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29/04/2022 Human medicines European public assessment report (EPAR): Ultomiris, ravulizumab, Hemoglobinuria, Paroxysmal, 02/07/2019, Additional monitoring, 8, Authorised
29/04/2022 Human medicines European public assessment report (EPAR): Lydisilka, estetrol monohydrate, drospirenone, Contraceptives, Oral, 19/05/2021, 2, Authorised
29/04/2022 EMA regular press briefing on COVID-19 , Online, from 05/05/2022 to 05/05/2022
29/04/2022 Other: Decision of the Executive Director on fee reductions for scientific advice requests for medicines for COVID-19 not covered by Article 16(2) of Regulation (EU) 2022/123
29/04/2022 Referral: Nasolam and associated names , midazolam, Article 29(4) referrals, European Commission final decision, 27/01/2022, 01/04/2022, 29/04/2022
29/04/2022 Orphan designation: Gadolinium-chelated polysiloxane nanoparticles for the: Treatment of pancreatic cancer, 24/02/2022, Positive
29/04/2022 Orphan designation: aldesleukin for the: Treatment of amyotrophic lateral sclerosis, 24/02/2022, Positive
29/04/2022 Orphan designation: [Ala1,3,12,Gln10,Arg11,Trp14]PTH(1-14)/[Ala18,22, Lys26]PTHrP(15-36)COOH for the: Treatment of hypoparathyroidism, 24/02/2022, Positive
29/04/2022 Orphan designation: Bovactant for the: Treatment of respiratory distress syndrome, 24/02/2022, Positive
29/04/2022 Direct healthcare professional communication (DHPC): Natpar (parathyroid hormone) 100 micrograms/dose powder and solvent for solution for injection: expected shortage from June 30th, 2022, Active substance: parathyroid hormone, DHPC type: Medicine shortage, Last updated: 29/04/2022
29/04/2022 Human medicines European public assessment report (EPAR): Drovelis, drospirenone, estetrol monohydrate, Contraceptives, Oral, 19/05/2021, 2, Authorised
28/04/2022 Human medicines European public assessment report (EPAR): Byfavo, remimazolam, Conscious Sedation, 26/03/2021, Additional monitoring, 1, Authorised
28/04/2022 Orphan designation: Pyridoxal 5'-phosphate for the: Treatment of pyridoxamine 5'-phosphate oxidase deficiency, 24/02/2022, Positive
28/04/2022 Orphan designation: Cedazuridine, decitabine for the: Treatment of acute myeloid leukaemia, 10/12/2021, Positive
28/04/2022 Orphan designation: Vatiquinone for the: Treatment of mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes, 24/02/2022, Positive
28/04/2022 Orphan designation: Valemetostat tosilate for the: Treatment of peripheral T-cell lymphoma, 24/02/2022, Positive
28/04/2022 Orphan designation: Chimeric peptide of human glucagon-like peptide-1, glucagon and gastric inhibitory polypeptide analogues linked to a human immunoglobulin Fc fragment for the: Treatment of primary sclerosing cholangitis, 10/12/2021, Positive
28/04/2022 Orphan designation: 6-(4-(tert-butyl)phenoxy)pyridin-3-amine for the: Treatment of acute lymphoblastic leukaemia, 10/12/2021, Positive
28/04/2022 Human medicines European public assessment report (EPAR): Poteligeo, Mogamulizumab, Sezary Syndrome; Mycosis Fungoides, 22/11/2018, Orphan, Additional monitoring, 5, Authorised
28/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Setmelanotide, PM: decision on the application for modification of an agreed PIP, P/0215/2021
28/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab, PM: decision on the application for modification of an agreed PIP, P/0239/2021
28/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto, Venetoclax, PM: decision on the application for modification of an agreed PIP, P/0217/2021
28/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab, PM: decision on the application for modification of an agreed PIP, P/0238/2021
28/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Liquid ethanolic extract 30 per cent (w/w) of Allium cepa L. (fresh bulb) and Citrus limon (L.) Burm. f. (fresh fruit),Paullinia cupana Kunth,Theobroma cacao L., PM: decision on the application for modification of an agreed PIP, P/0220/2021
28/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Zeposia, Ozanimod (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0233/2021
28/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Zynteglo, betibeglogene autotemcel, PM: decision on the application for modification of an agreed PIP, P/0232/2021
28/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Zynquista, Sotagliflozin, PM: decision on the application for modification of an agreed PIP, P/0226/2021
