|
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 |
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,  ,  , 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): 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,  , 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): 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): 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,  , 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, , 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): Ofev, nintedanib, Idiopathic Pulmonary Fibrosis, 14/01/2015,  , 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, , 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, , 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, , 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): Duloxetine Mylan, duloxetine, Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major; Anxiety Disorders, 19/06/2015, , 17, 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, , , 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 |
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 |
Pharmacovigilance: Overview |
|
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 |
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, , 5, Authorised |
|
21/04/2022 |
Periodic safety update single assessment: Cetirizine pseudoephedrine : List of nationally authorised medicinal products - PSUSA/00000629/202108
|
|
21/04/2022 |
Referral: Lidocain/Prilocain Idetec and associated names
, lidocaine, prilocaine, Lidocaïne / Prilocaïne 5% Focus, Crème, Article 29(4) referrals, European Commission final decision, 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 of the CHMP meeting 19-22 April 2022
|
|
21/04/2022 |
Human medicines European public assessment report (EPAR): Verzenios, abemaciclib, Breast Neoplasms, 26/09/2018, , 8, Authorised |
|
20/04/2022 |
Human medicines European public assessment report (EPAR): Nubeqa, darolutamide, Prostatic Neoplasms, Castration-Resistant, 27/03/2020, , 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 - Scientific guideline |
|
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
|
|
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 |
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 - Scientific guideline |
|
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, , , 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, , 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 |
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 |
Parallel joint scientific consultation with regulators and 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 |
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 |
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11/04/2022 |
Periodic safety update single assessment: Gadopentetic acid : List of nationally authorised medicinal products - PSUSA/00001504/202108
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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 |
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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 |
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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
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11/04/2022 |
Other: European Medicines Agency data protection notice concerning the Veterinary Info Day meeting on 12-13 May 2022
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11/04/2022 |
Template or form: Innovation Task Force (ITF) briefing meeting request form
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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
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11/04/2022 |
Newsletter: CTIS newsflash - 8 April 2022
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11/04/2022 |
Newsletter: Human medicines highlights - April 2022
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11/04/2022 |
Agenda: Agenda - Enpr-EMA Coordinating Group and networks meeting
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11/04/2022 |
Human medicines European public assessment report (EPAR): Toujeo (previously Optisulin), insulin glargine, Diabetes Mellitus, 26/06/2000, 32, Authorised |
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11/04/2022 |
Agenda: Agenda of the COMP meeting 11-13 April 2022
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11/04/2022 |
Periodic safety update single assessment: Aniracetam : List of nationally authorised medicinal products : PSUSA/00010790/202108
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11/04/2022 |
Agenda: Agenda of the CAT meeting 11-13 April 2022
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11/04/2022 |
Agenda: Agenda of the CVMP meeting 11-13 April 2022
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11/04/2022 |
Herbal medicinal product: Sennae fructus, Sennae fructus, F: Assessment finalised
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11/04/2022 |
Herbal medicinal product: Rhei radix, Rhei radix, F: Assessment finalised
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11/04/2022 |
Herbal medicinal product: Aloes folii succus siccatus, Aloes folii succus siccatus, F: Assessment finalised
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11/04/2022 |
Herbal medicinal product: Frangulae cortex, Frangulae cortex, F: Assessment finalised
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11/04/2022 |
Orphan designation: Leniolisib
for the: Treatment of activated phosphoinositide 3-kinase delta syndrome, 19/10/2020, Positive |
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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 |
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11/04/2022 |
Periodic safety update single assessment: Rilmenidine : List of nationally authorised medicinal products - PSUSA/00002643/202108
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08/04/2022 |
Paediatric medicines: Overview |
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08/04/2022 |
Human medicines European public assessment report (EPAR): Abilify, aripiprazole, Schizophrenia; Bipolar Disorder, 04/06/2004, 49, Authorised |
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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)
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08/04/2022 |
