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Date Content
28/02/2023 Leaflet: Leaflet - Orphan medicines in the EU
28/02/2023 Work programme: 2023 work plan for the Quality Innovation Group (QIG)
28/02/2023 Direct healthcare professional communication (DHPC): Caprelsa (vandetanib): Restriction of indication, Active substance: Vandetanib, DHPC type: Restriction of indication, Last updated: 28/02/2023
28/02/2023 Human medicines European public assessment report (EPAR): Ivabradine Anpharm, ivabradine, Angina Pectoris; Heart Failure, 08/09/2015, 9, Authorised
27/02/2023 Human medicines European public assessment report (EPAR): Temozolomide Hexal, temozolomide, Glioma; Glioblastoma, 15/03/2010, Generic, 17, Withdrawn
27/02/2023 Human medicines European public assessment report (EPAR): Mekinist, trametinib, Melanoma, 30/06/2014, 29, Authorised
27/02/2023 Human medicines European public assessment report (EPAR): Ferriprox, Deferiprone, beta-Thalassemia; Iron Overload, 25/08/1999, 32, Authorised
27/02/2023 Human medicines European public assessment report (EPAR): Ikervis, ciclosporin, Corneal Diseases, 19/03/2015, 10, Authorised
27/02/2023 Human medicines European public assessment report (EPAR): NovoSeven, eptacog alfa (activated), Hemophilia B; Thrombasthenia; Factor VII Deficiency; Hemophilia A, 23/02/1996, 38, Authorised
27/02/2023 News and press releases: EMA pilots scientific advice for certain high-risk medical devices
27/02/2023 Orphan designation: Ribitol for the: Treatment of limb-girdle muscular dystrophy, 19/10/2020, Positive
27/02/2023 Report: Medicinal products for human use: monthly figures - January 2023
24/02/2023 Regulatory and scientific virtual conference on RNA-based medicines , Online, 09:00 - 16:30 Amsterdam time (CET), from 02/02/2023 to 02/02/2023
24/02/2023 Other: PRAC meetings in 2022, 2023 and 2024
24/02/2023 Human medicines European public assessment report (EPAR): Pelmeg, pegfilgrastim, Neutropenia, 20/11/2018, Additional monitoring, Biosimilar, 7, Authorised
24/02/2023 Human medicines European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma), pegfilgrastim, Neutropenia, 19/12/2019, Additional monitoring, Biosimilar, 7, Authorised
24/02/2023 Human medicines European public assessment report (EPAR): Nyxoid, Naloxone hydrochloride dihydrate, Opioid-Related Disorders, 09/11/2017, 8, Authorised
24/02/2023 Plasmid DNA vaccines for veterinary use – Scientific guideline
24/02/2023 Scientific guideline: Guideline on plasmid DNA vaccines for veterinary use
24/02/2023 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20 - 23 February 2023
24/02/2023 Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against SERPINA1 mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues for the: Treatment of congenital alpha-1 antitrypsin deficiency, 16/12/2019, Positive
24/02/2023 Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues for the: Treatment of primary hyperoxaluria, 31/07/2018, Positive
24/02/2023 Orphan designation: Patidegib for the: Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome), 21/03/2018, Positive
24/02/2023 Orphan designation: Recombinant human ADAMTS-13 for the: Treatment of thrombotic thrombocytopenic purpura, 03/12/2008, Positive
24/02/2023 Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 10:00 - 12:00 Amsterdam time (CET), from 26/01/2023 to 26/01/2023
24/02/2023 Information session on the pilot for expert panels’ scientific advice to manufacturers of high-risk medical devices , Online, 14:00 - 15:30 Amsterdam time (CET), from 25/01/2023 to 25/01/2023
24/02/2023 Human medicines European public assessment report (EPAR): Aloxi, palonosetron hydrochloride, Vomiting; Cancer, 22/03/2005, 22, Authorised
24/02/2023 Human medicines European public assessment report (EPAR): Ulunar Breezhaler, Glycopyrronium bromide, indacaterol maleate, Pulmonary Disease, Chronic Obstructive, 23/04/2014, 14, Authorised
24/02/2023 Human medicines European public assessment report (EPAR): Fulvestrant Mylan, fulvestrant, Breast Neoplasms, 08/01/2018, Generic, 5, Authorised
24/02/2023 Human medicines European public assessment report (EPAR): Vizarsin, sildenafil, Erectile Dysfunction, 21/09/2009, Generic, 19, Authorised
23/02/2023 Availability of veterinary medicines
23/02/2023 Clinical trials in human medicines
23/02/2023 Agenda: Agenda of the CHMP meeting 20-23 February 2023
23/02/2023 Human medicines European public assessment report (EPAR): Rasilez, aliskiren, Hypertension, 22/08/2007, 27, Authorised
23/02/2023 Other: Mandate, objectives and rules of procedure for the Oncology European Specialised Expert Communities (ESEC)
23/02/2023 Other: Multilingualism on the EMA website and in external communications
