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Date Content
16/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Evenity, Romosozumab, PM: decision on the application for modification of an agreed PIP, P/0551/2021 (updated)
16/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan, PM: decision on the application for modification of an agreed PIP, P/0480/2021 (updated)
16/03/2023 Referral: Gelisia and associated names , timolol maleate, Genoptol,Gelisia,Timolol sifi 1 mg/g gel oftalmico, Article 29(4) referrals, European Commission final decision, 15/12/2022, 27/02/2023, 16/03/2023 (updated)
16/03/2023 Human Medicines (updated)
16/03/2023 Other: Organisation chart: Human Medicines (updated)
16/03/2023 Referral: Pseudoephedrine-containing medicinal products , pseudoephedrine, Article 31 referrals, Procedure started, 16/03/2023 (updated)
16/03/2023 Report: Medicinal products for human use: monthly figures - February 2023
15/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Jakavi, Ruxolitinib (phosphate), PM: decision on the application for modification of an agreed PIP, P/0527/2021 (updated)
15/03/2023 Human medicines European public assessment report (EPAR): Elzonris, tagraxofusp, Lymphoma, 07/01/2021, Orphan, Additional monitoring, Exceptional circumstances, 6, Authorised (updated)
15/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Fycompa, perampanel, PM: decision on the application for modification of an agreed PIP, P/0521/2021 (updated)
15/03/2023 Human medicines European public assessment report (EPAR): Nordimet, Methotrexate, Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid, 18/08/2016, 18, Authorised (updated)
15/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Bilastine, PM: decision on the application for modification of an agreed PIP, P/0526/2021 (updated)
15/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Methoxyflurane, PM: decision on the application for modification of an agreed PIP, P/0525/2021 (updated)
15/03/2023 Other: Records of data processing activity (public) for the EMA intranet
15/03/2023 Human medicines European public assessment report (EPAR): NeoRecormon, epoetin beta, Kidney Failure, Chronic; Anemia; Cancer; Blood Transfusion, Autologous, 16/07/1997, 33, Authorised (updated)
15/03/2023 Supply shortage: Ozempic (semaglutide) supply shortage (updated)
15/03/2023 News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8 December 2022 (updated)
14/03/2023 Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 09:30 - 11:00 Amsterdam time (CET), from 15/03/2023 to 15/03/2023
14/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Xydalba, dalbavancin hydrochloride, PM: decision on the application for modification of an agreed PIP, P/0522/2021 (updated)
14/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Acetylcysteine,paracetamol,phenylephrine, W: decision granting a waiver in all age groups for all conditions or indications, P/0557/2021
14/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ramipril,amlodipine (as besylate), W: decision granting a waiver in all age groups for all conditions or indications, P/0513/2021
14/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Adagrasib, W: decision granting a waiver in all age groups for all conditions or indications, P/0511/2021
14/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Adavosertib, W: decision granting a waiver in all age groups for all conditions or indications, P/0512/2021
14/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin, W: decision granting a waiver in all age groups for all conditions or indications, P/0501/2021
14/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Humanised IgG2k Fc-modified bispecific antibody against CD3 and BCMA (PF-06863135), W: decision granting a waiver in all age groups for all conditions or indications, P/0564/2021
14/03/2023 Orphan designation: Autologous T-cells transduced with a lentiviral vector encoding a chimeric antigen receptor against CD7 for the: Treatment of acute lymphoblastic leukaemia, 09/12/2022, Positive (updated)
14/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Loncastuximab tesirine, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0400/2021 (updated)
14/03/2023 Human medicines European public assessment report (EPAR): Zinplava, bezlotoxumab, Enterocolitis, Pseudomembranous, 18/01/2017, 9, Authorised (updated)
14/03/2023 Direct healthcare professional communication (DHPC): Myalepta (metreleptin) 5.8 mg vial: shortage and mitigation plan, Active substance: Metreleptin, DHPC type: Medicine shortage, Last updated: 14/03/2023
14/03/2023 Template or form: Day 80 assessment report - New active substance status template - Rev. 03. 23 (updated)