28/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Opdivo, nivolumab, PM: decision on the application for modification of an agreed PIP, P/0237/2021
28/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Constella, linaclotide, PM: decision on the application for modification of an agreed PIP, P/0216/2021
28/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Tamiflu, Oseltamivir (phosphate), PM: decision on the application for modification of an agreed PIP, P/0241/2021
28/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Synthetic hypericin, W: decision granting a waiver in all age groups for all conditions or indications, P/0218/2021
28/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Immunoglobulin G4 [449-cysteine],anti-(human vascular endothelial growth factor A) (human-Mus musculus monoclonal OG1950 gamma-4-chain),disulfide with human-Mus musculus monoclonal OG1950 kappa-chain,(232 - 232’),(235 - 235’)-bis(disulfide) with immunoglobulin G4 anti-(human vascular endothelial growth factor A) (human-Mus musculus monoclonal OG1950 gamma-4-chain) disulfide with human-Mus musculus monoclonal OG1950 kappa-chain,449-thioether with 1,1’-[2-[11,11-bis[15-bromo-11,11-bis[(2-bromo-2-methyl- 1-oxopropoxy)methyl]-15-methyl-3,7,14-trioxo-9,13-dioxa-2,6-diazahexadec-1-yl]-44-(3-mercapto- 2,5-dioxo-1-pyrrolidinyl)-4,8,26,42-tetraoxo-2,13,16,19,22,29,32,35,38-nonaoxa-5,9,25,41- tetraazatetratetracont-1-yl]-2-[(2-bromo-2-methyl-1-oxopropoxy)methyl]-1,3-propanediyl] bis(2- bromo-2-methylpropanoate) core 9-arm star compd. with 4-hydroxy-N,N,N,10-tetramethyl-9-oxo- 3,5,8-trioxa-4-phosphaundec-10-en-1-aminium inner salt 4-oxide homopolymer (KSI-301), W: decision granting a waiver in all age groups for all conditions or indications, P/0219/2021
28/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Iscalimab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0222/2021
28/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Human plasma derived C1-inhibitor (OCTA-C1-INH), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0225/2021
28/04/2022 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 19-22 April 2022
28/04/2022 Regulatory and procedural guideline: Procedure for the nomination and appointment of co-opted members of the Medicinal Products for Human Use (CHMP), the Committee for Veterinary Medicinal Products (CVMP) and the Committee on Herbal Medicinal Products (HMPC) (effective from 02/05/2022)
26/04/2022 Periodic safety update single assessment: Human plasma protease C1 inhibitor : List of nationally authorised medicinal products - PSUSA/00010163/202108
26/04/2022 Human medicines European public assessment report (EPAR): Pregabalin Mylan Pharma, pregabalin, Anxiety Disorders; Neuralgia; Epilepsy, 25/06/2015, Generic, 7, Withdrawn
26/04/2022 Periodic safety update single assessment: Gadobutrol : List of nationally authorised medicinal products - PSUSA/00001502/202108
26/04/2022 Human medicines European public assessment report (EPAR): Brilique, ticagrelor, Peripheral Vascular Diseases; Acute Coronary Syndrome, 03/12/2010, 20, Authorised
26/04/2022 Human medicines European public assessment report (EPAR): Remicade, infliximab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Psoriasis; Crohn Disease; Arthritis, Psoriatic; Colitis, Ulcerative, 13/08/1999, 60, Authorised
26/04/2022 Human medicines European public assessment report (EPAR): Sibnayal, Potassium citrate monohydrated, Potassium hydrogen carbonate, Acidosis, Renal Tubular, 30/04/2021, 1, Authorised
26/04/2022 Human medicines European public assessment report (EPAR): Revolade, Eltrombopag, Purpura, Thrombocytopenic, Idiopathic, 11/03/2010, 30, Authorised
26/04/2022 Human medicines European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG, influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks, 16/10/2009, Exceptional circumstances, 7, Authorised
26/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): sotatercept, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0227/2021
26/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Atropine sulfate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0229/2021
26/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Deferoxamine (mesylate),histidine,tryptophan,aspartic acid,n-acetyl-histidine (monohydrate),glycine,alpha-ketoglutaric acid,arginine,potassium chloride,magnesium chloride (hexahydrate),calcium chloride (dihydrate),sodium chloride,alanine,3,4-dimethoxy-N-methylbenzohydroxamic, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0228/2021
