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, , , , 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, , , , 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, , , 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, , 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, , 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, , 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, , , , 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, , 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, , 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, , 4, Authorised (updated) |
09/03/2023 |
Human medicines European public assessment report (EPAR): Leflunomide medac, leflunomide, Arthritis, Rheumatoid, 27/07/2010, , 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, , 13, Authorised (updated) |
09/03/2023 |
Human medicines European public assessment report (EPAR): Rizmoic, Naldemedine tosilate, Constipation, 18/02/2019, , 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, , 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, , 14, Authorised (updated) |
08/03/2023 |
Human medicines European public assessment report (EPAR): Abiraterone Krka , abiraterone acetate, Prostatic Neoplasms, 24/06/2021, , 2, Authorised (updated) |
08/03/2023 |
Human medicines European public assessment report (EPAR): Fetcroja, cefiderocol sulfate tosilate, Gram-Negative Bacterial Infections, 23/04/2020, , 5, Authorised (updated) |
08/03/2023 |
Human medicines European public assessment report (EPAR): Senshio, ospemifene, Postmenopause, 14/01/2015, , 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, , 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, , , 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, , 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, , 14, Authorised (updated) |
07/03/2023 |
Human medicines European public assessment report (EPAR): SomaKit TOC, edotreotide, Neuroendocrine Tumors; Radionuclide Imaging, 08/12/2016, , 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, , 13, Authorised (updated) |
06/03/2023 |
Human medicines European public assessment report (EPAR): Veyvondi, vonicog alfa, von Willebrand Diseases, 31/08/2018, , 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, , 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, , 4, Authorised (updated) |
06/03/2023 |
Human medicines European public assessment report (EPAR): Temozolomide Sandoz, temozolomide, Glioma; Glioblastoma, 15/03/2010, , 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, , 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, , 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, , 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, , 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, , 49, Authorised (updated) |
02/03/2023 |
Human medicines European public assessment report (EPAR): Pemazyre, pemigatinib, Cholangiocarcinoma, 26/03/2021, , , , 5, Authorised (updated) |
02/03/2023 |
Human medicines European public assessment report (EPAR): Imjudo, Tremelimumab, Carcinoma, Hepatocellular, 20/02/2023, , Authorised (updated) |
02/03/2023 |
Human medicines European public assessment report (EPAR): Scemblix, asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 25/08/2022, , , 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, , 21, Authorised (updated) |
02/03/2023 |
Human medicines European public assessment report (EPAR): Vyndaqel, tafamidis, Amyloidosis, 16/11/2011, , , , 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, , 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, , 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, , , 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 |