR): Siklos, hydroxycarbamide, Anemia, Sickle Cell, 29/06/2007, 18, Authorised (updated)
30/06/2020 Procurement activities 2019 (updated)
30/06/2020 Other: Annual list of contract modifications 2019 (new)
30/06/2020 Other: Annual list of contractors 2019 - contract values Euro 15,000 - 143,999 (new)
30/06/2020 Other: Annual list of specific contracts based on framework contracts - 2019 (new)
30/06/2020 News and press releases: EMA and Korean Ministry of Food and Drug Safety to share confidential COVID-19 information
30/06/2020 Regulatory and procedural guideline: Procedural advice for orphan medicinal product designation: Guidance for sponsors (updated)
30/06/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System , Lisbon, Portugal, from 07/10/2020 to 09/10/2020
30/06/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System , Vienna, Austria, from 28/10/2020 to 30/10/2020
30/06/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System , Munich, Germany, from 23/11/2020 to 25/11/2020
30/06/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System , Madrid, Spain, from 09/11/2020 to 11/11/2020
30/06/2020 ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System , Paris, France, from 30/11/2020 to 02/12/2020
30/06/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: June 2020 (new)
29/06/2020 Human medicines European public assessment report (EPAR): Akynzeo, netupitant, palonosetron hydrochloride, Vomiting, Cancer, Nausea, 27/05/2015, 8, Authorised (updated)
29/06/2020 Human medicines European public assessment report (EPAR): Nplate, romiplostim, Purpura, Thrombocytopenic, Idiopathic, 04/02/2009, 23, Authorised (updated)
29/06/2020 Other: Mandate, objectives and rules of procedure for the CVMP Immunologicals Working Party (IWP) (updated)
29/06/2020 Human medicines European public assessment report (EPAR): Kymriah, tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse, 22/08/2018, Orphan, Additional monitoring, 2, Authorised (updated)
29/06/2020 Human medicines European public assessment report (EPAR): Telzir, fosamprenavir calcium, HIV Infections, 12/07/2004, 44, Authorised (updated)
29/06/2020 Human medicines European public assessment report (EPAR): Capecitabine Teva, capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Patient safety, Generic, 12, Authorised (updated)
29/06/2020 Other: Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP) (updated)
29/06/2020 Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials (updated)
29/06/2020 Human medicines European public assessment report (EPAR): Spherox, spheroids of human autologous matrix-associated chondrocytes, Cartilage Diseases, 10/07/2017, Additional monitoring, 4, Authorised (updated)
29/06/2020 Minutes: Minutes of the CAT meeting 18-20 May 2020 (new)
29/06/2020 Scientific publications (updated)
29/06/2020 Veterinary medicines European public assessment report (EPAR): Stronghold Plus, selamectin, sarolaner, 08/02/2017, 3, Authorised (updated)
29/06/2020 Human medicines European public assessment report (EPAR): Grastofil, filgrastim, Neutropenia, 17/10/2013, Biosimilar, 12, Authorised (updated)
29/06/2020 Human medicines European public assessment report (EPAR): Idelvion, albutrepenonacog alfa, Hemophilia B, 11/05/2016, Orphan, Additional monitoring, 7, Authorised (updated)
26/06/2020 Human medicines European public assessment report (EPAR): Epidyolex, Cannabidiol, Lennox Gastaut Syndrome, Epilepsies, Myoclonic, 19/09/2019, Orphan, 2, Authorised (updated)
26/06/2020 Human medicines European public assessment report (EPAR): Bondronat, ibandronic acid, Hypercalcemia, Breast Neoplasms, Neoplasm Metastasis, Fractures, Bone, 25/06/1996, 28, Authorised (updated)
26/06/2020 Human medicines European public assessment report (EPAR): Kineret, anakinra, Arthritis, Rheumatoid, 08/03/2002, 27, Authorised (updated)
26/06/2020 Human medicines European public assessment report (EPAR): Eviplera, emtricitabine, rilpivirine hydrochloride / tenofovir disoproxil fumarate, HIV Infections, 27/11/2011, 23, Authorised (updated)
26/06/2020 Human medicines European public assessment report (EPAR): Efient, prasugrel, Acute Coronary Syndrome, Angina, Unstable, Myocardial Infarction, 24/02/2009, 20, Authorised (updated)
26/06/2020 Human medicines European public assessment report (EPAR): Xermelo, telotristat etiprate, Carcinoid Tumor, Neuroendocrine Tumors, 17/09/2017, Orphan, Additional monitoring, 10, Authorised (updated)