26/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Savolitinib, W: decision granting a waiver in all age groups for all conditions or indications, P/0231/2021
26/04/2022 Human medicines European public assessment report (EPAR): Arsenic trioxide medac, Arsenic trioxide, Leukemia, Promyelocytic, Acute, 17/09/2020, Generic, 2, Authorised
26/04/2022 Clinical Trials Information System (CTIS) bitesize talk: Requests for information , Online, 14:00 - 15:30 Amsterdam time (CET), from 28/04/2022 to 28/04/2022
26/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Talzenna, talazoparib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0224/2021
26/04/2022 Human medicines European public assessment report (EPAR): RoActemra, tocilizumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Cytokine Release Syndrome; Giant Cell Arteritis; COVID-19 virus infection, 15/01/2009, 38, Authorised
26/04/2022 Human medicines European public assessment report (EPAR): Ofev, nintedanib, Idiopathic Pulmonary Fibrosis, 14/01/2015, Accelerated assessment, 22, Authorised
26/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Erdafitinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0223/2021
26/04/2022 Periodic safety update single assessment: Gadobenic acid : List of nationally authorised medicinal products - PSUSA/00001500/202108
26/04/2022 Orphan designation: sotatercept for the: Treatment of pulmonary arterial hypertension, 09/12/2020, Positive
26/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab, PM: decision on the application for modification of an agreed PIP, P/0230/2021
25/04/2022 Human medicines European public assessment report (EPAR): Voriconazole Accord, voriconazole, Aspergillosis; Candidiasis; Mycoses, 16/05/2013, Generic, 16, Authorised
25/04/2022 Human medicines European public assessment report (EPAR): Voriconazole Hikma (previously Voriconazole Hospira), voriconazole, Bacterial Infections and Mycoses; Aspergillosis; Candidiasis, 27/05/2015, Generic, 11, Authorised
25/04/2022 Newsletter: CTIS newsflash - 22 April 2022
25/04/2022 Regulatory and procedural guideline: Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications - 2022-2023
25/04/2022 Submission deadlines for orphan designations
25/04/2022 Human medicines European public assessment report (EPAR): Capecitabine Medac, capecitabine, Colorectal Neoplasms, 19/11/2012, Generic, 12, Authorised
25/04/2022 News and press releases: European Immunization Week 2022: Statement by Executive Director Emer Cooke - Why vaccines contribute to a “Long Life for All”
25/04/2022 Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein for the: Treatment of acute myeloid leukaemia, 09/10/2015, Positive
25/04/2022 Orphan designation: Autologous CD34+ hematopoietic stem and progenitor cells transfected with zinc finger nuclease mRNAs SB-mRENH1 and SB-mRENH2 for the: Treatment of sickle cell disease, 19/02/2021, Positive
25/04/2022 Human medicines European public assessment report (EPAR): Simbrinza, brinzolamide, brimonidine tartrate, Ocular Hypertension; Glaucoma, Open-Angle, 18/07/2014, 9, Authorised
25/04/2022 Human medicines European public assessment report (EPAR): Zinplava, bezlotoxumab, Enterocolitis, Pseudomembranous, 18/01/2017, 8, Authorised
25/04/2022 Human medicines European public assessment report (EPAR): Duloxetine Mylan, duloxetine, Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major; Anxiety Disorders, 19/06/2015, Generic, 17, Authorised
25/04/2022 Human medicines European public assessment report (EPAR): Vaxneuvance, pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections, 13/12/2021, Additional monitoring, 1, Authorised
25/04/2022 News and press releases: EMA business hours over King's Day holiday
25/04/2022 Report: Medicinal products for human use: monthly figures - March 2022
22/04/2022 Annex to CHMP highlights: Start of Union reviews adopted during the CHMP meeting of 19-22 April 2022
22/04/2022 Clinical Trials Information System (CTIS): Walk-in clinic , Online, 15:00 - 16:00 Amsterdam time (CEST), from 22/04/2022 to 22/04/2022
22/04/2022 Human medicines European public assessment report (EPAR): Kimmtrak, tebentafusp, Uveal Neoplasms, 01/04/2022, Orphan, Additional monitoring, Authorised