14/03/2023 Template or form: CHMP and rapporteurs' joint assessment report on derogation applicable to similar orphan products - Rev. 03.23 (updated)
14/03/2023 Template or form: CHMP and Rapporteurs' assessment report template on Similarity Rev. 03.23 (updated)
14/03/2023 Other: Annex to the working arrangement between the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC)
14/03/2023 Report: Implementing measures under Article Art 115(5) of Regulation (EU) 2019/6 as regards the list of substances which are essential for the treatment of equine species and for which the withdrawal period for equine species shall be six months
14/03/2023 Human medicines European public assessment report (EPAR): Drovelis, drospirenone, estetrol monohydrate, Contraceptives, Oral, 19/05/2021, 3, Authorised (updated)
14/03/2023 Human medicines European public assessment report (EPAR): Ayvakyt, avapritinib, Gastrointestinal Stromal Tumors, 24/09/2020, Orphan, Additional monitoring, Conditional approval, 6, Authorised (updated)
14/03/2023 Other: Evaluation guide for good-manufacturing-practice regulatory compliance programme: Audit checklist (updated)
14/03/2023 Other: Annex to the evaluation guide for good-manufacturing-practice regulatory compliance programme: Audit checklist
14/03/2023 Human medicines European public assessment report (EPAR): Cablivi, Caplacizumab, Purpura, Thrombotic Thrombocytopenic, 30/08/2018, Orphan, Additional monitoring, 7, Authorised (updated)
13/03/2023 Other: Release notes - production release version 1.6.20 March 2023 - Veterinary Medicinal Products Regulation: Union Product Database
13/03/2023 Agenda: Agenda of the PRAC meeting 13-16 March 2023
13/03/2023 Periodic safety update single assessment: Bemiparin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000312/202204
13/03/2023 Periodic safety update single assessment: Bemiparin : List of nationally authorised medicinal products - PSUSA/00000312/202204
13/03/2023 Human medicines European public assessment report (EPAR): Invirase, saquinavir, HIV Infections, 03/10/1996, 50, Authorised (updated)
13/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): pembrolizumab,Vibostolimab, W: decision granting a waiver in all age groups for all conditions or indications, P/0485/2021
13/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): eplerenone,Furosemide, W: decision granting a waiver in all age groups for all conditions or indications, P/0488/2021
13/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Bordetella pertussis antigen: Filamentous Haemagglutinin,Bordetella pertussis antigen: Pertactin,Bordetella pertussis antigen: Pertussis toxoid,Inactivated poliovirus: type 1 (Mahoney strain),Inactivated poliovirus: type 2 (MEF-1 strain),Inactivated poliovirus: type 3 (Saukett strain),tetanus toxoid, W: decision granting a waiver in all age groups for all conditions or indications, P/0489/2021
13/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ofranergene obadenovec, W: decision granting a waiver in all age groups for all conditions or indications, P/0471/2021
13/03/2023 Orphan designation: Briquilimab for the: Treatment in haematopoietic stem cell transplantation, 09/12/2022, Positive
13/03/2023 Orphan designation: (2S)-4-[2-methoxyethyl-[4-(5,6,7,8-tetrahydro-1,8-naphthyridin-2-yl)butyl]amino]-2-(quinazolin-4-ylamino)butanoic acid for the: Treatment of idiopathic pulmonary fibrosis, 09/12/2022, Positive
13/03/2023 Orphan designation: Adeno-associated virus serotype rh79 containing the human OTC gene, adeno-associated virus serotype rh79 encoding a meganuclease for targeted editing of the human PCSK9 gene for the: Treatment of ornithine transcarbamylase deficiency, 09/12/2022, Positive
13/03/2023 Orphan designation: Potassium 2-chloro-3-(1-hydroxy-5,6,7,8-tetrahydronaphthalen-2-yl)-6-oxo-5-phenyl-6,7-dihydrothieno[2,3-b]pyridin-4-olate monohydrate for the: Treatment of adrenoleukodystrophy, 09/12/2022, Positive
13/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Pamrevlumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0508/2021
13/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): 2'-O-(2-methoxyethyl) phosphorothioate antisense oligonucleotide targeting CD49d RNA (ATL1102), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0504/2021
13/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Leniolisib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0556/2021
13/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Otenaproxesul, W: decision granting a waiver in all age groups for all conditions or indications, P/0472/2021
13/03/2023 Summary of opinion: Lagevrio, molnupiravir, 23/02/2023, Negative (updated)
13/03/2023 Human medicines European public assessment report (EPAR): Ivozall, clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/11/2019, Generic, 4, Authorised (updated)