26/06/2020 Human medicines European public assessment report (EPAR): Symkevi, tezacaftor, ivacaftor, Cystic Fibrosis, 31/10/2018, Orphan, Additional monitoring, 6, Authorised (updated)
26/06/2020 Human medicines European public assessment report (EPAR): Pregabalin Sandoz, pregabalin, Anxiety Disorders, Neuralgia, Epilepsy, 19/06/2015, Generic, 4, Authorised (updated)
26/06/2020 Human medicines European public assessment report (EPAR): Pradaxa, Dabigatran etexilate mesilate, Arthroplasty, Replacement, Venous Thromboembolism, 17/03/2008, Patient safety, 31, Authorised (updated)
26/06/2020 Other: Questions and answers on management of extraneous agents in immunological veterinary medicinal products (IVMPs) (new)
26/06/2020 Questions and answers on management of extraneous agents in immunological veterinary medicinal products (IVMPs)
26/06/2020 Human medicines European public assessment report (EPAR): ProQuad, virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella, Chickenpox, Rubella, Measles, Mumps, Immunization, 05/04/2006, 26, Authorised (updated)
26/06/2020 Human medicines European public assessment report (EPAR): Epivir, lamivudine, HIV Infections, 08/08/1996, 45, Authorised (updated)
26/06/2020 Referral: Leuprorelin-containing depot medicinal products , leuprorelin , Daronda,Depo-Eligard,Eligard,Eligard Depot,Eligard Mensua,Eligard Semestral,Eligard Trimestral,Elityran 1 Month Depot (Dps),Elityran 3 Month Depot (Dps),Enanton Depot Dual,Enanton Depot Set,Enantone,Enantone L.P,Enantone Lp,Enantone Monats-Depot,Ginecrin Depot,Klebrocid 3-Monats-Depot,Klebrocid Depot Zweikammerspritze,Leptoprol,Lerin,Leugon,Leuprex 3,Leuprol,Leuprolin Ratiopharm,Leuprone 1-Monatsdepot,Leuprone 3-Monatsdepot,Leuprorelin 1-Month Depot Gp-Pharm,Leuprorelin Hexal,Leuprorelin Sandoz,Leuprorelina Gp-Pharm,Leupro-Sandoz 1-Monats-Depot,Leupro-Sandoz 3-Monats-Depot,Leuprorelina Trimestral Sandoz,Leuprostin,Leuproreline Sandoz,Lucrin,Lucrin Depot,Lucrin Pds Depot,Lucrin Pds Depot 1 Maand,Lucrin Pds Depot 3 Maanden,Lucrin Pds Depot 6 Maanden,Lupron Depo,Lutrate 1 Month Depot,Lutrate 3 Month Depot,Lutrate Depo,Lutrate Depot,Lutrate Depot Trimestral,Politrate,Politrate Politrate Depot,Procren Depot,Procren Depot Pds,Procrin Mensual,Procrin Semestral,Procrin Trimestral,Prostap 3 Dcs,Prostap 6 Dcs,Prostap Sr Dcs,Prostaplant,Sixantone,Trenantone,Trenantone-Gyn,Zeulide,Елигард,Лутрат Депо, Article 31 referrals, CMDh position (consensus), 25/06/2020, 26/06/2020 (updated)
26/06/2020 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2020
26/06/2020 Summary of opinion: Zavicefta, ceftazidime / avibactam, 25/06/2020, Positive
26/06/2020 Summary of opinion: Methylthioninium chloride Cosmo, methylthioninium chloride, 25/06/2020, Positive
26/06/2020 Withdrawn application: Zemdri, plazomicin, Date of withdrawal: 16/06/2020, Initial authorisation
26/06/2020 Summary of opinion: Cosentyx, secukinumab, 25/06/2020, Positive
26/06/2020 Withdrawn application: Sondelbay, teriparatide, Date of withdrawal: 19/06/2020, Initial authorisation
26/06/2020 Summary of opinion: Aybintio, bevacizumab, 25/06/2020, Positive
26/06/2020 Summary of opinion: Idefirix, imlifidase, 25/06/2020, Positive
26/06/2020 Summary of opinion: Xolair, omalizumab, 25/06/2020, Positive
26/06/2020 Summary of opinion: Epclusa, sofosbuvir / velpatasvir, 25/06/2020, Positive
26/06/2020 Summary of opinion: Gencebok, caffeine citrate, 25/06/2020, Positive
26/06/2020 Summary of opinion: Turalio, pexidartinib, 25/06/2020, Negative
26/06/2020 Annex to CHMP highlights: Start of Union reviews - CHMP meeting of 22-25 June 2020 (new)
26/06/2020 Summary of opinion: Remsima, infliximab, 25/06/2020, Positive
26/06/2020 Withdrawn application: Xiidra, lifitegrast, Date of withdrawal: 18/06/2020, Initial authorisation
26/06/2020 Referral: Varilrix , live attenuated varicella virus (OKA strain) , Article 30 referrals, Procedure started, 25/06/2020
26/06/2020 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 22-25 June 2020 (new)
26/06/2020 Summary of opinion: Livogiva, teriparatide, 25/06/2020, Positive
26/06/2020 Summary of opinion: Qutavina, teriparatide, 25/06/2020, Positive
26/06/2020 News and press releases: New medicine for cystic fibrosis patients
26/06/2020 News and press releases: New treatment to enable kidney transplant in highly sensitised patients