22/04/2022 Orphan designation: Tebentafusp for the: Treatment of uveal melanoma, 19/02/2021, Positive
22/04/2022 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2022
22/04/2022 News and press releases: Facilitating global access to diabetes treatments for non-EU patients
22/04/2022 Summary of opinion: Retsevmo, selpercatinib, 22/04/2022, Positive
22/04/2022 Withdrawn application: Miplyffa , arimoclomol, Date of withdrawal: 22/03/2022, Initial authorisation
22/04/2022 Regulatory and procedural guideline: Procedural advice for veterinary vaccine antigen master file (VAMF) certification
22/04/2022 News and press releases: EMA starts review of cancer medicine Rubraca
22/04/2022 Regulatory and procedural guideline: Procedural advice on the accelerated assessment of marketing authorisation applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6
22/04/2022 Minutes: Minutes of the CVMP meeting of 15-16 March 2022
21/04/2022 Orphan designation: N-[1-((5-cyanopyridin-2-yl)methyl)-1H-pyrazol- 3-yl]-2-[4-(1-(trifluoromethyl)cyclopropyl) phenyl]acetamide for the: Treatment of epileptic encephalopathy with continuous spike-and-wave during sleep, 10/12/2021, Positive
21/04/2022 Pharmacovigilance: Overview
21/04/2022 Human medicines European public assessment report (EPAR): NutropinAq, somatropin, Turner Syndrome; Dwarfism, Pituitary, 15/02/2001, 19, Authorised
21/04/2022 Human medicines European public assessment report (EPAR): Nustendi, Bempedoic acid, Ezetimibe, Hypercholesterolemia; Dyslipidemias, 27/03/2020, Additional monitoring, 5, Authorised
21/04/2022 Periodic safety update single assessment: Cetirizine pseudoephedrine : List of nationally authorised medicinal products - PSUSA/00000629/202108
21/04/2022 Human medicines European public assessment report (EPAR): Imlygic, talimogene laherparepvec, Melanoma, 16/12/2015, 11, Authorised
21/04/2022 Referral: Lidocain/Prilocain Idetec and associated names , lidocaine, prilocaine, Lidocaïne / Prilocaïne 5% Focus, Crème, Article 29(4) referrals, Opinion provided by Committee for Medicinal Products for Human Use, 14/10/2021, 21/04/2022
21/04/2022 Referral: Etifoxine-containing medicinal products , etifoxine, Stresam, Article 31 referrals, European Commission final decision, 24/06/2021, 24/03/2022, 21/04/2022
21/04/2022 Agenda: Agenda - CHMP agenda of the 19-22 April 2022 meeting
21/04/2022 Human medicines European public assessment report (EPAR): Pregabalin Accord, pregabalin, Anxiety Disorders; Epilepsy, 28/08/2015, Generic, 14, Authorised
21/04/2022 Human medicines European public assessment report (EPAR): Verzenios, abemaciclib, Breast Neoplasms, 26/09/2018, Additional monitoring, 8, Authorised
20/04/2022 Human medicines European public assessment report (EPAR): Nubeqa, darolutamide, Prostatic Neoplasms, Castration-Resistant, 27/03/2020, Additional monitoring, 3, Authorised
20/04/2022 Human medicines European public assessment report (EPAR): Memantine Merz, memantine hydrochloride, Alzheimer Disease, 22/11/2012, 7, Authorised
20/04/2022 Regulatory and procedural guideline: Compilation of Union procedures on inspections and exchange of information
20/04/2022 Other: Outcome of written procedures finalised during the period from 25 November 2021 to 18 February 2022
20/04/2022 Other: Summary of transfers of appropriations in budgets 2021 and 2022
20/04/2022 Report: 2021 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission
20/04/2022 Minutes: Minutes of the 114th meeting of the Management Board: 15-16 December 2021
20/04/2022 Work programme: Work plan for the Pharmacovigilance Inspectors Working Group for 2021-2024
20/04/2022 ICH Q9 Quality risk management
20/04/2022 Overview of comments: Overview of comments received on ICH guideline Q9 (R1) on quality risk management (EMA/CHMP/ICH/24235/2006)
20/04/2022 Report: Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2021
20/04/2022 Orphan designation: Ribonucleoprotein complex composed of two sgRNA and a Cas9 nuclease targeting the human COL7A1 gene for the: Treatment of epidermolysis bullosa, 10/12/2021, Positive
20/04/2022 Orphan designation: copper (64Cu) chloride for the: Treatment of glioma, 10/12/2021, Positive
20/04/2022 Other: Policy 72: European Medicines Agency policy on handling of information from external sources disclosing alleged improprieties concerning EMA activities related to the authorisation, supervision and maintenance of human a...