13/03/2023 Orphan designation: Serplulimab for the: Treatment of small cell lung cancer, 09/12/2022, Positive
13/03/2023 Orphan designation: Duvelisib for the: Treatment of peripheral T-cell lymphoma, 09/12/2022, Positive
13/03/2023 Other: Clusters of Excellence Discussion Paper
13/03/2023 Big data (updated)
13/03/2023 Orphan designation: Utreloxastat for the: Treatment of amyotrophic lateral sclerosis, 09/12/2022, Positive
13/03/2023 Orphan designation: Recombinant adeno-associated virus Olig001 containing human aspartoacylase cDNA for the: Treatment of Canavan disease, 09/12/2022, Positive
13/03/2023 Orphan designation: Copper (64Cu) oxodotreotide for the: Diagnosis of neuroendocrine neoplasms, 09/12/2022, Positive
13/03/2023 Orphan designation: Iodine (124I) evuzamitide for the: Diagnosis of ATTR amyloidosis, 09/12/2022, Positive
13/03/2023 Orphan designation: Mebendazole for the: Treatment of autosomal dominant polycystic kidney disease, 09/12/2022, Positive
13/03/2023 Orphan designation: Upifitamab rilsodotin for the: Treatment of ovarian cancer, 09/12/2022, Positive
13/03/2023 Orphan designation: 16-base single stranded RNA targeting miR-23b linked to oleic acid for the: Treatment of myotonic disorders, 09/12/2022, Positive
13/03/2023 Agenda: Agenda of the HMPC meeting 13-15 March 2023
13/03/2023 Procurement (updated)
13/03/2023 Orphan designation: Panobinostat for the: Treatment of multiple myeloma, 08/11/2012, Positive (updated)
13/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Tamiflu, Oseltamivir (phosphate), PM: decision on the application for modification of an agreed PIP, P/0241/2021 (updated)
13/03/2023 Human medicines European public assessment report (EPAR): Adcetris, Brentuximab vedotin, Lymphoma, Non-Hodgkin; Hodgkin Disease, 25/10/2012, Orphan, 34, Authorised (updated)
13/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Brilique, ticagrelor, PM: decision on the application for modification of an agreed PIP, P/0175/2021 (updated)
13/03/2023 EMA multi-stakeholder workshop on qualification of novel methodologies , Online, from 17/04/2023 to 18/04/2023
13/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Eylea, aflibercept, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0115/2019 (updated)
13/03/2023 Other: PDCO meetings in 2023, 2024, 2025 and 2026
13/03/2023 Orphan designation: Lentiviral vector containing the human MYO7A gene for the: Treatment of retinitis pigmentosa in Usher syndrome 1B, 23/03/2010, Positive (updated)
13/03/2023 Orphan designation: Lentiviral vector containing the human ABCA4 gene for the: Treatment of Stargardt's disease, 02/02/2010, Positive (updated)
13/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx, Secukinumab, PM: decision on the application for modification of an agreed PIP, P/0352/2017 (updated)
13/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx, Secukinumab, PM: decision on the application for modification of an agreed PIP, P/0372/2018 (updated)
13/03/2023 Direct healthcare professional communication (DHPC): Ozempic (semaglutide) solution for injection in pre-filled pen: supply shortage update, Active substance: semaglutide, DHPC type: Medicine shortage, Last updated: 13/03/2023 (updated)
13/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Tivicay, Dolutegravir (DTG), PM: decision on the application for modification of an agreed PIP, P/0267/2021 (updated)
13/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Elonva, corifollitropin alfa, PM: decision on the application for modification of an agreed PIP, P/0143/2019 (updated)
13/03/2023 Orphan designation: clofazimine for the: Treatment of nontuberculous mycobacterial lung disease, 21/08/2019, Positive (updated)
10/03/2023 Periodic safety update single assessment: Venlafaxine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003104/202205
10/03/2023 Periodic safety update single assessment: Venlafaxine : List of nationally authorised medicinal products - PSUSA/00003104/202205
10/03/2023 Human medicines European public assessment report (EPAR): Nityr, nitisinone, Tyrosinemias, 26/07/2018, Generic, 4, Authorised (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Lutathera, lutetium (177Lu) oxodotreotide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0503/2021
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Neisseria meningitidis serogroup B Protein-based active substance,Recombinant Neisseria meningitidis serogroup B protein 1,Recombinant Neisseria meningitidis serogroup B protein 2,Recombinant Neisseria meningitidis serogroup B protein 3, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0473/2021
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain (BI 456906), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0500/2021