26/06/2020 Summary of opinion: Kaftrio, elexacaftor / tezacaftor / ivacaftor, 25/06/2020, Positive
26/06/2020 Referral: Budesonide SUN , budesonide , Article 29(4) referrals, Opinion provided by Committee for Medicinal Products for Human Use, 25/06/2020, 26/06/2020 (updated)
26/06/2020 Veterinary medicines European public assessment report (EPAR): Tulissin, tulathromycin, 24/04/2020, Generic, Authorised
26/06/2020 Veterinary medicines European public assessment report (EPAR): Tulaven, tulathromycin, 24/04/2020, Generic, Authorised
26/06/2020 Orphan designation: Ciprofloxacin (liposomal) for the: Treatment of cystic fibrosis, 24/07/2009, Positive (updated)
26/06/2020 Human medicines European public assessment report (EPAR): Januvia, sitagliptin, Diabetes Mellitus, Type 2, 20/03/2007, 27, Authorised (updated)
26/06/2020 Human medicines European public assessment report (EPAR): Yescarta, axicabtagene ciloleucel, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, 23/08/2018, Orphan, Additional monitoring, 6, Authorised (updated)
26/06/2020 Veterinary medicines European public assessment report (EPAR): Loxicom, meloxicam, 10/02/2009, Generic, 15, Authorised (updated)
26/06/2020 Human medicines European public assessment report (EPAR): Exjade, deferasirox, beta-Thalassemia, Iron Overload, 28/08/2006, Additional monitoring, 44, Authorised (updated)
26/06/2020 Human medicines European public assessment report (EPAR): Kivexa, abacavir, lamivudine, HIV Infections, 16/12/2004, 31, Authorised (updated)
26/06/2020 Other: Emerging safety issues (ESI) contact points at the national competent authority (NCA) level (updated)
26/06/2020 Veterinary medicines European public assessment report (EPAR): Porcilis ColiClos, Clostridium perfringens type C / Escherichia coli F4ab / E. coli F4ac / E. coli F5 / E. coli F6 / E. coli LT, 14/06/2012, 5, Authorised (updated)
26/06/2020 Committee for Medicinal Products for Veterinary Use (CVMP): 18-20 May 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 18/05/2020 to 20/05/2020 (updated)
26/06/2020 Minutes: Minutes of the CVMP meeting of 18-20 May 2020 (new)
25/06/2020 News and press releases: First COVID-19 treatment recommended for EU authorisation
25/06/2020 Veterinary medicines European public assessment report (EPAR): Felisecto Plus, selamectin, sarolaner, 26/04/2019, 1, Authorised (updated)
25/06/2020 News and press releases: Emer Cooke nominated as new EMA Executive Director
25/06/2020 Human medicines European public assessment report (EPAR): Pregabalin Sandoz GmbH, pregabalin, Anxiety Disorders, Epilepsy, 19/06/2015, Generic, 5, Authorised (updated)
25/06/2020 How to prepare and review a summary of product characteristics (updated)
25/06/2020 Presentation: Presentation - Section 4.8: Undesirable effects (updated)
25/06/2020 Other: Scientific guidelines with summary-of-product-characteristics recommendations (updated)
25/06/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: March 2020 (new)
25/06/2020 Agenda: Agenda - Extraordinary Management Board meeting to nominate a new EMA Executive Director: 25 June 2020 (updated)
25/06/2020 Minutes: Minutes of the COMP meeting 18-20 May 2020 (new)
25/06/2020 eXtended EudraVigilance Medicinal Product Dictionary training course , Munich, Germany, from 26/11/2020 to 27/11/2020
25/06/2020 eXtended EudraVigilance Medicinal Product Dictionary training course , Online, from 30/09/2020 to 02/10/2020
25/06/2020 eXtended EudraVigilance Medicinal Product Dictionary training course , Online, from 21/10/2020 to 23/10/2020
25/06/2020 eXtended EudraVigilance Medicinal Product Dictionary training course , Online, from 14/12/2020 to 16/12/2020
25/06/2020 Supply shortage: Cinryze (C1 inhibitor, human) supply shortage (updated)
25/06/2020 Extraordinary Management Board meeting: 25 June 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 25/06/2020 to 25/06/2020
25/06/2020 Other: List of eligible industry stakeholder organisations (updated)
25/06/2020 Business hours and holidays (updated)
24/06/2020 Veterinary medicines European public assessment report (EPAR): Equisolon, Prednisolone, 12/03/2014, 5, Authorised (updated)
24/06/2020 Agenda: Agenda - PDCO agenda of the 23-26 June 2020 meeting (new)
24/06/2020 Human medicines European public assessment report (EPAR): Nilemdo, Bempedoic acid, Hypercholesterolemia, Dyslipidemias, 01/04/2020, Additional monitoring, Authorised (updated)