20/04/2022 Periodic safety update single assessment: Tuberculin purified protein derivative : List of nationally authorised medicinal products - PSUSA/00003063/202109
20/04/2022 Periodic safety update single assessment: Penciclovir : List of nationally authorised medicinal products - PSUSA/00002333/202108
20/04/2022 Human medicines European public assessment report (EPAR): Nulojix, belatacept, Graft Rejection; Kidney Transplantation, 17/06/2011, 18, Authorised
19/04/2022 Sixth Nitrosamine Implementation Oversight Group (NIOG) meeting , Online, from 26/04/2022 to 26/04/2022
19/04/2022 Orphan designation: Atrasentan for the: Treatment of primary IgA nephropathy, 10/12/2021, Positive
19/04/2022 Orphan designation: Crofelemer for the: Treatment of short bowel syndrome, 10/12/2021, Positive
19/04/2022 Orphan designation: 3-(ethoxydifluoromethyl)-6-(5-fluoro-6-(2,2,2-trifluoroethoxy)pyridin-3-yl)-[1,2,4]triazolo[4,3-a]pyrazine for the: Treatment of SCN8A developmental and epileptic encephalopathy, 10/12/2021, Positive
19/04/2022 News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 April 2022
19/04/2022 ICH E8 General considerations for clinical studies
19/04/2022 Report: EMA / eligible healthcare professional organisations policy officers’ group (HCP POG) pilot: one-year review
19/04/2022 Other: PRAC strategy on measuring the impact of pharmacovigilance activities
19/04/2022 Orphan designation: Entinostat for the: Treatment of Hodgkin's lymphoma, 10/06/2010, Positive
13/04/2022 Template or form: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification
13/04/2022 Report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 28-30 March 2022
13/04/2022 Scientific guideline: Points to consider on the impact of the war in Ukraine on methodological aspects of ongoing clinical trials
13/04/2022 Impact of the war in Ukraine on methodological aspects of ongoing clinical trials
13/04/2022 Orphan designation: 3-(ethoxydifluoromethyl)-6-(5-fluoro-6-(2,2,2-trifluoroethoxy)pyridin-3-yl)-[1,2,4]triazolo[4,3-a]pyrazine for the: Treatment of SCN2A developmental and epileptic encephalopathy, 10/12/2021, Positive
13/04/2022 Orphan designation: Anti-(endothelin-1 receptor subtype A) IgG4 humanised monoclonal antibody for the: Treatment of pulmonary arterial hypertension, 10/12/2021, Positive
13/04/2022 Orphan designation: Retinol palmitate for the: Prevention of bronchopulmonary dysplasia, 10/12/2021, Positive
13/04/2022 Other: Compilation of terms and definitions for Cannabis-derived medicinal products
13/04/2022 Regulatory and procedural guideline: Detailed guidance on ICSRs in the context of COVID-19 - Validity and coding of ICSRs
13/04/2022 Orphan designation: polyethylene glycol-modified human recombinant truncated cystathionine beta-synthase (pegtibatinase) for the: Treatment of homocystinuria, 30/05/2016, Positive
13/04/2022 Human medicines European public assessment report (EPAR): Oxbryta, Voxelotor, Anemia; Anemia, Hemolytic; Anemia, Sickle Cell, 14/02/2022, Orphan, Additional monitoring, 1, Authorised
13/04/2022 COVID-19 vaccine safety update: COVID-19 vaccines - Safety update: 13 April 2022
13/04/2022 Orphan designation: Vatiquinone for the: Treatment of Alpers-Huttenlocher syndrome, 10/12/2021, Positive
13/04/2022 Herbal medicinal product: Rosae flos, Rosae flos, F: Assessment finalised
13/04/2022 Herbal medicinal product: Ricini oleum, Ricini oleum, F: Assessment finalised
13/04/2022 Orphan designation: Mocravimod for the: Treatment in haematopoietic stem cell transplantation, 15/10/2021, Positive
13/04/2022 Orphan designation: Autologous T cells ex vivo modified with a lentiviral vector encoding a chimeric antigen receptor specific for CD1a for the: Treatment of acute lymphoblastic leukaemia, 10/12/2021, Positive
13/04/2022 Herbal medicinal product: Sennae folium, Sennae folium, F: Assessment finalised
13/04/2022 Orphan designation: Macitentan for the: Treatment of chronic thromboembolic pulmonary hypertension, 10/12/2021, Positive
13/04/2022 Orphan designation: Garadacimab for the: Treatment of hereditary angioedema, 10/12/2021, Positive
13/04/2022 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Symphyti radix - Revision 1
13/04/2022 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Sisymbrii officinalis herba - Revision 1
13/04/2022 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Sideritis herba - Revision 1
13/04/2022 Human medicines European public assessment report (EPAR): Eptifibatide Accord, eptifibatide, Myocardial Infarction, 11/01/2016, Generic, 5, Authorised
13/04/2022 Herbal medicinal product: Sisymbrii officinalis herba, Sisymbrii officinalis herba, F: Assessment finalised
13/04/2022 Herbal medicinal product: Symphyti radix, Symphyti radix, F: Assessment finalised