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Exebacase, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0537/2021
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Magrolimab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0531/2021
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): 2’-O-(2-methoxyethyl) modified antisense oligonucleotide targeting glial fibrillary acidic protein pre-mRNA (ION373), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0539/2021
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Molnupiravir, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0553/2021
10/03/2023 Human medicines European public assessment report (EPAR): Ebvallo, Tabelecleucel, Lymphoproliferative Disorders, 16/12/2022, Orphan, Additional monitoring, Exceptional circumstances, 2, Authorised (updated)
10/03/2023 Newsletter: CTIS newsflash - 10 March 2023
10/03/2023 Other: European Medicines Agency’s data protection notice for the European Union (EU) Metadata Catalogue
10/03/2023 Human medicines European public assessment report (EPAR): Ronapreve, casirivimab, imdevimab, COVID-19 virus infection, 12/11/2021, Additional monitoring, 3, Authorised (updated)
10/03/2023 News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 February 2023 (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Afstyla, lonoctocog alfa, PM: decision on the application for modification of an agreed PIP, P/0329/2019 (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): cerliponase alfa, PM: decision on the application for modification of an agreed PIP, P/0248/2016 (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Turoctocog alfa pegol, PM: decision on the application for modification of an agreed PIP, P/0142/2017 (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Revestive, teduglutide, PM: decision on the application for modification of an agreed PIP, P/0479/2020 (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): citric acid (as citric acid anhydrous),macrogol 4000,potassium chloride,simeticone,sodium chloride,sodium citrate,sodium sulfate (as sodium sulfate anhydrous), PM: decision on the application for modification of an agreed PIP, P/0134/2021 (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Opdivo, nivolumab, PM: decision on the application for modification of an agreed PIP, P/0432/2020 (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Idelvion, albutrepenonacog alfa, PM: decision on the application for modification of an agreed PIP, P/0031/2020 (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Human-cell-line recombinant human factor VIII (human-cl rhFVIII),Human Coagulation Factor VIII (rDNA), PM: decision on the application for modification of an agreed PIP, P/0014/2020 (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Zerbaxa, Ceftolozane,tazobactam, PM: decision on the application for modification of an agreed PIP, P/0436/2020 (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Cotellic, Cobimetinib, PM: decision on the application for modification of an agreed PIP, P/0119/2021 (updated)
10/03/2023 Orphan designation: 5-aminolevulinic acid for the: Treatment of glioma, 12/01/2017, Positive (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Lamzede, velmanase alfa, PM: decision on the application for modification of an agreed PIP, P/0407/2020 (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Tecfidera, dimethyl fumarate, PM: decision on the application for modification of an agreed PIP, P/0177/2020 (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Iblias, octocog alfa, PM: decision on the application for modification of an agreed PIP, P/0060/2018 (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Trecondi, Treosulfan, PM: decision on the application for modification of an agreed PIP, P/0346/2020 (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin, PM: decision on the application for modification of an agreed PIP, P/0013/2021 (updated)
10/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Bydureon, exenatide, PM: decision on the application for modification of an agreed PIP, P/0064/2021 (updated)
10/03/2023 Regulatory and procedural guideline: Guideline on computerised systems and electronic data in clinical trials
10/03/2023 Other: Article 57 product data (updated)
10/03/2023 European Medicines Agency veterinary medicines info day 2023 , Online, from 16/02/2023 to 17/02/2023 (updated)
09/03/2023 Human medicines European public assessment report (EPAR): Cosentyx, Secukinumab, Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing, 14/01/2015, 30, Authorised (updated)
09/03/2023 HMA/EMA multi-stakeholder workshop on shortages , Online, 09:00 - 16:45 Amsterdam time (CET), from 01/03/2023 to 02/03/2023 (updated)