23/02/2023 Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 09:30 - 12:00 Amsterdam time (CET), from 23/02/2023 to 23/02/2023
23/02/2023 Human medicines European public assessment report (EPAR): Rasagiline Mylan, rasagiline tartrate, Parkinson Disease, 04/04/2016, Generic, 7, Authorised
23/02/2023 Withdrawn application: Ilaris, canakinumab, Date of withdrawal: 26/10/2022, Post-authorisation
23/02/2023 Human medicines European public assessment report (EPAR): Zonegran, zonisamide, Epilepsies, Partial, 10/03/2005, 36, Authorised
23/02/2023 Human medicines European public assessment report (EPAR): Stalevo, levodopa, carbidopa, entacapone, Parkinson Disease, 17/10/2003, 29, Authorised
22/02/2023 Human variations electronic application form (eAF) Q&A clinics – session 6 , Online, 15:30 - 16:00 Amsterdam time (CET), from 17/01/2023 to 17/01/2023
22/02/2023 Human variations electronic application forms Q&A clinics – session 5 , Online, 14:30 - 15:00 Amsterdam time (CET), from 19/12/2022 to 19/12/2022
22/02/2023 Human variations electronic application forms public training , Online, 10:00 - 11:30 Amsterdam time (CET), from 15/12/2022 to 15/12/2022
22/02/2023 Human medicines European public assessment report (EPAR): Inovelon, Rufinamide, Epilepsy, 16/01/2007, 23, Authorised
22/02/2023 Human medicines European public assessment report (EPAR): Azacitidine Mylan, azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute, 27/03/2020, Generic, 5, Authorised
22/02/2023 Human variations electronic application forms Q&A clinics – session 4 , Online, 14:30 - 15:00 Amsterdam time (CET), from 14/12/2022 to 14/12/2022
22/02/2023 Human medicines European public assessment report (EPAR): Zalasta, olanzapine, Schizophrenia; Bipolar Disorder, 27/09/2007, Generic, 20, Authorised
22/02/2023 Human medicines European public assessment report (EPAR): Pemetrexed Krka, pemetrexed disodium, Carcinoma, Non-Small-Cell Lung; Mesothelioma, 22/05/2018, Generic, 6, Authorised
22/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Tildacerfont, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0036/2022
22/02/2023 Other: European Medicines Agency policy on changes in scope of paediatric-investigation-plan decisions
22/02/2023 Herbal medicinal product: Hyperici herba, Hyperici herba, F: Assessment finalised
22/02/2023 Human medicines European public assessment report (EPAR): Dimethyl fumarate Accord, dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, 15/02/2023, Generic, Authorised
22/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Pyridine-3-carboxamide derivative (K-161), W: decision granting a waiver in all age groups for all conditions or indications, P/0467/2021
22/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Depemokimab, W: decision granting a waiver in all age groups for all conditions or indications, P/0417/2021
22/02/2023 Human medicines European public assessment report (EPAR): Lamzede, velmanase alfa, alpha-Mannosidosis, 23/03/2018, Orphan, Additional monitoring, Exceptional circumstances, 6, Authorised
22/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): B cell maturation antigen antibody-drug conjugate comprised of an immunoglobulin G1 humanized antibody conjugated covalently to the dibenzocyclooctyne noncleavable linker maytansinoid warhead (BMS-986352), W: decision granting a waiver in all age groups for all conditions or indications, P/0420/2021
22/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Rusfertide, W: decision granting a waiver in all age groups for all conditions or indications, P/0422/2021
22/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Alnuctamab, W: decision granting a waiver in all age groups for all conditions or indications, P/0421/2021
22/02/2023 Human medicines European public assessment report (EPAR): Nimvastid, rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease, 11/05/2009, Generic, 10, Authorised
22/02/2023 Human medicines European public assessment report (EPAR): Tolura, Telmisartan, Hypertension, 04/06/2010, Generic, 11, Authorised
22/02/2023 Human medicines European public assessment report (EPAR): Yargesa, miglustat, Gaucher Disease, 22/03/2017, Generic, 5, Authorised
22/02/2023 Periodic safety update single assessment: Piracetam : List of nationally authorised medicinal products - PSUSA/00002429/202204
22/02/2023 Human medicines European public assessment report (EPAR): Taltz, ixekizumab, Psoriasis, 25/04/2016, 17, Authorised
22/02/2023 Human medicines European public assessment report (EPAR): Namuscla, Mexiletine hydrochloride, Myotonic Disorders, 18/12/2018, Orphan, 5, Authorised
21/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Batiraxcept, W: decision granting a waiver in all age groups for all conditions or indications, P/0431/2021