13/04/2022 Herbal medicinal product: Sideritis herba, Sideritis herba, F: Assessment finalised
12/04/2022 Template or form: QRD combined label-leaflet annotated template (English) v.9.0
12/04/2022 Template or form: QRD combined label-leaflet template v.9.0
12/04/2022 Minutes: Meeting summary - European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting on 2-3 March 2022
12/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Tanezumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0070/2018
12/04/2022 Periodic safety update single assessment: Benazepril / hydrochlorothiazide : List of nationally authorised medicinal products for variation - PSUSA/00000314/202105
12/04/2022 Periodic safety update single assessment: Benazepril / hydrochlorothiazide : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000314/202105
12/04/2022 PIP - Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision: Tanezumab - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision
12/04/2022 Report: PDCO meeting report of opinions on paediatric investigation plans and other activities 22-25 February 2022
12/04/2022 Parallel joint scientific consultation with regulators and health technology assessment bodies
12/04/2022 Work programme: European collaboration between regulators and health technology assessment bodies - Joint work plan (2021-2023) between EMA and European HTA bodies facilitated through EUnetHTA21
12/04/2022 News and press releases: EMA and the EUnetHTA 21 consortium set priorities for their collaboration
12/04/2022 Health technology assessment bodies
12/04/2022 Orphan designation: Encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotrophic factor for the: Treatment of retinitis pigmentosa, 24/01/2013, Positive
12/04/2022 Human medicines European public assessment report (EPAR): Dexmedetomidine Accord, dexmedetomidine, Premedication, 13/02/2020, Generic, 4, Authorised
12/04/2022 Orphan designation: Encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotropic factor for the: Treatment of macular telangiectasia type 2, 08/11/2012, Positive
12/04/2022 News and press releases: EMA business hours over Easter holiday
12/04/2022 Human medicines European public assessment report (EPAR): Ibandronic acid Accord, ibandronic acid, Wounds and Injuries; Breast Diseases; Neoplastic Processes; Calcium Metabolism Disorders; Water-Electrolyte Imbalance, 18/11/2012, Generic, 13, Authorised
11/04/2022 Human medicines European public assessment report (EPAR): Byooviz, ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative, 18/08/2021, Additional monitoring, Biosimilar, 2, Authorised
11/04/2022 Periodic safety update single assessment: Gadopentetic acid : List of nationally authorised medicinal products - PSUSA/00001504/202108
11/04/2022 Opinion/decision on a Paediatric investigation plan (PIP): Zorecimeran, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0212/2021
11/04/2022 Veterinary medicines European public assessment report (EPAR): Purevax RCPCh FeLV, attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97), attenuated Chlamydophila felis (905 strain), 23/02/2005, 15, Authorised
11/04/2022 PIP - Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision: Zorecimeran - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision
11/04/2022 Other: European Medicines Agency data protection notice concerning the Veterinary Info Day meeting on 12-13 May 2022
11/04/2022 Template or form: Innovation Task Force (ITF) briefing meeting request form
11/04/2022 Procurement: Ex ante publicity of a negotiated procedure - EMA/2022/09/IT - Transfer of registration of 21 public domain names from the current registrar and extension of their registration to 31/12/2024
11/04/2022 Newsletter: CTIS newsflash - 8 April 2022
11/04/2022 Newsletter: Human medicines highlights - April 2022
11/04/2022 Agenda: Agenda - Enpr-EMA Coordinating Group and networks meeting
11/04/2022 Human medicines European public assessment report (EPAR): Toujeo (previously Optisulin), insulin glargine, Diabetes Mellitus, 26/06/2000, 32, Authorised
11/04/2022 Agenda: Agenda - COMP agenda of the 11-13 April 2022 meeting
11/04/2022 Periodic safety update single assessment: Aniracetam : List of nationally authorised medicinal products : PSUSA/00010790/202108
11/04/2022 Agenda: Agenda - CAT agenda of the 11-13 April 2022 meeting
11/04/2022 Agenda: Agenda - CVMP agenda of the 11-13 April 2022 meeting
11/04/2022 Herbal medicinal product: Sennae fructus, Sennae fructus, F: Assessment finalised
11/04/2022 Herbal medicinal product: Rhei radix, Rhei radix, F: Assessment finalised
11/04/2022 Herbal medicinal product: Aloes folii succus siccatus, Aloes folii succus siccatus, F: Assessment finalised