09/03/2023 Human medicines European public assessment report (EPAR): Caprelsa, Vandetanib, Thyroid Neoplasms, 16/02/2012, Conditional approval, 24, Authorised (updated)
09/03/2023 Periodic safety update single assessment: Esomeprazole / naproxen : CMDh scientific conclusions, amendments to product information and implementation timetable - PSUSA/00001270/202204
09/03/2023 Periodic safety update single assessment: Esomeprazole / naproxen : List of nationally authorised medicinal products - PSUSA/00001270/202204
09/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): autologous CD34+ hematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0549/2021
09/03/2023 Human medicines European public assessment report (EPAR): Hukyndra, adalimumab, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis, 15/11/2021, Biosimilar, 4, Authorised (updated)
09/03/2023 Human medicines European public assessment report (EPAR): Leflunomide medac, leflunomide, Arthritis, Rheumatoid, 27/07/2010, Generic, 18, Authorised (updated)
09/03/2023 Human medicines European public assessment report (EPAR): Circadin, melatonin, Sleep Initiation and Maintenance Disorders, 29/06/2007, 33, Authorised (updated)
09/03/2023 Human medicines European public assessment report (EPAR): Omidria, ketorolac, phenylephrine, Lens Implantation, Intraocular; Pain, Postoperative, 28/07/2015, 7, Authorised (updated)
09/03/2023 Work programme: EudraVigilance Expert Working Group (EV-EWG) work programme 2023-2024
09/03/2023 Other: EMA reply to a letter from Members of the European Parliament, Mr Agius Saliba, Ms Ries, Mr Duda, Mr Biedroń, Ms Cerdas and Ms Metz concerning psychedelic-assisted therapies
09/03/2023 Human medicines European public assessment report (EPAR): Olanzapine Apotex, olanzapine, Schizophrenia; Bipolar Disorder, 10/06/2010, Generic, 13, Authorised (updated)
09/03/2023 Human medicines European public assessment report (EPAR): Rizmoic, Naldemedine tosilate, Constipation, 18/02/2019, Additional monitoring, 8, Authorised (updated)
09/03/2023 Listen and learn focus group meeting of the Quality Innovation Group , Online, from 13/03/2023 to 13/03/2023
09/03/2023 Human medicines European public assessment report (EPAR): Rivaroxaban Mylan, rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation, 12/11/2021, Generic, 1, Authorised (updated)
09/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Alpivab, Peramivir, PM: decision on the application for modification of an agreed PIP, P/0257/2021 (updated)
09/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): nivolumab,Relatlimab, PM: decision on the application for modification of an agreed PIP, P/0070/2021 (updated)
09/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab, PM: decision on the application for modification of an agreed PIP, P/0329/2021 (updated)
09/03/2023 Human medicines European public assessment report (EPAR): Arava, leflunomide, Arthritis, Rheumatoid; Arthritis, Psoriatic, 02/09/1999, 40, Authorised (updated)
09/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate), PM: decision on the application for modification of an agreed PIP, P/0093/2021 (updated)
09/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Cyclic pyranopterin monophosphate (fosdenopterin), PM: decision on the application for modification of an agreed PIP, P/0048/2021 (updated)
09/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Giotrif, afatinib, PM: decision on the application for modification of an agreed PIP, P/0184/2020 (updated)
09/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Epclusa, Sofosbuvir,velpatasvir, PM: decision on the application for modification of an agreed PIP, P/0150/2018 (updated)
09/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Genvoya, elvitegravir,cobicistat,emtricitabine,tenofovir alafenamide, PM: decision on the application for modification of an agreed PIP, P/0435/2020 (updated)
09/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 4 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 5 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 6A- diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 6B - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 7F - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 9V - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 14 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 18C - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 19A - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 19F - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 22F - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 23F - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 33F – diphtheria CRM197 conjugate (15-valent pneumococcal polysaccharide conjugate vaccine [V114]), PM: decision on the application for modification of an agreed PIP, P/0244/2019 (updated)
