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European public assessment report (EPAR): Temozolomide Hexal, temozolomide, Glioma; Glioblastoma, 15/03/2010, , 17, Withdrawn |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, , , 7, Authorised |
24/02/2023 |
Human medicines European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma), pegfilgrastim, Neutropenia, 19/12/2019, , , 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, , 5, Authorised |
24/02/2023 |
Human medicines European public assessment report (EPAR): Vizarsin, sildenafil, Erectile Dysfunction, 21/09/2009, , 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, , 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, , 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, , 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, , 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, , 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, , , , 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, , 10, Authorised |
22/02/2023 |
Human medicines European public assessment report (EPAR): Tolura, Telmisartan, Hypertension, 04/06/2010, , 11, Authorised |
22/02/2023 |
Human medicines European public assessment report (EPAR): Yargesa, miglustat, Gaucher Disease, 22/03/2017, , 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, , 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, , 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, , 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, , 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, , 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, , 4, Authorised |
16/02/2023 |
Human medicines European public assessment report (EPAR): Intuniv, guanfacine hydrochloride, Attention Deficit Disorder with Hyperactivity, 17/09/2015, , 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, , 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, , , , 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, , 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, , 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, , 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, , 27, Authorised |
09/02/2023 |
Human medicines European public assessment report (EPAR): Sovaldi, Sofosbuvir, Hepatitis C, Chronic, 16/01/2014, , 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, , 15, Authorised |