What's new

Date	Content
28/02/2023	Leaflet: Leaflet - Orphan medicines in the EU (updated)
28/02/2023	Human medicines European public assessment report (EPAR): Cibinqo, Abrocitinib, Dermatitis, Atopic, 09/12/2021, , , 3, Authorised (updated)
28/02/2023	Human medicines European public assessment report (EPAR): Lenvima, lenvatinib mesilate, Thyroid Neoplasms, 28/05/2015, , , 17, Authorised (updated)
28/02/2023	Human medicines European public assessment report (EPAR): Onpattro, patisiran sodium, Amyloidosis, Familial, 27/08/2018, , , , 10, Authorised (updated)
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 (updated)
27/02/2023	Human medicines European public assessment report (EPAR): Simulect, basiliximab, Graft Rejection; Kidney Transplantation, 09/10/1998, 27, Authorised (updated)
27/02/2023	Human medicines European public assessment report (EPAR): Tafinlar, dabrafenib mesilate, Melanoma, 26/08/2013, 28, Authorised (updated)
27/02/2023	Human medicines European public assessment report (EPAR): Temozolomide Hexal, temozolomide, Glioma; Glioblastoma, 15/03/2010, , 17, Withdrawn (updated)
27/02/2023	Human medicines European public assessment report (EPAR): Invokana, canagliflozin, Diabetes Mellitus, Type 2, 15/11/2013, 21, Authorised (updated)
27/02/2023	Regulatory and procedural guideline: European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 (updated)
27/02/2023	Human medicines European public assessment report (EPAR): Vokanamet, canagliflozin, metformin hydrochloride, Diabetes Mellitus, Type 2, 23/04/2014, 20, Authorised (updated)
27/02/2023	Human medicines European public assessment report (EPAR): Mekinist, trametinib, Melanoma, 30/06/2014, 29, Authorised (updated)
27/02/2023	Human medicines European public assessment report (EPAR): Ferriprox, Deferiprone, beta-Thalassemia; Iron Overload, 25/08/1999, 32, Authorised (updated)
27/02/2023	Human medicines European public assessment report (EPAR): Ikervis, ciclosporin, Corneal Diseases, 19/03/2015, 10, Authorised (updated)
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 (updated)
27/02/2023	Human medicines European public assessment report (EPAR): Lokelma, sodium zirconium cyclosilicate, Hyperkalemia, 22/03/2018, 8, Authorised (updated)
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 (updated)
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): Veltassa, patiromer sorbitex calcium, Hyperkalemia, 19/07/2017, , 7, Authorised
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	Withdrawn application: Buvidal, buprenorphine, Date of withdrawal: 13/02/2023, Post-authorisation
24/02/2023	Summary of opinion: Tidhesco, ivosidenib, 23/02/2023, Positive
24/02/2023	Summary of opinion: Tibsovo, ivosidenib, 23/02/2023, Positive
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	Summary of opinion: TachoSil, human fibrinogen, human thrombin, 23/02/2023, Positive
24/02/2023	Summary of opinion: Elfabrio, pegunigalsidase alfa, 23/02/2023, Positive
24/02/2023	Article 5(3) opinions
24/02/2023	Summary of opinion: Bekemv, eculizumab, 23/02/2023, Positive
24/02/2023	Summary of opinion: Opzelura, ruxolitinib, 23/02/2023, Positive
24/02/2023	Summary of opinion: Esbriet, pirfenidone, 23/02/2023, Positive
24/02/2023	Summary of opinion: Rinvoq, upadacitinib, 23/02/2023, Positive
24/02/2023	Summary of opinion: Libtayo, cemiplimab, 23/02/2023, Positive
24/02/2023	Summary of opinion: Vafseo, vadadustat, 23/02/2023, Positive
24/02/2023	Summary of opinion: Akeega, niraparib, abiraterone acetate, 23/02/2023, Positive
24/02/2023	Summary of opinion: Hyftor, sirolimus, 23/02/2023, Positive
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 (CEST), 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): Fycompa, perampanel, Epilepsies, Partial, 23/07/2012, 31, Authorised
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): Dovprela (previously Pretomanid FGK), Pretomanid, Tuberculosis, Multidrug-Resistant, 31/07/2020, , , , 7, 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): Telmisartan Actavis, telmisartan, Hypertension, 29/09/2010, , 11, 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	Availability of medicines
23/02/2023	National registers of shortages
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): Mounjaro, Tirzepatide, Diabetes Mellitus, Type 2, 15/09/2022, 2, Authorised
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	Human medicines European public assessment report (EPAR): Evenity, Romosozumab, Osteoporosis, 09/12/2019, , 3, Authorised
23/02/2023	Management Board meeting: 14-15 December 2022 , European Medicines Agency, Amsterdam, the Netherlands, from 14/12/2022 to 15/12/2022
23/02/2023	Human medicines European public assessment report (EPAR): Qinlock, ripretinib, Gastrointestinal Stromal Tumors, 18/11/2021, , , 2, Authorised