09/03/2023 Newsletter: Human medicines highlights - March 2023
09/03/2023 Report: Applications for new human medicines under evaluation by the CHMP: March 2023
08/03/2023 Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Epilepsy, 29/08/2008, 44, Authorised (updated)
08/03/2023 Human medicines European public assessment report (EPAR): Stivarga, regorafenib, Colorectal Neoplasms, 26/08/2013, 20, Authorised (updated)
08/03/2023 Other: Questions and Answers about the raw data proof-of-concept pilot for industry (updated)
08/03/2023 Other: Orphan medicines figures 2000-2022 (updated)
08/03/2023 Report: Annual report on the use of the special contribution for orphan medicinal products - 2022
08/03/2023 Template or form: Plasma master file timetable: 60-day - Period 2021-2024 (updated)
08/03/2023 Other: Committee for Advanced Therapies (CAT): work plan 2023
08/03/2023 Clinical Trials Regulation: progress on implementation (updated)
08/03/2023 Ninth industry stakeholder platform on research and development support , Online, from 05/12/2022 to 05/12/2022 (updated)
08/03/2023 Second Veterinary Big Data stakeholder forum , Online, 09:30 - 17:00 Amsterdam time (CET), from 23/11/2022 to 23/11/2022 (updated)
08/03/2023 Human medicines European public assessment report (EPAR): Prevymis, Letermovir, Cytomegalovirus Infections, 08/01/2018, Orphan, 14, Authorised (updated)
08/03/2023 Human medicines European public assessment report (EPAR): Abiraterone Krka , abiraterone acetate, Prostatic Neoplasms, 24/06/2021, Generic, 2, Authorised (updated)
08/03/2023 Human medicines European public assessment report (EPAR): Fetcroja, cefiderocol sulfate tosilate, Gram-Negative Bacterial Infections, 23/04/2020, Additional monitoring, 5, Authorised (updated)
08/03/2023 Human medicines European public assessment report (EPAR): Senshio, ospemifene, Postmenopause, 14/01/2015, Additional monitoring, 13, Authorised (updated)
08/03/2023 CHMP opinions on consultation procedures (updated)
08/03/2023 Other: LifeGlobal Media - Procedural steps and scientific information after initial consultation
08/03/2023 Human medicines European public assessment report (EPAR): Mulpleo (previously Lusutrombopag Shionogi), Lusutrombopag, Thrombocytopenia, 18/02/2019, Additional monitoring, 8, Authorised (updated)
08/03/2023 Referral: Rambis and associated names , ramipril, bisoprolol fumarate, Ralbior, Article 29(4) referrals, European Commission final decision, 15/12/2022, 15/02/2023, 08/03/2023 (updated)
07/03/2023 Human medicines European public assessment report (EPAR): Kauliv, teriparatide, Osteoporosis; Osteoporosis, Postmenopausal, 12/01/2023, Additional monitoring, Biosimilar, Authorised (updated)
07/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Repotrectinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0542/2021
07/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Verdiperstat, W: decision granting a waiver in all age groups for all conditions or indications, P/0523/2021
07/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): autologous CD34+ hematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the BCL11A gene, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0548/2021
07/03/2023 Human medicines European public assessment report (EPAR): Tecentriq, atezolizumab, Carcinoma, Transitional Cell; Carcinoma, Non-Small-Cell Lung; Urologic Neoplasms; Breast Neoplasms; Small Cell Lung Carcinoma, 20/09/2017, 21, Authorised (updated)
07/03/2023 Human medicines European public assessment report (EPAR): Paxlovid, nirmatrelvir, ritonavir, COVID-19 virus infection, 28/01/2022, 10, Authorised (updated)
07/03/2023 Human medicines European public assessment report (EPAR): Tevagrastim, filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer, 15/09/2008, Biosimilar, 16, Authorised (updated)
07/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin (tosatoxumab), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0563/2021
07/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Evenamide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0517/2021
07/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Efgartigimod alfa, W: decision granting a waiver in all age groups for all conditions or indications, P/0538/2021
07/03/2023 Orphan designation: Cannabidiol for the: Treatment of 22q11.2 deletion syndrome, 11/11/2022, Positive (updated)
07/03/2023 Orphan designation: Cannabidiol for the: Treatment of fragile X syndrome (FXS), 25/02/2022, Positive (updated)
07/03/2023 Orphan designation: 3,5-diamino-6-chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl)amino)ethoxy)phenyl)butyl)-carbamimidoyl)pyrazine-2-carboxamide, Sodium chloride solution 4.2% (w/v) for the: Treatment of primary ciliary dyskinesia, 16/11/2020, Positive (updated)