24/06/2020 Withdrawn application: Rituximab Mabion, rituximab, Date of withdrawal: 16/03/2020, Initial authorisation (updated)
24/06/2020 Withdrawn application: Rituximab Mabion, rituximab, Date of withdrawal: 16/03/2020, Initial authorisation (updated)
24/06/2020 Human medicines European public assessment report (EPAR): Avastin, bevacizumab, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Ovarian Neoplasms, Colorectal Neoplasms, Carcinoma, Renal Cell, 12/01/2005, 55, Authorised (updated)
24/06/2020 Committee for Medicinal Products for Human Use (CHMP): 28-30 April 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 28/04/2020 to 30/04/2020 (updated)
24/06/2020 Human medicines European public assessment report (EPAR): Bemrist Breezhaler, indacaterol, Mometasone furoate, Asthma, 30/05/2020, Authorised
24/06/2020 Minutes: Minutes of the CHMP meeting 28-30 April 2020 (new)
24/06/2020 Human medicines European public assessment report (EPAR): Elaprase, idursulfase, Mucopolysaccharidosis II, 08/01/2007, Additional monitoring, Exceptional circumstances, 20, Authorised (updated)
24/06/2020 Human medicines European public assessment report (EPAR): Lamivudine Teva, lamivudine, Hepatitis B, Chronic, 23/10/2009, Generic, 9, Authorised (updated)
24/06/2020 Human medicines European public assessment report (EPAR): Daxas, roflumilast, Pulmonary Disease, Chronic Obstructive, 05/07/2010, Additional monitoring, 14, Authorised (updated)
24/06/2020 Human medicines European public assessment report (EPAR): Deferasirox Mylan, deferasirox, Iron Overload, beta-Thalassemia, 26/09/2019, Generic, Authorised (updated)
24/06/2020 Recommendations on medication errors (updated)
24/06/2020 Human medicines European public assessment report (EPAR): Galafold, migalastat hydrochloride, Fabry Disease, 25/05/2016, Orphan, Additional monitoring, 10, Authorised (updated)
24/06/2020 News and press releases: Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines
24/06/2020 Human medicines European public assessment report (EPAR): Circadin, melatonin, Sleep Initiation and Maintenance Disorders, 29/06/2007, 31, Authorised (updated)
24/06/2020 Human medicines European public assessment report (EPAR): Pazenir, paclitaxel, Breast Neoplasms, 06/05/2019, Generic, 5, Authorised (updated)
24/06/2020 Human medicines European public assessment report (EPAR): Imvanex, modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine, 31/07/2013, Additional monitoring, Exceptional circumstances, 16, Authorised (updated)
24/06/2020 List of medicines under additional monitoring (updated)
24/06/2020 Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)
24/06/2020 Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)
24/06/2020 Human medicines European public assessment report (EPAR): Zoledronic acid medac, zoledronic acid monohydrate, Fractures, Bone, Cancer, 03/08/2012, Generic, 12, Authorised (updated)
24/06/2020 Human medicines European public assessment report (EPAR): Velmetia, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 16/07/2008, 27, Authorised (updated)
24/06/2020 Human medicines European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen), aripiprazole, Schizophrenia, Bipolar Disorder, 30/06/2015, Generic, 10, Authorised (updated)
23/06/2020 Regulatory and procedural guideline: Pharmacovigilance regulatory recommendations for centrally authorised veterinary medicinal products during 2020 (updated)
23/06/2020 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, 33, Authorised (updated)
23/06/2020 Orphan designation: Ex-vivo-expanded autologous human corneal epithelium-containing stem cells for the: Corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns, 07/11/2008, Positive (updated)
23/06/2020 Orphan designation: 2'-O-methyl phosphorothioate RNA oligonucleotide, 5'-m5CUGm5CUGm5CUGm5CUGm5CUGm5CUGm5CUG-3' for the: Treatment of Huntington’s disease, 12/02/2015, Positive (updated)
23/06/2020 Human medicines European public assessment report (EPAR): Trumenba, Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B, Meningitis, Meningococcal, 24/05/2017, Additional monitoring, 8, Authorised (updated)
23/06/2020 Veterinary medicines European public assessment report (EPAR): Comfortis, spinosad, 11/02/2011, 8, Authorised (updated)
23/06/2020 Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Module VIII Addendum I - Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev. 3) (new)