21/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Anti-CD123 IgG1 humanised monoclonal antibody conjugated to N1-(2-(2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)ethyl)-N6-((S)-1-(((S)-1-((3-((((S)-8-methoxy-6-oxo-11,12,12a,13-tetrahydro-6H-benzo[5,6][1,4]diazepino[1,2-a]indol-9-yl)oxy)methyl)-5-((((S)-8-methoxy-6-oxo-12a,13-dihydro-6Hbenzo[5,6][1,4]diazepino[1,2-a]indol-9-yl)oxy)methyl)phenyl)amino)-1-oxopropan-2-yl)amino)-1-oxopropan-2-yl)adipamide, W: decision granting a waiver in all age groups for all conditions or indications, P/0425/2021
21/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): amlodipine,zofenopril, W: decision granting a waiver in all age groups for all conditions or indications, P/0436/2021
21/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): lutetium (177Lu) chloride, W: decision granting a waiver in all age groups for all conditions or indications, P/0433/2021
21/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Izaflortaucipir (18F), W: decision granting a waiver in all age groups for all conditions or indications, P/0432/2021
21/02/2023 Clinical Trials Information System (CTIS) Webinar - 9 months on and going forward - November 2022 , Online, 13:30 - 17:30 Amsterdam time (CET), from 16/11/2022 to 16/11/2022
21/02/2023 Periodic safety update single assessment: Glimepiride : List of nationally authorised medicinal products - PSUSA/00001534/202206
21/02/2023 Nitrosamines Safety Operational Expert Group
21/02/2023 Other: Release notes - production release version 1.6.216 January 2023 - Veterinary Medicinal Products Regulation: Union Product Database
21/02/2023 Other: CTIS Training materials - Latest updates
21/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica, Ibrutinib, PM: decision on the application for modification of an agreed PIP, P/0337/2021
21/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Repatha, Evolocumab, PM: decision on the application for modification of an agreed PIP, P/0104/2018
21/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H5N1, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0144/2022
21/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Delandistrogene moxeparvovec, PM: decision on the application for modification of an agreed PIP, P/0230/2022
21/02/2023 Herbal medicinal product: Vaccinii macrocarpi fructus, Vaccinii macrocarpi fructus, F: Assessment finalised
21/02/2023 Direct healthcare professional communication (DHPC): Xalkori (crizotinib): Vision disorders, including risk of severe visual loss, need for monitoring in paediatric patients, Active substance: crizotinib, DHPC type: Adverse event, Last updated: 21/02/2023
21/02/2023 Direct healthcare professional communication (DHPC): Spikevax bivalent Original/Omicron BA.1, pre-filled syringe - Labelling deviation , Active substance: CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), DHPC type: Adverse event, Last updated: 21/02/2023
21/02/2023 Supply shortage: Fasturtec (rasburicase) supply shortage
20/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Dexamethasone (sodium phosphate),ofloxacin, W: decision granting a waiver in all age groups for all conditions or indications, P/0448/2021
20/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Senaparib, W: decision granting a waiver in all age groups for all conditions or indications, P/0445/2021
20/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe,Rosuvastatin, W: decision granting a waiver in all age groups for all conditions or indications, P/0462/2021
20/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Propan-2-yl (2S)-2-{[(S)-({(2R,3R,4R,5R)-5-[2-amino-6-(methylamino)-9H-purin-9-yl]-4-fluoro-3- hydroxy-4-methyloxolan-2-yl}methoxy)(phenoxy)phosphoryl]amino}propanoate; sulfuric acid (2:1) (AT-527 / RO7496998), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0463/2021
20/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Terbinafine hydrochloride, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0450/2021
20/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Humanized monoclonal antibody of IgG1 sub-type targeting the human SEMA3A polypeptide, W: decision granting a waiver in all age groups for all conditions or indications, P/0437/2021
20/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): 2-[(4-{6-[(4-cyano-2-fluorobenzyl)oxy]pyridin-2-yl}piperidin-1-yl)methyl]-1-[(2S)-oxetan-2-ylmethyl]-1H-benzimidazole-6-carboxylic acid tris(hydroxymethyl)aminomethane salt (1:1) (PF-06882961), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0452/2021
20/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Islatravir, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0407/2021