07/03/2023 Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka), capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms, 20/04/2012, Generic, 14, Authorised (updated)
07/03/2023 Human medicines European public assessment report (EPAR): SomaKit TOC, edotreotide, Neuroendocrine Tumors; Radionuclide Imaging, 08/12/2016, Orphan, 14, Authorised (updated)
07/03/2023 Human medicines European public assessment report (EPAR): Tivicay, dolutegravir, HIV Infections, 16/01/2014, 33, Authorised (updated)
07/03/2023 Template or form: Statement of quantitative composition (updated)
06/03/2023 Minutes: PDCO minutes of the 17-20 January 2023 meeting
06/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Marzeptacog alfa (activated), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0482/2021
06/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Marzeptacog alfa (activated), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0481/2021
06/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0474/2021
06/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Enspryng, satralizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0532/2021
06/03/2023 Human medicines European public assessment report (EPAR): Hemlibra, Emicizumab, Hemophilia A, 23/02/2018, Accelerated assessment, 13, Authorised (updated)
06/03/2023 Human medicines European public assessment report (EPAR): Veyvondi, vonicog alfa, von Willebrand Diseases, 31/08/2018, Additional monitoring, 6, Authorised (updated)
06/03/2023 Human medicines European public assessment report (EPAR): Cotellic, cobimetinib hemifumarate, Melanoma, 20/11/2015, 14, Authorised (updated)
06/03/2023 Human medicines European public assessment report (EPAR): Edistride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic, 09/11/2015, 21, Authorised (updated)
06/03/2023 Human medicines European public assessment report (EPAR): Forxiga, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic, 11/11/2012, 27, Authorised (updated)
06/03/2023 Periodic safety update single assessment: Levomethadone - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001855/202205
06/03/2023 Human medicines European public assessment report (EPAR): Empliciti, Elotuzumab, Multiple Myeloma, 11/05/2016, Accelerated assessment, 11, Authorised (updated)
06/03/2023 Periodic safety update single assessment: Methadone - List of nationally authorised medicinal products - PSUSA/00002004/202205
06/03/2023 Human medicines European public assessment report (EPAR): Ebymect, dapagliflozin propanediol monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2, 15/11/2015, 18, Authorised (updated)
06/03/2023 Human medicines European public assessment report (EPAR): Calquence, Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell, 05/11/2020, Additional monitoring, 4, Authorised (updated)
06/03/2023 Human medicines European public assessment report (EPAR): Temozolomide Sandoz, temozolomide, Glioma; Glioblastoma, 15/03/2010, Generic, 17, Withdrawn (updated)
06/03/2023 Human medicines European public assessment report (EPAR): Xigduo, metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, 16/01/2014, 19, Authorised (updated)
06/03/2023 Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Venous Thromboembolism, 15/09/2016, Biosimilar, 23, Authorised (updated)
06/03/2023 PRAC recommendation on signal: New product information wording : extracts from PRAC recommendations on signals adopted at the 6-9 February 2023 PRAC meeting
06/03/2023 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 6-9 February 2023 PRAC meeting
06/03/2023 Other: List of signals discussed at PRAC since September 2012 (updated)
06/03/2023 Human medicines European public assessment report (EPAR): Hepsera, adefovir dipivoxil, Hepatitis B, Chronic, 06/03/2003, 27, Withdrawn (updated)
03/03/2023 Human medicines European public assessment report (EPAR): Cayston, aztreonam lysine, Cystic Fibrosis; Respiratory Tract Infections, 21/09/2009, 20, Authorised (updated)
03/03/2023 Human medicines European public assessment report (EPAR): Prezista, darunavir, HIV Infections, 11/02/2007, 54, Authorised (updated)
03/03/2023 Human medicines European public assessment report (EPAR): Mysimba, bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight, 26/03/2015, Additional monitoring, 24, Authorised (updated)
03/03/2023 Plasma master file certificates (updated)
03/03/2023 Human medicines European public assessment report (EPAR): Efavirenz Teva, efavirenz, HIV Infections, 09/01/2012, Generic, 12, Authorised (updated)
03/03/2023 Other: Decision of the European Medicines Agency 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)
03/03/2023 Newsletter: CTIS newsflash - 3 March 2023
03/03/2023 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