23/02/2023	Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 09:30 - 12:00 Amsterdam time (CEST), from 23/02/2023 to 23/02/2023
23/02/2023	Human medicines European public assessment report (EPAR): Xarelto, rivaroxaban, Arthroplasty, Replacement; Venous Thromboembolism, 30/09/2008, 39, Authorised
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): Vizamyl, flutemetamol (18F), Radionuclide Imaging; Alzheimer Disease, 22/08/2014, 15, Authorised
23/02/2023	Human medicines European public assessment report (EPAR): Anagrelide Mylan, Anagrelide hydrochloride, Thrombocythemia, Essential, 15/02/2018, , 7, 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): Buccolam, midazolam, Epilepsy, 04/09/2011, 17, Authorised
22/02/2023	Human medicines European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), dinutuximab beta, Neuroblastoma, 08/05/2017, , , , 13, Authorised
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): Ilumetri, tildrakizumab, Psoriasis, 17/09/2018, , 8, Authorised
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	Human medicines European public assessment report (EPAR): Olumiant, baricitinib, Arthritis, Rheumatoid, 13/02/2017, , 10, Authorised
22/02/2023	Human medicines European public assessment report (EPAR): Temodal, temozolomide, Glioma; Glioblastoma, 26/01/1999, 36, 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): Hyrimoz, adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous, 26/07/2018, , , 10, Authorised
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): 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	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	Human medicines European public assessment report (EPAR): Natpar, parathyroid hormone, Hypoparathyroidism, 24/04/2017, , , , 14, Authorised
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): Stocrin, efavirenz, HIV Infections, 28/05/1999, 48, 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): Trodelvy, Sacituzumab govitecan, Breast Neoplasms; Triple Negative Breast Neoplasms, 22/11/2021, , 2, 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): Verzenios, abemaciclib, Breast Neoplasms, 26/09/2018, , 9, Authorised
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	Other: Languages on this website
21/02/2023	Other: Origio - Procedural steps and scientific information after initial consultation
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 1.6.16
21/02/2023	Other: CTIS Training materials - Latest updates
21/02/2023	Other: CooperSurgical Inc ART Media - Procedural steps and scientific information after initial consultation
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
21/02/2023	Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), 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), COVID-19 virus infection, 06/01/2021, , , 35, Authorised
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	Human medicines European public assessment report (EPAR): Pifeltro, doravirine, HIV Infections, 22/11/2018, , 7, Authorised
20/02/2023	Human medicines European public assessment report (EPAR): Delstrigo, doravirine, lamivudine, tenofovir disoproxil fumarate, HIV Infections, 22/11/2018, , 10, Authorised
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): AZD8233 sodium, PCSK9-targeted, antisense oligonucleotide (ASO), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0465/2021
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	Human medicines European public assessment report (EPAR): Tezspire, tezepelumab, Asthma, 19/09/2022, , 2, Authorised
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): Akynzeo, netupitant, palonosetron hydrochloride, Vomiting; Neoplasms; Nausea; Cancer, 27/05/2015, 15, Authorised
20/02/2023	Human medicines European public assessment report (EPAR): Nexpovio, Selinexor, Multiple Myeloma, 26/03/2021, , 7, Authorised
20/02/2023	Human medicines European public assessment report (EPAR): Piqray, Alpelisib, Breast Neoplasms, 27/07/2020, , 8, Authorised
20/02/2023	Human medicines European public assessment report (EPAR): Cuprior, Trientine tetrahydrochloride, Hepatolenticular Degeneration, 05/09/2017, 6, Authorised
20/02/2023	Human medicines European public assessment report (EPAR): Oxbryta, Voxelotor, Anemia; Anemia, Hemolytic; Anemia, Sickle Cell, 14/02/2022, , , 2, Authorised
20/02/2023	Human medicines European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS), nitisinone, Tyrosinemias, 24/08/2017, , 6, Authorised
20/02/2023	Opinion/decision on a Paediatric investigation plan (PIP): Spikevax (previously COVID-19 Vaccine Moderna), mRNA that encodes for the pre-fusion stabilized spike glycoprotein of SARS-CoV-2 (mRNA-1273), PM: decision on the application for modification of an agreed PIP, P/0444/2021
20/02/2023	Referral: Procaine benzylpenicillin , Article 82, Under evaluation, 18/02/2022, 20/02/2023