20/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): crisantaspase, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0453/2021
20/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Anti-C1s Humanized IgG4 Monoclonal Antibody, W: decision granting a waiver in all age groups for all conditions or indications, P/0434/2021
20/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Thienopyrimidine Derivative, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0459/2021
20/02/2023 Human medicines European public assessment report (EPAR): Cuprior, Trientine tetrahydrochloride, Hepatolenticular Degeneration, 05/09/2017, 6, Authorised
20/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe,Rosuvastatin, W: decision granting a waiver in all age groups for all conditions or indications, P/0469/2021
20/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Perflubutane, RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s), P/0435/2021
20/02/2023 Human medicines European public assessment report (EPAR): Sapropterin Dipharma, Sapropterin dihydrochloride, Phenylketonurias, 16/02/2022, Generic, 3, Authorised
20/02/2023 Human medicines European public assessment report (EPAR): Vaxelis, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3, hepatitis B surface antigen produced in yeast cells, poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein., Meningitis, Haemophilus; Poliomyelitis; Tetanus; Diphtheria; Whooping Cough; Hepatitis B, 15/02/2016, 14, Authorised
20/02/2023 Human medicines European public assessment report (EPAR): Odefsey, emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide, HIV Infections, 21/06/2016, 20, Authorised
20/02/2023 Human medicines European public assessment report (EPAR): Spherox, spheroids of human autologous matrix-associated chondrocytes, Cartilage Diseases, 10/07/2017, 8, Authorised
20/02/2023 Human medicines European public assessment report (EPAR): Sixmo, Buprenorphine hydrochloride, Opioid-Related Disorders, 19/06/2019, Additional monitoring, 4, Authorised
20/02/2023 Human medicines European public assessment report (EPAR): Xagrid, Anagrelide, Thrombocythemia, Essential, 15/11/2004, 40, Authorised
20/02/2023 Herbal medicinal product: Agrimoniae herba, Agrimoniae herba, F: Assessment finalised
20/02/2023 Other: Considerations for research / project teams seeking competent authority participation in externally funded regulatory science and public health research projects related to medicinal products
20/02/2023 Human medicines European public assessment report (EPAR): Kerendia, Finerenone, Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2, 16/02/2022, Additional monitoring, 1, Authorised
20/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): guanfacine hydrochloride, PM: decision on the application for modification of an agreed PIP, P/0265/2013
17/02/2023 Frequently asked questions
17/02/2023 Submission deadlines for orphan designations
17/02/2023 Direct healthcare professional communication (DHPC): Terlipressin: Serious or fatal respiratory failure and sepsis/septic shock in patients with type 1 hepatorenal syndrome (type 1 HRS), Active substance: terlipressin, DHPC type: Referral - Article 31, Last updated: 17/02/2023
17/02/2023 Minutes: Minutes of the PRAC meeting 26-29 September 2022
17/02/2023 Summary of opinion: Suvaxyn PRRS MLV, porcine respiratory and reproductive syndrome virus, live, 15/02/2023, Positive
17/02/2023 Summary of opinion: Zeleris, florfenicol, meloxicam, 15/02/2023, Positive
17/02/2023 Summary of opinion: Lotilaner Elanco, lotilaner, 15/02/2023, Positive
17/02/2023 Summary of opinion: Prolevare, oclacitinib maleate, 15/02/2023, Positive
17/02/2023 Summary of opinion: Coxevac, inactivated Coxiella burnetii vaccine, 15/02/2023, Positive
17/02/2023 Summary of opinion: Innovax-ILT-IBD, turkey herpes virus, expressing infectious bursal disease virus and avian infectious laryngotracheitis virus, strain HVT/IBD/ILT, live, 15/02/2023, Positive
17/02/2023 Summary of opinion: Eurican L4, inactivated immunological veterinary medicinal product containing Leptospira interrogans, serogroup Canicola, serovar Canicola, strain 16070, L. interrogans, serogroup icterohaemorrhagiae, serovar icterohaemorrhagiae, strain 16069, L. interrogans, serogroup Grippotyphosa, serovar Grippotyphosa, strain Grippo Mal 1540, L. interrogans, serogroup Australis, serovar Bratislava, strain, 15/02/2023, Positive
17/02/2023 Summary of opinion: Bovilis Nasalgen-C, bovine coronavirus, strain CA25, live, 15/02/2023, Positive
17/02/2023 Summary of opinion: Bravecto Plus, fluralaner, moxidectin, 15/02/2023, Positive
17/02/2023 Direct healthcare professional communication (DHPC): ZOLGENSMA (onasemnogene abeparvovec) - Fatal cases of acute liver failure, Active substance: Onasemnogene abeparvovec, DHPC type: Adverse event, Last updated: 17/02/2023