23/06/2020 Regulatory and procedural guideline: Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with revision 3 of Addendum I of Module VIII on requirements and recommendations for the submission of information on non-interventional post-authorisation safety (new)
23/06/2020 News and press releases: European regulators make recommendations drawing on lessons learnt from presence of nitrosamines in sartan medicines
23/06/2020 Overview of comments: Overview of comments received on recommendations in report on lessons learnt from presence of N-nitrosamine impurities in sartan medicines (new)
23/06/2020 Scientific guideline: Guideline on good pharmacovigilance practices (GVP) - Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev. 2) (updated)
23/06/2020 Nitrosamine impurities (updated)
23/06/2020 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: May 2020 (new)
23/06/2020 Report: Medicinal products for human use: monthly figures - May 2020 (new)
23/06/2020 Human medicines European public assessment report (EPAR): Fertavid, follitropin beta, Infertility, Hypogonadism, 19/03/2009, 12, Withdrawn (updated)
23/06/2020 Public Statement: Public statement on Fertavid: Withdrawal of the marketing authorisation in the European Union (new)
23/06/2020 News and press releases: Academia developing medicines for rare diseases to receive free EMA scientific advice
23/06/2020 Regulatory and procedural guideline: Explanatory note on general fees payable to the European Medicines Agency as of 19 June 2020 (new)
23/06/2020 Other: Decision of the Executive Director on fee reductions for designated orphan medicinal products (new)
23/06/2020 Scientific advice and protocol assistance (updated)
23/06/2020 Academia (updated)
23/06/2020 Other: From laboratory to patient: the journey of a centrally authorised medicine (updated)
23/06/2020 Availability of medicines (updated)
23/06/2020 Human medicines European public assessment report (EPAR): Atectura Breezhaler, indacaterol acetate, Mometasone furoate, Asthma, 30/05/2020, Authorised
23/06/2020 Human medicines European public assessment report (EPAR): Carmustine Obvius, carmustine, Hodgkin Disease, Lymphoma, Non-Hodgkin, 18/07/2018, Generic, 4, Authorised (updated)
23/06/2020 Medical devices (updated)
23/06/2020 Other: Policy 44: European Medicines Agency policy on the handling of competing interests of scientific committees’ members and experts (new)
23/06/2020 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 11-14 May 2020 PRAC meeting (new)
23/06/2020 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 May 2020 PRAC (new)
22/06/2020 Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop), irbesartan, Hypertension, 19/01/2007, 22, Authorised (updated)
22/06/2020 News and press releases: European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines
22/06/2020 Human medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Cystic Fibrosis, 22/07/2012, Orphan, Accelerated assessment, 23, Authorised (updated)
22/06/2020 Human medicines European public assessment report (EPAR): Firdapse (previously Zenas), amifampridine, Lambert-Eaton Myasthenic Syndrome, 23/12/2009, Additional monitoring, Exceptional circumstances, 18, Authorised (updated)
22/06/2020 Agenda: Agenda - CHMP agenda of the 22-25 June 2020 meeting (new)
22/06/2020 Human medicines European public assessment report (EPAR): Duavive, oestrogens conjugated, bazedoxifene, Postmenopause, 16/12/2014, 10, Authorised (updated)
22/06/2020 Human medicines European public assessment report (EPAR): Maviret, glecaprevir / pibrentasvir, Hepatitis C, Chronic, 26/07/2017, Accelerated assessment, Additional monitoring, 10, Authorised (updated)
22/06/2020 Other: Decision of EMA 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 (updated)
22/06/2020 Human medicines European public assessment report (EPAR): Cablivi, Caplacizumab, Purpura, Thrombotic Thrombocytopenic, 30/08/2018, Orphan, Additional monitoring, 3, Authorised (updated)
22/06/2020 Human medicines European public assessment report (EPAR): Vaxchora, vibrio cholerae, strain cvd 103-hgr, live, Cholera, 01/04/2020, Additional monitoring, 1, Authorised (updated)
22/06/2020 Regulatory and procedural guideline: Dates of 2021 Scientific Advice Working Party (SAWP) meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests (new)