Periodic safety update single assessment: Gadoteridol : List of nationally authorised medicinal products - PSUSA/00001507/202108
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08/04/2022 |
Withdrawn application: Zektayos - Hepjuvo, obeticholic acid, Date of withdrawal: 09/12/2021, Initial authorisation |
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08/04/2022 |
Report: Report on budgetary and financial management - financial year 2021
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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 |
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08/04/2022 |
News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022 |
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08/04/2022 |
Periodic safety update single assessment: Buserelin : List of nationally authorised medicinal products - PSUSA/00000462/202108
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08/04/2022 |
Report: Applications for new human medicines under evaluation by the CHMP: April 2022
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08/04/2022 |
Human medicines European public assessment report (EPAR): Nilemdo, Bempedoic acid, Hypercholesterolemia; Dyslipidemias, 01/04/2020, , 6, Authorised |
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08/04/2022 |
Report: Annual report on the use of the special contribution for orphan medicinal products - 2021
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08/04/2022 |
Human medicines European public assessment report (EPAR): Palonosetron Hospira, palonosetron hydrochloride, Nausea; Vomiting; Cancer, 08/04/2016, , 4, Withdrawn |
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08/04/2022 |
Opinion on medicine for use outside EU: Umbipro, chlorhexidine digluconate, Soft Tissue Infections, 28/04/2016, Withdrawn opinion |
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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
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07/04/2022 |
Periodic safety update single assessment: Finasteride : List of nationally authorised medicinal products - PSUSA/00001392/202108
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07/04/2022 |
Regulatory and procedural guideline: Guidance on Irish language derogation ending on 1 January 2022
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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 |
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07/04/2022 |
Orphan designation: Rimiducid
for the: Treatment of graft-versus-host disease, 30/05/2016, Withdrawn |
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07/04/2022 |
Human medicines European public assessment report (EPAR): Insulin lispro Sanofi, insulin lispro, Diabetes Mellitus, 19/07/2017,  , 7, Authorised |
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07/04/2022 |
Human medicines European public assessment report (EPAR): Febuxostat Krka, febuxostat, Hyperuricemia; Gout, 28/03/2019, , 3, Authorised |
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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 |
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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
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07/04/2022 |
Other: Mandate of the Working Group on Active Substance Master File Procedures
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07/04/2022 |
Other: European Medicines Agency’s Data Protection Notice for the Microsoft Edge
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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 |
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06/04/2022 |
Veterinary medicines European public assessment report (EPAR): Purevax RCP, attenuated feline panleucopenia virus (PLI IV), 23/02/2005, 17, Authorised |
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06/04/2022 |
Human medicines European public assessment report (EPAR): Daptomycin Hospira, daptomycin, Soft Tissue Infections; Skin Diseases, Bacterial, 22/03/2017, , 13, Authorised |
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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 |
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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
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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
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06/04/2022 |
News and press releases: ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines |
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06/04/2022 |
Periodic safety update single assessment: Tiagabine : List of nationally authorised medicinal products - PSUSA/00002942/202106
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06/04/2022 |
Orphan designation: Molgramostim
for the: Treatment of acute respiratory distress syndrome (ARDS), 27/06/2016, Positive |
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06/04/2022 |
Orphan designation: Granulocyte-macrophage colony-stimulating factor
for the: Treatment of pulmonary alveolar proteinosis, 17/07/2013, Positive |
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06/04/2022 |
Orphan designation: Ciprofloxacin
for the: Treatment of cystic fibrosis, 24/07/2009, Positive |
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06/04/2022 |
Template or form: PRIME eligibility request: applicant’s justification template
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06/04/2022 |
Human medicines European public assessment report (EPAR): Nimvastid, rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease, 11/05/2009, , 9, Authorised |
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06/04/2022 |
Minutes: Minutes of the COMP meeting on 15-17 February 2022
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06/04/2022 |
Scientific guideline: Draft ICH guideline E11A on pediatric extrapolation Step 2b
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06/04/2022 |
Good clinical practice |
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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 |
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06/04/2022 |
Herbal medicinal product: Urticae radix, Urticae radix, F: Assessment finalised
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06/04/2022 |