17/02/2023 Template or form: Template - Innovation Task Force briefing document
17/02/2023 Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Veterinary - Scientific guideline
17/02/2023 Chemistry of active substances for veterinary medicinal products - Scientific guideline
17/02/2023 Regulatory and procedural guideline: Rules of procedure on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)
17/02/2023 Human medicines European public assessment report (EPAR): Descovy, emtricitabine, tenofovir alafenamide, HIV Infections, 21/04/2016, 20, Authorised
17/02/2023 Template or form: Innovation Task Force (ITF) briefing meeting request form
17/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): surufatinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0142/2021
17/02/2023 PIP - Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision: Surufatinib - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision
17/02/2023 Direct healthcare professional communication (DHPC): Neofordex 40 mg (dexamethasone): removal of the score-line and the associated 20 mg posology, Active substance: dexamethasone, DHPC type: Change in dosing recommendation, Last updated: 17/02/2023
17/02/2023 Direct healthcare professional communication (DHPC): Supply shortage of Fasturtec (rasburicase) 7.5 mg/5 ml powder and solvent for concentrate for solution for infusion (EU/1/00/170/002), Active substance: rasburicase, DHPC type: Medicine shortage, Last updated: 17/02/2023
16/02/2023 Adjuvants in vaccines for human use - Scientific guideline
16/02/2023 Periodic safety update single assessment: Flecainide - List of nationally authorised medicinal products - PSUSA/00001396/202206
16/02/2023 Orphan designation: 2-hydroxy-N,N,N-trimethylethan-1-aminium (Z)-4-(5-((3-benzyl-4-oxo-2-thioxothiazolidin-5-ylidene)methyl)furan-2-yl)benzoate for the: Treatment of pancreatic cancer, 24/03/2020, Withdrawn
16/02/2023 ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Scientific guideline
16/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Edarbi, Azilsartan medoxomil, PM: decision on the application for modification of an agreed PIP, P/0530/2021
16/02/2023 Human medicines European public assessment report (EPAR): Roclanda, Latanoprost, Netarsudil mesilate, Glaucoma, Open-Angle; Ocular Hypertension, 07/01/2021, Additional monitoring, 4, Authorised
16/02/2023 Herbal medicinal product: Pruni cerasi stipites, Pruni cerasi stipites, C: ongoing call for scientific data
16/02/2023 Herbal medicinal product: Cannabis flos, Cannabis flos, C: ongoing call for scientific data
16/02/2023 Herbal medicinal product: Species pectoralis, Combination: Species pectoralis, C: ongoing call for scientific data
16/02/2023 Herbal medicinal product: Cnici benedicti herba, Cnici benedicti herba, D: Draft under discussion
16/02/2023 Human medicines European public assessment report (EPAR): LysaKare, L-arginine hydrochloride, L-lysine hydrochloride, Radiation Injuries, 25/07/2019, 3, Authorised
16/02/2023 Human medicines European public assessment report (EPAR): Apexxnar, Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 8, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 10A, Pneumococcal polysaccharide serotype 11A, Pneumococcal polysaccharide serotype 12F, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 15b, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 22F, Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 33F, Pneumococcal Infections, 14/02/2022, Additional monitoring, 4, Authorised
16/02/2023 Human medicines European public assessment report (EPAR): Intuniv, guanfacine hydrochloride, Attention Deficit Disorder with Hyperactivity, 17/09/2015, Additional monitoring, 12, Authorised
16/02/2023 Human medicines European public assessment report (EPAR): Zoely, Nomegestrol acetate, estradiol, Contraception, 26/07/2011, 23, Authorised
16/02/2023 Human medicines European public assessment report (EPAR): Thiotepa Riemser, thiotepa, Hematopoietic Stem Cell Transplantation; Neoplasms, 26/03/2021, Generic, 3, Authorised
16/02/2023 News and press releases: Human medicines: highlights of 2022
16/02/2023 News and press releases: Veterinary medicines: highlights of 2022
16/02/2023 Report: Veterinary Medicines Highlights 2022
16/02/2023 Template or form: Day 80 assessment report - Overview and D120 LOQ template with guidance - Rev. 02.23
15/02/2023 Clinical Trials Information System (CTIS) bitesize talk: Annual safety report (ASR) , Online, 16:30 - 18:00 Amsterdam time (CET) (Updated), from 15/12/2022 to 15/12/2022