19/06/2020 Human medicines European public assessment report (EPAR): Vizamyl, flutemetamol (18F), Radionuclide Imaging, Alzheimer Disease, 22/08/2014, 11, Authorised (updated)
19/06/2020 Human medicines European public assessment report (EPAR): Signifor, pasireotide, Acromegaly, Pituitary ACTH Hypersecretion, 24/04/2012, Orphan, 12, Authorised (updated)
19/06/2020 Human medicines European public assessment report (EPAR): Lamivudine Teva Pharma B.V., lamivudine, HIV Infections, 10/12/2009, Generic, 15, Authorised (updated)
19/06/2020 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 June 2020
19/06/2020 Summary of opinion: Bluevac BTV8, 18/06/2020, Positive
19/06/2020 Human medicines European public assessment report (EPAR): Elebrato Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 15/11/2017, Additional monitoring, 6, Authorised (updated)
19/06/2020 Human medicines European public assessment report (EPAR): Alecensa, alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung, 16/02/2017, Additional monitoring, 8, Authorised (updated)
19/06/2020 EPAR - All authorised presentations: Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations (updated)
18/06/2020 Other: Record of data processing activity relating to managed print and ancillary services (public) (updated)
18/06/2020 Human medicines European public assessment report (EPAR): Praluent, Alirocumab, Dyslipidemias, 23/09/2015, Additional monitoring, 14, Authorised (updated)
18/06/2020 Veterinary medicines European public assessment report (EPAR): Bravecto Plus, fluralaner, moxidectin, 08/05/2018, 4, Authorised (updated)
18/06/2020 Veterinary medicines European public assessment report (EPAR): Bravecto, fluralaner, 11/02/2014, 12, Authorised (updated)
18/06/2020 Human medicines European public assessment report (EPAR): Spectrila, asparaginase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/01/2016, Additional monitoring, 4, Authorised (updated)
18/06/2020 Veterinary medicines European public assessment report (EPAR): Porcilis PCV M Hyo, Porcine circovirus type 2 (PCV2) ORF2 subunit antigen, Mycoplasma hyopneumoniae J strain inactivated, 06/11/2014, 7, Authorised (updated)
18/06/2020 Periodic safety update single assessment: Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201905 (new)
18/06/2020 Human medicines European public assessment report (EPAR): Keytruda, Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, 17/07/2015, Additional monitoring, 27, Authorised (updated)
18/06/2020 Direct healthcare professional communication (DHPC): Myalepta (metreleptin): inconsistencies in the package leaflet , Active substance: Metreleptin, DHPC type: Quality defect, Last updated: 18/06/2020
18/06/2020 Direct healthcare professional communication (DHPC): Suboxone sublingual tablets (buprenorphine / naloxone): inaccurate Braille information on the carton for HU/CZ/SK pack, Active substance: Buprenorphine | Naloxone, DHPC type: Quality defect, Last updated: 18/06/2020
18/06/2020 News and press releases: International regulators stress value of safe and effective vaccines
17/06/2020 Withdrawn application: Fingolimod Mylan, fingolimod, Date of withdrawal: 08/05/2020, Initial authorisation (updated)
17/06/2020 Application withdrawal assessment report: Withdrawal assessment report for Fingolimod Mylan (new)
17/06/2020 Veterinary medicines European public assessment report (EPAR): Novem, meloxicam, 02/03/2004, 12, Authorised (updated)
17/06/2020 Veterinary medicines European public assessment report (EPAR): Metacam, meloxicam, 07/01/1998, 26, Authorised (updated)
17/06/2020 Periodic safety update single assessment: Isoflurane: List of nationally authorised medicinal products - PSUSA/00001786/201910 (new)
17/06/2020 Committee for Medicinal Products for Human Use (CHMP): 23-26 March 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 23/03/2020 to 26/03/2020 (updated)
17/06/2020 Minutes: Minutes of the CHMP meeting 23-26 March 2020 (new)
17/06/2020 Human medicines European public assessment report (EPAR): Multaq, dronedarone, Atrial Fibrillation, 25/11/2009, 14, Authorised (updated)
17/06/2020 Committee for Advanced Therapies (CAT): 17-19 June 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 17/06/2020 to 19/06/2020 (updated)
17/06/2020 Agenda: Agenda - CAT agenda of the 17-19 June 2020 meeting (new)
17/06/2020 Human medicines European public assessment report (EPAR): Refixia, Nonacog beta pegol, Hemophilia B, 02/06/2017, Additional monitoring, 1, Authorised (updated)