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): Yselty, linzagolix choline, Leiomyoma, 14/06/2022, , 2, 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): Epidyolex, Cannabidiol, Lennox Gastaut Syndrome; Epilepsies, Myoclonic, 19/09/2019, , 13, Authorised
20/02/2023	Human medicines European public assessment report (EPAR): Remsima, infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid, 10/09/2013, , 32, 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	Human medicines European public assessment report (EPAR): Nulibry, fosdenopterin hydrobromide dihydrate, Metal Metabolism, Inborn Errors, 15/09/2022, , , 1, Authorised
20/02/2023	Human medicines European public assessment report (EPAR): Velmetia, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 16/07/2008, 35, 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	Human medicines European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva, SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection, 24/06/2022, , 5, Authorised
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	Human medicines European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen), adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection, 11/03/2021, , , 28, Authorised
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	Human medicines European public assessment report (EPAR): Amglidia, glibenclamide, Diabetes Mellitus, 24/05/2018, , 5, Authorised
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 ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Scientific guideline
16/02/2023	Human medicines European public assessment report (EPAR): Accofil, filgrastim, Neutropenia, 17/09/2014, , 13, Authorised
16/02/2023	Human medicines European public assessment report (EPAR): CoAprovel, irbesartan, hydrochlorothiazide, Hypertension, 14/10/1998, 46, Authorised
16/02/2023	Human medicines European public assessment report (EPAR): Aprovel, irbesartan, Hypertension, 26/08/1997, 47, Authorised
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	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	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): Iscover, clopidogrel, Stroke; Peripheral Vascular Diseases; Atrial Fibrillation; Myocardial Infarction; Acute Coronary Syndrome, 14/07/1998, 49, 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): Mirvaso, brimonidine tartrate, Skin Diseases, 20/02/2014, 12, 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	Human medicines European public assessment report (EPAR): Byfavo, remimazolam, Conscious Sedation, 26/03/2021, , 4, Authorised
16/02/2023	Human medicines European public assessment report (EPAR): Darunavir Krka, darunavir, HIV Infections, 26/01/2018, , 9, Authorised
16/02/2023	Human medicines European public assessment report (EPAR): DuoPlavin, clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome; Myocardial Infarction, 14/03/2010, 28, Authorised
16/02/2023	Template or form: Day 80 assessment report - Overview and D120 LOQ template with guidance - Rev. 02.23
16/02/2023	Human medicines European public assessment report (EPAR): Enhertu, trastuzumab deruxtecan, Breast Neoplasms, 18/01/2021, , , 10, Authorised
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): Ondexxya, andexanet alfa, Drug-Related Side Effects and Adverse Reactions, 26/04/2019, , , 13, Authorised
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	3Rs Working Party (3RsWP) plenary meeting - Public session on the 2023 work plan , Online, from 28/02/2023 to 01/03/2023
15/02/2023	Human medicines European public assessment report (EPAR): Plavix, clopidogrel hydrogen sulfate, Stroke; Peripheral Vascular Diseases; Atrial Fibrillation; Myocardial Infarction; Acute Coronary Syndrome, 15/07/1998, 48, Authorised
15/02/2023	Work programme: Work plan for the Biologics Working Party (BWP) for 2023
15/02/2023	Other: Floseal haemostatic matrix (Floseal VH S/D) - Procedural steps and scientific information after initial consultation
15/02/2023	Other: Questions and answers by the Query Management Working Group on CTIS and the CTR
15/02/2023	Procedures for monograph and list entry establishment
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 - Call for data: Call for scientific data for the use in HMPC assessment work on Pruni cerasi stipites
15/02/2023	Human medicines European public assessment report (EPAR): Prevenar 13, 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 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F, Pneumococcal Infections; Immunization, 09/12/2009, 43, Authorised
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	Human medicines European public assessment report (EPAR): NexoBrid, proteolytic enzymes enriched in bromelain, Debridement, 18/12/2012, , 14, Authorised
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)