02/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Human alpha1-proteinase inhibitor, W: decision granting a waiver in all age groups for all conditions or indications, P/0499/2021
02/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Vatiquinone, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0543/2021
02/03/2023 Periodic safety update single assessment: Mitoxantrone : List of nationally authorised medicinal products - PSUSA/00002076/202206
02/03/2023 Human medicines European public assessment report (EPAR): Aimovig, erenumab, Migraine Disorders, 26/07/2018, Additional monitoring, 9, Authorised (updated)
02/03/2023 Human medicines European public assessment report (EPAR): Revlimid, lenalidomide, Multiple Myeloma; Lymphoma, Mantle-Cell; Myelodysplastic Syndromes, 14/06/2007, Additional monitoring, 49, Authorised (updated)
02/03/2023 Human medicines European public assessment report (EPAR): Pemazyre, pemigatinib, Cholangiocarcinoma, 26/03/2021, Orphan, Additional monitoring, Conditional approval, 5, Authorised (updated)
02/03/2023 Human medicines European public assessment report (EPAR): Imjudo, Tremelimumab, Carcinoma, Hepatocellular, 20/02/2023, Additional monitoring, Authorised (updated)
02/03/2023 Human medicines European public assessment report (EPAR): Scemblix, asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 25/08/2022, Orphan, Additional monitoring, 2, Authorised (updated)
02/03/2023 Human medicines European public assessment report (EPAR): Kogenate Bayer, octocog alfa, Hemophilia A, 04/08/2000, 30, Withdrawn (updated)
02/03/2023 Human medicines European public assessment report (EPAR): Maviret, glecaprevir, pibrentasvir, Hepatitis C, Chronic, 26/07/2017, Accelerated assessment, 21, Authorised (updated)
02/03/2023 Human medicines European public assessment report (EPAR): Vyndaqel, tafamidis, Amyloidosis, 16/11/2011, Orphan, Additional monitoring, Exceptional circumstances, 25, Authorised (updated)
02/03/2023 Task Forces (updated)
02/03/2023 Other: Organisation chart: Task Forces (updated)
02/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Fasenra, benralizumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0497/2021
02/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx, Secukinumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0560/2021
02/03/2023 Other: Organisation chart: Administration and Corporate Management (updated)
02/03/2023 Administration and Corporate Management (updated)
02/03/2023 Opinion/decision on a Paediatric investigation plan (PIP): Plitidepsin, W: decision granting a waiver in all age groups for all conditions or indications, P/0544/2021
01/03/2023 Work programme: HMPC work plan 2023
01/03/2023 Opinions and letters of support on the qualification of novel methodologies for medicine development (updated)
01/03/2023 Other: Responses to list of issues - Stride velocity 95th centile as primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy
01/03/2023 Regulatory and procedural guideline: Draft Qualification Opinion for Stride velocity 95th centile as primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy
01/03/2023 Other: HMPC: overview of assessment work - priority list (updated)
01/03/2023 Human medicines European public assessment report (EPAR): Brintellix, Vortioxetine, Depressive Disorder, Major, 18/12/2013, 21, Authorised (updated)
01/03/2023 Orphan designation: arimoclomol citrate for the: Treatment of Niemann-Pick's disease, type C, 19/11/2014, Positive (updated)
01/03/2023 Human medicines European public assessment report (EPAR): MenQuadfi, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal, 18/11/2020, Additional monitoring, 8, Authorised (updated)
01/03/2023 PRIME: priority medicines (updated)
01/03/2023 Report: List of products granted eligibility to PRIME (updated)
01/03/2023 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 20-23 February 2023
01/03/2023 Human medicines European public assessment report (EPAR): Spravato, esketamine hydrochloride, Depressive Disorder, 18/12/2019, Additional monitoring, 7, Authorised (updated)
01/03/2023 Other: EVVet3 EVWeb Production – Release notes (updated)
01/03/2023 Article 5 procedure: Regulatory and procedural guidance (updated)
01/03/2023 Other: Orientation guide for patient representatives and healthcare professionals - EMA building (updated)
01/03/2023 Human medicines European public assessment report (EPAR): Revestive, teduglutide, Malabsorption Syndromes, 30/08/2012, Orphan, Additional monitoring, 21, Authorised (updated)
01/03/2023 Human medicines European public assessment report (EPAR): Entyvio, vedolizumab, Colitis, Ulcerative; Crohn Disease, 22/05/2014, 23, Authorised (updated)
01/03/2023 Withdrawn application: Garsun, artesunate, Date of withdrawal: 08/12/2022, Initial authorisation