15/02/2023 Human medicines European public assessment report (EPAR): Strensiq, asfotase alfa, Hypophosphatasia, 28/08/2015, Orphan, Additional monitoring, Exceptional circumstances, 16, Authorised
15/02/2023 Other: Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP)
15/02/2023 Work programme: Work plan for the Biologics Working Party (BWP) for 2023
15/02/2023 Other: Questions and answers by the Query Management Working Group on CTIS and the CTR
15/02/2023 Herbal - Call for data: Call for scientific data for the use in HMPC assessment work on Pruni cerasi stipites
15/02/2023 Herbal - Call for data: Call for scientific data for use in HMPC assessment work on herbal tea combinations traditionally used in the therapeutic area ‘cough and cold’
15/02/2023 Herbal medicinal product: Tiliae flos, Tiliae flos, F: Assessment finalised
15/02/2023 Advanced therapy medicinal products: Overview
15/02/2023 Orphan review: Recommendation for maintenance of orphan designation at the time of marketing authorisation: NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) for the treatment of partial deep dermal and full-thickness...
15/02/2023 Orphan designation: Omigapil maleate for the: Treatment of congenital muscular dystrophy with merosin (laminin alpha 2) deficiency, 08/05/2008, Positive
15/02/2023 Orphan designation: proteolytic enzymes enriched in bromelain for the: Treatment of partial deep dermal and full-thickness burns, 30/07/2002, Expired
15/02/2023 Herbal medicinal products: questions and answers
15/02/2023 Regulatory and procedural guideline: Questions & Answers regarding Cannabis-derived medicinal products and the scope of EU herbal monographs for herbal medicinal products within the EU medicines legislation
15/02/2023 Herbal - Call for data: Call for scientific data for use in HMPC assessment work on Cannabis sativa L., flos (Cannabis sativa flowering tops)
15/02/2023 Direct healthcare professional communication (DHPC): CYSTAGON (mercaptamine bitartrate), Active substance: mercaptamine bitartrate, DHPC type: Quality defect, Last updated: 15/02/2023
15/02/2023 Supply shortage: Cetrotide (cetrorelix acetate) supply shortage
15/02/2023 Agenda: Agenda of the CAT meeting 15-17 February 2023
14/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Live-attenuated La Reunion strain of chikungunya virus (VLA1553), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0457/2021
14/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Respiratory Syncytial Virus (RSV) PreF3 recombinant Fusion protein/AS01, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0456/2021
14/02/2023 Need for a paediatric addendum of the guideline on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease - Scientific guideline
14/02/2023 Periodic safety update single assessment: Itopride : List of nationally authorised medicinal products - PSUSA/00010606/202206
14/02/2023 Report: Applications for new human medicines under evaluation by the CHMP: February 2023
14/02/2023 Herbal medicinal product: Paulliniae semen, Paulliniae semen, F: Assessment finalised
14/02/2023 Periodic safety update single assessment: Phentermine/ topiramate - List of nationally authorised medicinal products - PSUSA/00010956/202207
14/02/2023 Periodic safety update single assessment: Allergen for therapy: betula verrucosa (sublingual use) : List of nationally authorised medicinal products - PSUSA/00010815/202207
14/02/2023 Periodic safety update single assessment: Ibuprofen / pseudoephedrine - List of nationally authorised medicinal products - PSUSA/00001711/202207
14/02/2023 Human medicines European public assessment report (EPAR): Venclyxto, Venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell, 04/12/2016, Additional monitoring, 15, Authorised
14/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-methoxy, ether with N-[[[2-[[6-[[1-[3-[[3-(2,3-dihydroxypropoxy)propyl]amino]-3-oxopropyl]-2,5-dioxo-3-pyrrolidinyl]thio]hexyl]amino]ethyl]amino]carbonyl]-2-methylalanyl-teriparatide (2:1) (TransCon PTH), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0021/2022
14/02/2023 Human medicines European public assessment report (EPAR): Tybost, cobicistat, HIV Infections, 19/09/2013, 15, Authorised
14/02/2023 Direct healthcare professional communication (DHPC): ADAKVEO (crizanlizumab): Phase III study (CSEG101A2301) shows no superiority of crizanlizumab over placebo, Active substance: Crizanlizumab, DHPC type: Referral - Article 20 procedure, Last updated: 14/02/2023
14/02/2023 Maximum residue limits (MRL)
13/02/2023 Agenda: Agenda of the CVMP meeting 14-16 February 2023
13/02/2023 Orphan designation: Treprostinil sodium for the: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive
13/02/2023 Orphan designation: Treprostinil diethanolamine for the: Treatment of systemic sclerosis, 15/05/2009, Positive