17/06/2020 Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa , Active substance: andexanet alfa, DHPC type: Safety signal, Last updated: 17/06/2020
17/06/2020 Human medicines European public assessment report (EPAR): Mepact, mifamurtide, Osteosarcoma, 06/03/2009, 16, Authorised (updated)
17/06/2020 Human medicines European public assessment report (EPAR): Talzenna, talazoparib, Breast Neoplasms, 20/06/2019, Additional monitoring, 1, Authorised (updated)
17/06/2020 Periodic safety update single assessment: Isoniazid: List of nationally authorised medicinal products - PSUSA/00001789/201911 (new)
17/06/2020 Periodic safety update single assessment: Tixocortol, chlorhexidine gluconate / tixocortol pivalate: List of nationally authorised medicinal products - PSUSA/00010333/201911 (new)
17/06/2020 Periodic safety update single assessment: Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/201911 (new)
17/06/2020 Human medicines European public assessment report (EPAR): Aripiprazole Zentiva, aripiprazole, Schizophrenia, Bipolar Disorder, 25/06/2015, Generic, 7, Authorised (updated)
17/06/2020 Human medicines European public assessment report (EPAR): Icandra (previously Vildagliptin / metformin hydrochloride Novartis), vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 30/11/2008, 21, Authorised (updated)
17/06/2020 Referral: Methocarbamol / paracetamol-containing medicinal products , methocarbamol/paracetamol , Robaxisal compuesto, Article 31 referrals, European Commission final decision, 26/03/2020, 09/06/2020, 17/06/2020 (updated)
17/06/2020 Human medicines European public assessment report (EPAR): Xelevia, sitagliptin, Diabetes Mellitus, Type 2, 21/03/2007, 29, Authorised (updated)
17/06/2020 Human medicines European public assessment report (EPAR): Prezista, darunavir, HIV Infections, 11/02/2007, 48, Authorised (updated)
17/06/2020 Human medicines European public assessment report (EPAR): Miglustat Gen.Orph, miglustat, Gaucher Disease, 09/11/2017, Generic, 6, Authorised (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 08/02/2018, Additional monitoring, Biosimilar, 8, Authorised (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Mulpleo (previously Lusutrombopag Shionogi), Lusutrombopag, Thrombocytopenia, 18/02/2019, Additional monitoring, 4, Authorised (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Karvea, irbesartan, Hypertension, 26/08/1997, 39, Authorised (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Descovy, emtricitabine, tenofovir alafenamide, HIV Infections, 21/04/2016, Additional monitoring, 16, Authorised (updated)
16/06/2020 Periodic safety update single assessment: Felbamate: List of nationally authorised medicinal products - PSUSA/00010155/201909 (new)
16/06/2020 Human medicines European public assessment report (EPAR): Farydak, panobinostat lactate anhydrous, Multiple Myeloma, 28/08/2015, Orphan, 9, Authorised (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Orencia, Abatacept, Arthritis, Psoriatic, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, 21/05/2007, 32, Authorised (updated)
16/06/2020 Veterinary medicines European public assessment report (EPAR): BTVPUR, bluetongue-virus serotype-1 antigen / bluetongue-virus serotype-8 antigen , 17/12/2010, 11, Authorised (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Pemetrexed Lilly, pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 14/09/2015, Generic, 5, Authorised (updated)
16/06/2020 Referral: Ulipristal acetate 5mg medicinal products , Ulipristal acetate , Article 31 referrals, Under evaluation, 16/06/2020 (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Isturisa, Osilodrostat phosphate, Cushing Syndrome, 09/01/2020, Orphan, Additional monitoring, 2, Authorised (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Kisqali, ribociclib succinate, Breast Neoplasms, 22/08/2017, Additional monitoring, 4, Authorised (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Defitelio, defibrotide, Hepatic Veno-Occlusive Disease, 18/10/2013, Orphan, Additional monitoring, Exceptional circumstances, 11, Authorised (updated)
16/06/2020 Veterinary medicines European public assessment report (EPAR): Neocolipor, E. coli F6 / E. coli field strain ag f41 / Recombinant e.coli ag k88 (or f4) (ab, ac, ad) / Recombinant e.coli ag k99 (or f5), 14/04/1998, 13, Authorised (updated)