11/04/2022 Human medicines European public assessment report (EPAR): Multaq, dronedarone, Atrial Fibrillation, 25/11/2009, 17, Authorised
11/04/2022 Herbal medicinal product: Frangulae cortex, Frangulae cortex, F: Assessment finalised
11/04/2022 Orphan designation: Leniolisib for the: Treatment of activated phosphoinositide 3-kinase delta syndrome, 19/10/2020, Positive
11/04/2022 Orphan designation: 26 base synthetic single-stranded fully phosphorothioated 2'-O-methyl-RNA and DNA mixmer oligonucleotide-based compound for the: Treatment of Dravet syndrome, 27/02/2017, Positive
11/04/2022 Periodic safety update single assessment: Rilmenidine : List of nationally authorised medicinal products - PSUSA/00002643/202108
08/04/2022 Paediatric medicines: Overview
08/04/2022 Human medicines European public assessment report (EPAR): Abilify, aripiprazole, Schizophrenia; Bipolar Disorder, 04/06/2004, 49, Authorised
08/04/2022 Other: Draft guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial Information System (CTIS)
08/04/2022 Periodic safety update single assessment: Gadoteridol : List of nationally authorised medicinal products - PSUSA/00001507/202108
08/04/2022 Withdrawn application: Zektayos - Hepjuvo, obeticholic acid, Date of withdrawal: 09/12/2021, Initial authorisation
08/04/2022 Human medicines European public assessment report (EPAR): Cabazitaxel Accord, cabazitaxel, Prostatic Neoplasms, Castration-Resistant, 28/08/2020, Generic, 2, Authorised
08/04/2022 Orphan designation: [Gly2]-recombinant human glucagon-like peptide for the: Treatment of short bowel syndrome, 12/12/2001, Positive
08/04/2022 Orphan designation: (5R,5aR,8aR,9S)-9-[[4,6-O-[(R)-Ethylidene]-β-D-glucopyranosyl]-oxy]-5-(4-({[(2,2-dimethyl-1,3-dioxolan-4-yl)methoxy]carbonyl}oxy)-3,5-dimethoxyphenyl)-5,8,8a,9-tetrahydroisobenzofuro[5,6-f][1,3]benzodioxol-6(5aH)-one (etoposide toniribate) for the: Treatment of biliary tract cancer, 04/06/2014, Positive
08/04/2022 Report: Report on budgetary and financial management - financial year 2021
08/04/2022 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022
08/04/2022 Orphan designation: Loncastuximab tesirine for the: Treatment of diffuse large B-cell lymphoma, 20/08/2021, Positive
08/04/2022 Periodic safety update single assessment: Buserelin : List of nationally authorised medicinal products - PSUSA/00000462/202108
08/04/2022 Human medicines European public assessment report (EPAR): Xagrid, Anagrelide, Thrombocythemia, Essential, 15/11/2004, 38, Authorised
08/04/2022 Report: Applications for new human medicines under evaluation by the CHMP: April 2022
08/04/2022 Human medicines European public assessment report (EPAR): Nilemdo, Bempedoic acid, Hypercholesterolemia; Dyslipidemias, 01/04/2020, Additional monitoring, 6, Authorised
08/04/2022 Report: Annual report on the use of the special contribution for orphan medicinal products - 2021
08/04/2022 Human medicines European public assessment report (EPAR): Palonosetron Hospira, palonosetron hydrochloride, Nausea; Vomiting; Cancer, 08/04/2016, Generic, 4, Withdrawn
08/04/2022 Opinion on medicine for use outside EU: Umbipro, chlorhexidine digluconate, Soft Tissue Infections, 28/04/2016, Withdrawn opinion
07/04/2022 Periodic safety update single assessment: Allergen for therapy: Dermatophagoides pteronyssinus / Dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure) : List of nationally authorised medicinal products - PSUSA/00010582/202109
07/04/2022 Periodic safety update single assessment: Finasteride : List of nationally authorised medicinal products - PSUSA/00001392/202108
07/04/2022 Regulatory and procedural guideline: Guidance on Irish language derogation ending on 1 January 2022
07/04/2022 Orphan designation: Allogeneic donor-derived ex-vivo expanded T lymphocytes transduced with a retroviral vector containing inducible caspase 9 and truncated CD19 for the: Treatment in haematopoietic stem cell transplantation, 27/06/2016, Withdrawn
07/04/2022 Orphan designation: Rimiducid for the: Treatment of graft-versus-host disease, 30/05/2016, Withdrawn
07/04/2022 Human medicines European public assessment report (EPAR): Insulin lispro Sanofi, insulin lispro, Diabetes Mellitus, 19/07/2017, Additional monitoring, Biosimilar, 7, Authorised
07/04/2022 Human medicines European public assessment report (EPAR): Quofenix, delafloxacin meglumine, Community-Acquired Infections, 16/12/2019, Additional monitoring, 4, Authorised
07/04/2022 Human medicines European public assessment report (EPAR): Febuxostat Krka, febuxostat, Hyperuricemia; Gout, 28/03/2019, Generic, 3, Authorised