13/02/2023 Work programme: Consolidated 3-year work plan for the Infectious Disease Working Party (IDWP)
13/02/2023 Orphan designation: Treprostinil sodium for the: Treatment of idiopathic pulmonary fibrosis, 16/03/2022, Positive
13/02/2023 Orphan designation: Ralinepag for the: Treatment of pulmonary arterial hypertension, 11/01/2019, Positive
13/02/2023 Template or form: European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) web based data collection form
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ozempic, semaglutide, PM: decision on the application for modification of an agreed PIP, P/0461/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Xevudy, Sotrovimab, PM: decision on the application for modification of an agreed PIP, P/0468/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human A disintegrin and metalloprotease with thrombospind type-1 motifs 13, PM: decision on the application for modification of an agreed PIP, P/0414/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Evrysdi, Risdiplam (RO7034067), PM: decision on the application for modification of an agreed PIP, P/0470/2021
13/02/2023 Other: Rules for reimbursement of expenses for delegates attending meetings with effect from 16 June 2022
13/02/2023 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/0443/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Gavreto, pralsetinib, W: decision granting a waiver in all age groups for all conditions or indications, P/0428/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Fluocinolone acetonide, PM: decision on the application for modification of an agreed PIP, P/0442/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): imatinib, PM: decision on the application for modification of an agreed PIP, P/0424/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): temozolomide, PM: decision on the application for modification of an agreed PIP, P/0418/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0413/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Pritelivir (mesylate monohydrate), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0458/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Anti-neonatal Fc receptor human monoclonal antibody, W: decision granting a waiver in all age groups for all conditions or indications, P/0419/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib, PM: decision on the application for modification of an agreed PIP, P/0439/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib, PM: decision on the application for modification of an agreed PIP, P/0440/2021
13/02/2023 Human medicines European public assessment report (EPAR): Nulojix, belatacept, Graft Rejection; Kidney Transplantation, 17/06/2011, 20, Authorised
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ganaxolone, PM: decision on the application for modification of an agreed PIP, P/0404/2021
13/02/2023 Human medicines European public assessment report (EPAR): Lutathera, lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors, 26/09/2017, Orphan, 9, Authorised
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Kaftrio, elexacaftor,tezacaftor,ivacaftor, PM: decision on the application for modification of an agreed PIP, P/0265/2022
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Doxylamine (succinate),pyridoxine (hydrochloride), W: decision granting a waiver in all age groups for all conditions or indications, P/0410/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Alunbrig, brigatinib, PM: decision on the application for modification of an agreed PIP, P/0405/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): drospirenone, W: decision granting a waiver in all age groups for all conditions or indications, P/0451/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Byfavo, Remimazolam (as besilate), PM: decision on the application for modification of an agreed PIP, P/0427/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human glutamic acid decarboxylase (rhGAD65), PM: decision on the application for modification of an agreed PIP, P/0441/2021
13/02/2023 EMA/HMA Big Data Stakeholder Forum 2022 , Online, 9:00 - 17:55 Amsterdam time (CET), from 01/12/2022 to 01/12/2022
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Calquence, Acalabrutinib, PM: decision on the application for modification of an agreed PIP, P/0408/2021
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Oxalobacter formigenes strain HC-1, PM: decision on the application for modification of an agreed PIP, P/0447/2021
13/02/2023 Human medicines European public assessment report (EPAR): Azacitidine betapharm, azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute, 24/03/2020, Generic, 5, Authorised