Herbal medicinal product: Tiliae flos, Tiliae flos, F: Assessment finalised
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06/04/2022 |
Herbal medicinal product: Rhodiolae roseae rhizoma et radix, Rhodiolae roseae rhizoma et radix, F: Assessment finalised
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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, , 12, Authorised |
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06/04/2022 |
Other: Orphan medicines figures 2000-2021
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06/04/2022 |
Human medicines European public assessment report (EPAR): Urorec, silodosin, Prostatic Hyperplasia, 29/01/2010, 18, Authorised |
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05/04/2022 |
Other: Release notes - production release version 1.6.2 April 2022 - Veterinary Medicinal Products Regulation: Union Product Database
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05/04/2022 |
Other: Example files - production release version 1.6.2 April 2022 - Veterinary Medicinal Products Regulation: Union Product Database
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05/04/2022 |
Other: Nullification ICSRs received by EudraVigilance
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05/04/2022 |
Other: Letter of support for the Global Platform Study of Novel Medicines in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma (Glo-BNHL platform)
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05/04/2022 |
Newsletter: CTIS newsflash - 1 April 2022
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05/04/2022 |
Report: PRIME: Analysis of the first 5 years' experience
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05/04/2022 |
Minutes: PDCO meeting report of opinions on paediatric investigation plans and other activities 18-21 January 2022
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05/04/2022 |
Human medicines European public assessment report (EPAR): Tresiba, insulin degludec, Diabetes Mellitus, 20/01/2013, 16, Authorised |
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05/04/2022 |
Human medicines European public assessment report (EPAR): Glivec, imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Gastrointestinal Stromal Tumors; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome, 07/11/2001, , 44, Authorised |
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05/04/2022 |
Human medicines European public assessment report (EPAR): Farydak, panobinostat lactate anhydrous, Multiple Myeloma, 28/08/2015, , 11, Authorised |
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05/04/2022 |
Veterinary medicines European public assessment report (EPAR): Improvac, Synthetic peptide analogue of GnRF conjugated to diptheria toxoid, 11/05/2009, 20, Authorised |
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05/04/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Mecasermin rinfabate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0066/2020 |
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04/04/2022 |
Veterinary medicines European public assessment report (EPAR): Porcilis PCV ID, porcine circovirus type 2 ORF2 subunit antigen, 28/08/2015, 3, Authorised |
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04/04/2022 |
Agenda: Agenda of the PRAC meeting 4-7 April 2022
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04/04/2022 |
Human medicines European public assessment report (EPAR): Teysuno, tegafur, gimeracil, oteracil, Stomach Neoplasms, 14/03/2011, 21, Authorised |
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04/04/2022 |
Other: Member states business processes and roles - CTIS Training Programme - Module 07
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04/04/2022 |
Other: Sponsors business processes and roles - CTIS Training Programme - Module 07
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04/04/2022 |
Other: Roles and permissions matrix summary - Authority workspace - CTIS Training Programme - Module 07
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04/04/2022 |
Veterinary medicines European public assessment report (EPAR): Forceris, toltrazuril, iron (III) ion, 23/04/2019, 1, Authorised |
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04/04/2022 |
Human medicines European public assessment report (EPAR): Skysona, elivaldogene autotemcel, Adrenoleukodystrophy, 16/07/2021, , Withdrawn |
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04/04/2022 |
Scientific guideline: Draft ibuprofen oral use immediate release formulations 200 – 800 mg product-specific bioequivalence guidance - Revision 1
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04/04/2022 |
Ibuprofen product-specific bioequivalence guidance |
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04/04/2022 |
Human medicines European public assessment report (EPAR): Oxervate, Recombinant human nerve growth factor, Keratitis, 06/07/2017, , , , 1, Authorised |
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04/04/2022 |
Orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA (elivaldogene autotemcel)
for the: Treatment of adrenoleukodystrophy, 06/06/2012, Withdrawn |
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04/04/2022 |
Tadalafil product-specific bioequivalence guidance |
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04/04/2022 |
Scientific guideline: Draft tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 2
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04/04/2022 |
Clinical Trials Information System (CTIS): Walk-in clinic
, Online, 16:00 - 17:00 Amsterdam time (CEST), from 04/04/2022 to 04/04/2022 |
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04/04/2022 |
Human medicines European public assessment report (EPAR): Stimufend, pegfilgrastim, Neutropenia, 28/03/2022, , , Authorised |
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04/04/2022 |
Paracetamol product-specific bioequivalence guidance |
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04/04/2022 |
Scientific guideline: Draft paracetamol oral use immediate release formulations product-specific bioequivalence guidance - Revision 1
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04/04/2022 |
Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 14-17 December 2021
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