07/04/2022 Veterinary medicines European public assessment report (EPAR): Purevax RCP FeLV, attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated feline panleucopenia virus (PLI IV), FeLV recombinant canarypox virus (vCP97), 23/02/2005, 15, Authorised
07/04/2022 Periodic safety update single assessment: Paracetamol (IV formulation) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002311/202105
07/04/2022 Human medicines European public assessment report (EPAR): Abecma, idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases, 18/08/2021, Orphan, Additional monitoring, Conditional approval, 4, Authorised
07/04/2022 Human medicines European public assessment report (EPAR): Obizur, susoctocog alfa, Hemophilia A, 11/11/2015, Additional monitoring, Exceptional circumstances, 9, Authorised
07/04/2022 Other: Mandate of the Working Group on Active Substance Master File Procedures
07/04/2022 Other: European Medicines Agency’s Data Protection Notice for the Microsoft Edge
07/04/2022 Human medicines European public assessment report (EPAR): Lorviqua, Lorlatinib, Carcinoma, Non-Small-Cell Lung, 06/05/2019, Additional monitoring, Conditional approval, 9, Authorised
06/04/2022 Veterinary medicines European public assessment report (EPAR): Purevax RCPCh, attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), attenuated Chlamydophila felis (905 strain), attenuated feline panleucopenia virus (PLI IV), 23/02/2005, 17, Authorised
06/04/2022 Veterinary medicines European public assessment report (EPAR): Purevax RCP, attenuated feline panleucopenia virus (PLI IV), 23/02/2005, 17, Authorised
06/04/2022 Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Stomach Neoplasms; Breast Neoplasms, 09/02/2018, Additional monitoring, Biosimilar, 16, Authorised
06/04/2022 Human medicines European public assessment report (EPAR): Daptomycin Hospira, daptomycin, Soft Tissue Infections; Skin Diseases, Bacterial, 22/03/2017, Generic, 13, Authorised
06/04/2022 Human medicines European public assessment report (EPAR): Dukoral, recombinant cholera toxin B subunit, vibrio cholerae 01, Cholera; Immunization, 28/04/2004, 14, Authorised
06/04/2022 Periodic safety update single assessment: Remifentanil : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002617/202105
06/04/2022 Periodic safety update single assessment: Tiagabine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002942/202106
06/04/2022 News and press releases: ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines
06/04/2022 Periodic safety update single assessment: Tiagabine : List of nationally authorised medicinal products - PSUSA/00002942/202106
06/04/2022 Orphan designation: Molgramostim for the: Treatment of acute respiratory distress syndrome (ARDS), 27/06/2016, Positive
06/04/2022 Orphan designation: Granulocyte-macrophage colony-stimulating factor for the: Treatment of pulmonary alveolar proteinosis, 17/07/2013, Positive
06/04/2022 Orphan designation: Ciprofloxacin for the: Treatment of cystic fibrosis, 24/07/2009, Positive
06/04/2022 Template or form: PRIME eligibility request: applicant’s justification template
06/04/2022 Human medicines European public assessment report (EPAR): Nimvastid, rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease, 11/05/2009, Generic, 9, Authorised
06/04/2022 Minutes: Minutes of the COMP meeting on 15-17 February 2022
06/04/2022 Scientific guideline: Draft ICH guideline E11A on pediatric extrapolation Step 2b
06/04/2022 Good manufacturing practice
06/04/2022 Good clinical practice
06/04/2022 Orphan designation: Multilamellar microvesicle comprising phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol and cholesterol for the: Treatment of cystic fibrosis, 30/08/2011, Withdrawn
06/04/2022 Orphan designation: Rilonacept for the: Treatment of idiopathic pericarditis, 06/01/2021, Positive
06/04/2022 Herbal medicinal product: Urticae radix, Urticae radix, F: Assessment finalised
06/04/2022 Herbal medicinal product: Tiliae flos, Tiliae flos, F: Assessment finalised
06/04/2022 Herbal medicinal product: Rhodiolae roseae rhizoma et radix, Rhodiolae roseae rhizoma et radix, F: Assessment finalised
06/04/2022 Human medicines European public assessment report (EPAR): Foclivia, influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks, 18/10/2009, Exceptional circumstances, 12, Authorised
06/04/2022 Human medicines European public assessment report (EPAR): Emadine, emedastine difumarate, Conjunctivitis, Allergic, 27/01/1999, 25, Authorised
06/04/2022 Other: Orphan medicines figures 2000-2021
06/04/2022 Human medicines European public assessment report (EPAR): Urorec, silodosin, Prostatic Hyperplasia, 29/01/2010, 18, Authorised
05/04/2022 Other: Release notes - production release version 1.6.2 April 2022 - Veterinary Medicinal Products Regulation: Union Product Database