13/02/2023 Human medicines European public assessment report (EPAR): Tracleer, bosentan (as monohydrate), Scleroderma, Systemic; Hypertension, Pulmonary, 14/05/2002, 42, Authorised
13/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe,Rosuvastatin, W: decision granting a waiver in all age groups for all conditions or indications, P/0411/2021
13/02/2023 Human medicines European public assessment report (EPAR): Stayveer, bosentan (as monohydrate), Hypertension, Pulmonary; Scleroderma, Systemic, 24/06/2013, 15, Authorised
10/02/2023 Periodic safety update single assessment: Germanium (68Ge) chloride / gallium (68Ga) chloride : List of nationally authorised medicinal products - PSUSA/00010364/202203
10/02/2023 Periodic safety update single assessment: Human coagulation factor XIII : List of nationally authorised medicinal products - PSUSA/00001622/202206
10/02/2023 Joint EMA-FDA workshop: Efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants , Online, 13:00 - 17:00 Amsterdam time (CET), from 15/12/2022 to 15/12/2022
10/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): Ozempic, semaglutide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0464/2021
10/02/2023 Opinion/decision on a Paediatric investigation plan (PIP): RoActemra, tocilizumab, RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s), P/0466/2021
10/02/2023 Periodic safety update single assessment: Nitrous oxide, nitrous oxide / oxygen - List of nationally authorised medicinal products - PSUSA/00010572/202206
10/02/2023 Withdrawn application: Aliqopa, copanlisib, Date of withdrawal: 20/12/2021, Initial authorisation
10/02/2023 Periodic safety update single assessment: Sulfamethizole - List of nationally authorised medicinal products - PSUSA/00010561/202206
10/02/2023 Periodic safety update single assessment: Apis mellifera (801) (with or without adjuvant), Apis mellifera venom - List of nationally authorised medicinal products - PSUSA/00010722/202207
10/02/2023 Periodic safety update single assessment: Methylaminolevulinate : List of nationally authorised medicinal products - PSUSA/00002019/202206
10/02/2023 Periodic safety update single assessment: Theophylline - List of nationally authorised medicinal products - PSUSA/00002921/202206
10/02/2023 Other: Timetable: Type II variation and worksharing application monthly assessment
10/02/2023 News and press releases: PRAC starts safety review of pseudoephedrine-containing medicines
10/02/2023 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 - 9 February 2023
10/02/2023 Periodic safety update single assessment: Allergen for diagnostic and or therapy Vespula SPP. (802) (with or without adjuvant), Wasp venom - nationally authorised product only) - List of nationally authorised medicinal products - PSUSA/00010721/202207
10/02/2023 Periodic safety update single assessment: Pentamidine : List of nationally authorised medicinal products - PSUSA/00002338/202206
10/02/2023 Periodic safety update single assessment: Ganciclovir : List of nationally authorised medicinal products - PSUSA/00001516/202206
10/02/2023 Periodic safety update single assessment: Cilastatin / Imipenem : List of nationally authorised medicinal products - PSUSA/00000748/202206
10/02/2023 Periodic safety update single assessment: Amorolfine : List of nationally authorised medicinal products - PSUSA/00000185/202206
10/02/2023 Regulatory and procedural guideline: Validation checklist for Type II quality variations
10/02/2023 EMA regular press briefing on public health emergencies , Online, 14:00 - 14:30 Amsterdam time (CET), from 15/02/2023 to 15/02/2023
09/02/2023 Agenda: Agenda - Regulatory and scientific virtual conference on RNA-based medicines
09/02/2023 Periodic safety update single assessment: Acamprosate : List of nationally authorised medicinal products - PSUSA/00000016/202207
09/02/2023 Other: Note on European Medicines Agency’s involvement in HORIZON-HLTH-2023-TOOL-05-09: Developing a Data Quality and Utility Label for the European Health Data Space
09/02/2023 Human medicines European public assessment report (EPAR): Hemangiol, propranolol hydrochloride, Hemangioma, 23/04/2014, 6, Authorised
09/02/2023 Public health threats
09/02/2023 Human medicines European public assessment report (EPAR): Harvoni, ledipasvir, Sofosbuvir, Hepatitis C, Chronic, 17/11/2014, Accelerated assessment, 27, Authorised
09/02/2023 Human medicines European public assessment report (EPAR): Sovaldi, Sofosbuvir, Hepatitis C, Chronic, 16/01/2014, Accelerated assessment, 27, Authorised
09/02/2023 Substance and product data management services
09/02/2023 Human medicines European public assessment report (EPAR): Pregabalin Zentiva, pregabalin, Anxiety Disorders; Epilepsy, 17/07/2015, Generic, 15, Authorised