16/06/2020 Veterinary medicines European public assessment report (EPAR): Porcilis PCV ID, porcine circovirus type 2 ORF2 subunit antigen, 28/08/2015, 2, Authorised (updated)
16/06/2020 Veterinary medicines European public assessment report (EPAR): Galliprant, grapiprant, 09/01/2018, 4, Authorised (updated)
16/06/2020 EPAR - Risk-management-plan summary: Actraphane : EPAR - Risk-management-plan summary (updated)
16/06/2020 EPAR - Risk-management-plan summary: Actrapid : EPAR - Risk-management-plan summary (updated)
16/06/2020 Other: Designated Medical Event (DME) list (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Olazax Disperzi, olanzapine, Schizophrenia, Bipolar Disorder, 10/12/2009, Generic, 12, Authorised (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Braftovi, Encorafenib, Melanoma, 19/09/2018, Additional monitoring, 4, Authorised (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Ikervis, ciclosporin, Corneal Diseases, 19/03/2015, 7, Authorised (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Epilepsy, 29/08/2008, 32, Authorised (updated)
16/06/2020 Periodic safety update single assessment: Calcium salts / colecalciferol: List of nationally authorised medicinal products - PSUSA/00010386/201910 (new)
16/06/2020 Periodic safety update single assessment: Fluticasone / salmeterol: List of nationally authorised medicinal products - PSUSA/00001455/201910 (new)
16/06/2020 Periodic safety update single assessment: 1-propanol / 2-propanol / orthophenylphenol: List of nationally authorised medicinal products - PSUSA/00010406/201910 (new)
16/06/2020 Frequently asked questions (updated)
16/06/2020 Periodic safety update single assessment: Corticorelin: List of nationally authorised medicinal products - PSUSA/00000876/201910 (new)
16/06/2020 Human medicines European public assessment report (EPAR): Janumet, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 16/07/2008, 18/02/2009, 25, Authorised (updated)
16/06/2020 EPAR - Risk-management-plan summary: Protaphane : EPAR - Risk-management-plan summary (updated)
16/06/2020 EPAR - Risk-management-plan summary: Mixtard : EPAR - Risk-management-plan summary (updated)
16/06/2020 EPAR - Risk-management-plan summary: Insulatard : EPAR - Risk-management-plan summary (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Yellox, bromfenac sodium sesquihydrate, Pain, Postoperative, Ophthalmologic Surgical Procedures, 18/05/2011, 9, Authorised (updated)
16/06/2020 Other: Working arrangement between EMA, Directorate-General Health and Food Safety (DG SANTE) and Department of Health Canada (Health Canada) (new)
16/06/2020 Human medicines European public assessment report (EPAR): Ivemend, fosaprepitant, Vomiting, Cancer, 11/01/2008, 22, Authorised (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Oncaspar, pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/01/2016, Additional monitoring, 11, Authorised (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Sancuso, granisetron, Vomiting, Cancer, 20/04/2012, 13, Authorised (updated)
16/06/2020 Canada (updated)
16/06/2020 Human medicines European public assessment report (EPAR): Kyprolis, carfilzomib, Multiple Myeloma, 19/11/2015, Orphan, Accelerated assessment, Additional monitoring, 16, Authorised (updated)
16/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Simponi, Golimumab, PM: decision on the application for modification of an agreed PIP, P/0065/2018 (updated)
16/06/2020 Template or form: CHMP and Rapporteurs' assessment report template on Similarity rev. 06.20 (updated)
16/06/2020 Periodic safety update single assessment: Timolol (systemic use): List of nationally authorised medicinal products - PSUSA/00010432/201910 (new)
16/06/2020 Management Board meeting: 11 June 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 11/06/2020 to 11/06/2020 (updated)
16/06/2020 Report: Summary of transfers of appropriations in budget 2020 - Issues for consideration - Management Board meeting of 11 June 2020 (new)
16/06/2020 Other: Outcome of written procedures finalised during the period from 21 February 2020 to 26 May 2020 (new)
16/06/2020 Agenda: Agenda - CVMP agenda of the 16-18 June 2020 meeting (new)
16/06/2020 Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 June 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 16/06/2020 to 18/06/2020 (updated)
15/06/2020 News and press releases: Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #4