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18/06/2021 Paediatric Committee (PDCO): 20-23 April 2021 , Virtual meeting, from 20/04/2021 to 23/04/2021 (updated)
18/06/2021 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 20-23 April 2021
18/06/2021 Minutes: Minutes of the CAT meeting 14-16 April 2021
18/06/2021 Human medicines European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), ChAdOx1-SARS-COV-2, COVID-19 virus infection, 29/01/2021, Additional monitoring, Conditional approval, 8, Authorised (updated)
18/06/2021 Veterinary medicines European public assessment report (EPAR): Pirsue, pirlimycin, 29/01/2001, 15, Authorised (updated)
18/06/2021 Management Board meeting: 17 June 2021 , European Medicines Agency, Amsterdam, the Netherlands, from 17/06/2021 to 17/06/2021 (updated)
18/06/2021 Other: Management Board meeting dates 2022-2023
18/06/2021 Report: Outcome of written procedures finalised during the period from 13 February 2021 to 25 May 2021
18/06/2021 Other: Questions and answers on labelling flexibilities for COVID-19 vaccines (updated)
18/06/2021 News and press releases: Highlights of Management Board: June 2021 meeting
18/06/2021 Scientific guideline: EudraVigilance access policy for medicines for veterinary use - Revision 2
18/06/2021 Regulatory and procedural guideline: Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 28 January 2022
18/06/2021 EudraVigilance access policy for medicines for veterinary use (updated)
18/06/2021 Human medicines European public assessment report (EPAR): 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, Additional monitoring, Conditional approval, 7, Authorised (updated)
18/06/2021 EPAR - Risk-management-plan summary: COVID-19 Vaccine Moderna: EPAR - Risk-management-plan (updated)
18/06/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Comirnaty: 18 June 2021
18/06/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for COVID-19 Vaccine Moderna: 18 June 2021
18/06/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 18 June 2021
18/06/2021 Human medicines European public assessment report (EPAR): COVID-19 Vaccine Janssen, adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection, 11/03/2021, Additional monitoring, Conditional approval, 2, Authorised (updated)
18/06/2021 Human medicines European public assessment report (EPAR): Comirnaty, Single-stranded, 5’-capped messenger RNA 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, 21/12/2020, Additional monitoring, Conditional approval, 8, Authorised (updated)
18/06/2021 COVID-19: latest updates (updated)
18/06/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 18 June 2021
18/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Adeno-associated viral vector serotype 8 containing the human MTM1 gene (resamirigene bilparvovec), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0309/2020
18/06/2021 Summary of opinion: Strangvac, Streptococcus equi vaccine (recombinant proteins), 17/06/2021, Positive
18/06/2021 News and press releases: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 15-17 June 2021
18/06/2021 Summary of opinion: Fatrovax RHD, Rabbit haemorrhagic disease vaccine (inactivated, recombinant), 17/06/2021, Positive
18/06/2021 Summary of opinion: Tessie, tasipimidine, 17/06/2021, Positive
18/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): darunavir,ritonavir, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0308/2020
18/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Rilzabrutinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0306/2020
18/06/2021 Agenda: Agenda for the 112th meeting of the Management Board: 17 June 2021 (updated)
18/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Marstacimab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0292/2020
18/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Fasinumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0307/2020
18/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Alpelisib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0329/2020
18/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Elafibranor, W: decision granting a waiver in all age groups for all conditions or indications, P/0295/2020
18/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Tremfya, guselkumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0293/2020
18/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Entresto, sacubitril,valsartan, W: decision granting a waiver in all age groups for all conditions or indications, P/0315/2020
18/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0304/2020
18/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Fasenra, benralizumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0314/2020
18/06/2021 Human medicines European public assessment report (EPAR): Nimenrix, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal, 20/04/2012, 33, Authorised (updated)
18/06/2021 Regulatory and procedural guideline: Draft guideline on computerised systems and electronic data in clinical trials
18/06/2021 Veterinary medicines European public assessment report (EPAR): Credelio, lotilaner, 23/04/2017, 5, Authorised (updated)
18/06/2021 Human medicines European public assessment report (EPAR): Opsumit, Macitentan, Hypertension, Pulmonary, 20/12/2013, Orphan, 18, Authorised (updated)
18/06/2021 Minutes: Minutes of the CAT meeting 17-18 March 2021
18/06/2021 Periodic safety update single assessment: 13C-methacetin : List of nationally authorised medicinal products - PSUSA/00010846/202010
18/06/2021 EMA regular press briefing on COVID-19 , Virtual meeting, from 17/06/2021 to 17/06/2021 (updated)
18/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Tominersen, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0264/2020
17/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Icosasodium{26-[(2-acetamido-2-deoxy-β-D-galactopyranosyl)oxy]-14,14-bis{[(3-{6-[(2-acetamido-2-deoxy-β-D-galactopyranosyl)oxy]hexyl}amino)-3-oxopropoxy)]methyl}-8,12,19-trioxo-16-oxa-7,13,20-triazahexacosyl}2′-O-(2-methoxyethyl..., W: decision granting a waiver in all age groups for all conditions or indications, P/0245/2020
17/06/2021 Human medicines European public assessment report (EPAR): Parsabiv, etelcalcetide hydrochloride, Hyperparathyroidism, Secondary, 11/11/2016, Additional monitoring, 8, Authorised (updated)
17/06/2021 Human medicines European public assessment report (EPAR): Palynziq, Pegvaliase, Phenylketonurias, 03/05/2019, Orphan, Additional monitoring, 2, Authorised (updated)
17/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Ravagalimab, W: decision granting a waiver in all age groups for all conditions or indications, P/0249/2020
17/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): sutimlimab, W: decision granting a waiver in all age groups for all conditions or indications, P/0265/2020
17/06/2021 Human medicines European public assessment report (EPAR): Cufence, trientine dihydrochloride, Hepatolenticular Degeneration, 25/07/2019, 3, Authorised (updated)
17/06/2021 Periodic safety update single assessment: Etifoxine : List of nationally authorised medicinal products - PSUSA/00001321/202010
17/06/2021 Human medicines European public assessment report (EPAR): Lynparza, Olaparib, Ovarian Neoplasms, 16/12/2014, 14, Authorised (updated)
17/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin,Ezetimibe, W: decision granting a waiver in all age groups for all conditions or indications, P/0251/2020
17/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Epidyolex, Cannabidiol, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0095/2020
17/06/2021 Business hours and holidays (updated)
17/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Tixagevimab (AZD8895), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0236/2021
17/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Bamlanivimab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0221/2021
17/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Cilgavimab (AZD1061), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0235/2021
17/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Regdanvimab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0234/2021
17/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Etesevimab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0214/2021
17/06/2021 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
17/06/2021 Periodic safety update single assessment: Epinephrine / lidocaine : List of nationally authorised medicinal products - PSUSA/00001233/202009
17/06/2021 Human medicines European public assessment report (EPAR): RoActemra, tocilizumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, 15/01/2009, 33, Authorised (updated)
17/06/2021 Human medicines European public assessment report (EPAR): Biktarvy, bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections, 21/06/2018, Additional monitoring, 12, Authorised (updated)
17/06/2021 Human medicines European public assessment report (EPAR): Zercepac, trastuzumab, Breast Neoplasms, Stomach Neoplasms, 27/07/2020, Additional monitoring, Biosimilar, 4, Authorised (updated)
17/06/2021 Human medicines European public assessment report (EPAR): Yuflyma, adalimumab, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Psoriasis, Arthritis, Psoriatic, Colitis, Ulcerative, Crohn Disease, Arthritis, Juvenile Rheumatoid, Hidradenitis Suppurativa, Uveitis, 11/02/2021, Biosimilar, 3, Authorised (updated)
17/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Opdivo, nivolumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0280/2020
17/06/2021 Human medicines European public assessment report (EPAR): Ofev, nintedanib, Idiopathic Pulmonary Fibrosis, 14/01/2015, Accelerated assessment, 19, Authorised (updated)
17/06/2021 Report: Medicinal products for human use: monthly figures - May 2021
16/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Nerlynx, neratinib, W: decision granting a waiver in all age groups for all conditions or indications, P/0246/2020
16/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Bisoprolol fumarate,Trimetazidine (dihydrochloride), W: decision granting a waiver in all age groups for all conditions or indications, P/0261/2020
16/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): human fibrinogen, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0260/2020
16/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Humanised Antibody Targeting the Inducible T cell Co-Stimulatory receptor, W: decision granting a waiver in all age groups for all conditions or indications, P/0259/2020
16/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Ondansetron (hydrochloride), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0248/2020
16/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Sitagliptin (hydrochloride monohydrate),metformin hydrochloride, W: decision granting a waiver in all age groups for all conditions or indications, P/0247/2020
16/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Insulin 287, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0263/2020
16/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human IgGlA monoclonal Fab antibody, RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s), P/0262/2020
16/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Pegzilarginase, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0252/2020
16/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Lonapegsomatropin, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0275/2020
16/06/2021 Veterinary medicines European public assessment report (EPAR): Emdocam, meloxicam, 18/08/2011, Generic, 8, Authorised (updated)
16/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Sparsentan, PM: decision on the application for modification of an agreed PIP, P/0021/2021
16/06/2021 Periodic safety update single assessment: Ketotifen : List of nationally authorised medicines - PSUSA/00001813/202010
16/06/2021 Template or form: Translations required with the submission of an application for orphan medicinal product designation (updated)
16/06/2021 Periodic safety update single assessment: Minoxidil : List of nationally authorised medicines - PSUSA-00002067-202010
16/06/2021 Veterinary medicines European public assessment report (EPAR): Reconcile, fluoxetine, 08/07/2008, 14, Authorised (updated)
16/06/2021 Human medicines European public assessment report (EPAR): Zykadia, ceritinib, Carcinoma, Non-Small-Cell Lung, 06/05/2015, 15, Authorised (updated)
16/06/2021 Periodic safety update single assessment: Clevidipine : List of nationally authorised medicines - PSUSA/00010288/202011
16/06/2021 Periodic safety update single assessment: Bisoprolol / perindopril : List of nationally authorised medicines - PSUSA/00010462/202010
16/06/2021 Periodic safety update single assessment: Triamcinolone : List of nationally authorised medicines - PSUSA/00010137/202009
16/06/2021 Periodic safety update single assessment: Salmeterol : List of nationally authorised medicines - PSUSA/00002681/202010
16/06/2021 Human medicines European public assessment report (EPAR): Nyvepria, pegfilgrastim, Neutropenia, 18/11/2020, Additional monitoring, Biosimilar, 2, Authorised (updated)
16/06/2021 Agenda: Agenda - CAT agenda of the 16-18 June 2021 meeting
16/06/2021 Human medicines European public assessment report (EPAR): Alkindi, hydrocortisone, Adrenal Insufficiency, 09/02/2018, 6, Authorised (updated)
16/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Tecovirimat (monohydrate), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0274/2020
16/06/2021 Website outages and upgrades (updated)
16/06/2021 Periodic safety update single assessment: Desogestrel / ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00000967/202009
16/06/2021 Periodic safety update single assessment: Acitretin : List of nationally authorised medicinal products - PSUSA/00000051/202010
16/06/2021 Regulatory and procedural guideline: Procedural advice for orphan medicinal product designation: Guidance for sponsors (updated)
16/06/2021 Template or form: Template - Translations required with the submission of an application for transfer of orphan medicinal product designation (updated)
16/06/2021 Periodic safety update single assessment: Adapalene / benzoyl peroxide : List of nationally authorised medicinal products - PSUSA/00000059/202009
16/06/2021 News and press releases: IT systems temporarily unavailable from 18 to 20 June 2021
16/06/2021 Human medicines European public assessment report (EPAR): Lumeblue (previously known as Methylthioninium chloride Cosmo), methylthioninium chloride, Colorectal Neoplasms, Colonoscopy, 19/08/2020, 2, Authorised (updated)
16/06/2021 Human medicines European public assessment report (EPAR): Vimizim, recombinant human n-acetylgalactosamine-6-sulfatase, Mucopolysaccharidosis IV, 27/04/2014, Orphan, Additional monitoring, 12, Authorised (updated)
16/06/2021 Periodic safety update single assessment: Beractant : List of nationally authorised medicines - PSUSA/00000384/202010
15/06/2021 Financial management and budgetary reporting (updated)
15/06/2021 Report: Report on budgetary and financial management: financial year 2018
15/06/2021 Report: Report on budgetary and financial management: financial year 2019
15/06/2021 Report: Report on budgetary and financial management: financial year 2020
15/06/2021 Human medicines European public assessment report (EPAR): Riximyo, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Microscopic Polyangiitis, Wegener Granulomatosis, 15/06/2017, Additional monitoring, Biosimilar, 5, Authorised (updated)
15/06/2021 Periodic safety update single assessment: Amlodipine / atorvastatin / perindopril - List of nationally authorised medicinal products - PSUSA/00010431/202010
15/06/2021 About this website
15/06/2021 Human medicines European public assessment report (EPAR): Blincyto, blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 23/11/2015, Orphan, Additional monitoring, 13, Authorised (updated)
15/06/2021 Veterinary medicines European public assessment report (EPAR): Felisecto Plus, selamectin, sarolaner, 26/04/2019, 2, Authorised (updated)
15/06/2021 Human medicines European public assessment report (EPAR): Diacomit, stiripentol, Myoclonic Epilepsy, Juvenile, 03/01/2007, 11/02/2009, 17, Authorised (updated)
15/06/2021 COVID-19 treatments: research and development (updated)
15/06/2021 COVID-19 vaccines: research and development (updated)
15/06/2021 Human medicines European public assessment report (EPAR): Rixathon, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell, Wegener Granulomatosis, Microscopic Polyangiitis, Pemphigus, 15/06/2017, Additional monitoring, Biosimilar, 4, Authorised (updated)
15/06/2021 Human medicines European public assessment report (EPAR): Tysabri, natalizumab, Multiple Sclerosis, 27/06/2006, 35, Authorised (updated)
15/06/2021 Human medicines European public assessment report (EPAR): Aimovig, erenumab, Migraine Disorders, 26/07/2018, Additional monitoring, 6, Authorised (updated)
15/06/2021 Other: Records of data processing activity for user research for the design of the restricted area of the Union Product Database
15/06/2021 Other: European Medicines Agency’s privacy statement for the usability testing of the restricted area of the Union Product Database
15/06/2021 Other: Consideration on core requirements for RMPs of COVID-19 vaccines (updated)
15/06/2021 Periodic safety update single assessment: Rubidium chloride RB-82 - List of nationally authorised medicinal products - PSUSA-00010806-202010
15/06/2021 Agenda: Agenda - CVMP agenda of the 15-17 June 2021 meeting
15/06/2021 Periodic safety update single assessment: Bivalrudin : List of nationally authorised medicinal products - PSUSA/00000421/202009
15/06/2021 Herbal medicinal product: Tribuli terrestris herba, Tribuli terrestris herba, C: ongoing call for scientific data
14/06/2021 Other: Declaration of interest: Irene Rager (updated)
14/06/2021 News and press releases: Annual report 2020 published
14/06/2021 Annual Report: Annexes - 2020 annual report of the European Medicines Agency
14/06/2021 Annual reports and work programmes (updated)
14/06/2021 Annual Report: 2020 annual report of the European Medicines Agency
14/06/2021 Annual Report: Annex 10 - 2020 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indication
14/06/2021 Orphan designation: hydrocortisone for the: Treatment of congenital adrenal hyperplasia, 27/07/2005, Positive (updated)
14/06/2021 Human medicines European public assessment report (EPAR): Efmody, hydrocortisone, Adrenal Hyperplasia, Congenital, 27/05/2021, Authorised (updated)
14/06/2021 Agenda: Programme and registration form - Risk management information day 2021 (updated)
14/06/2021 Risk management information day 2021 , Virtual meeting, from 15/06/2021 to 15/06/2021 (updated)
14/06/2021 Deferasirox product-specific bioequivalence guidance (updated)
14/06/2021 Scientific guideline: Deferasirox, dispersible tablets (125 mg, 250 mg and 500 mg), film-coated tablets (90 mg, 180 mg, and 360 mg), and granules (90 mg, 180 mg and 360 mg) product-specific bioequivalence guidance
14/06/2021 Overview of comments: Overview of comments received on 'Deferasirox, dispersible tablets (125 mg, 250 mg and 500 mg), film-coated tablets (90 mg, 180 mg, and 360 mg), and granules (90 mg, 180 mg and 360 mg) product-specific bioequivalence guidance' (EMA/CHMP/472383/2020)
11/06/2021 Referral: Zynteglo , betibeglogene autotemcel, Article 20 procedures, Under evaluation, 11/06/2021 (updated)
11/06/2021 Minutes: Minutes of the COMP meeting 13-15 April 2021
11/06/2021 Committee for Orphan Medicinal Products (COMP): 13-15 April 2021 , European Medicines Agency, Amsterdam, the Netherlands, from 13/04/2021 to 15/04/2021 (updated)
11/06/2021 News and press releases: COVID-19 Vaccine Janssen: authorities in EU take steps to safeguard vaccine quality
11/06/2021 Article 5(3) opinions (updated)
11/06/2021 Referrals document: Sotrovimab (also known as VIR-7831 and GSK4182136) - COVID19 - Article-5(3) procedure: Assessment report
11/06/2021 News and press releases: Additional manufacturing capacity for Moderna’s COVID-19 vaccine
11/06/2021 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2021
11/06/2021 News and press releases: COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis
11/06/2021 News and press releases: Vaxzevria: EMA advises against use in people with history of capillary leak syndrome
11/06/2021 Periodic safety update single assessment: Lidocaine : List of nationally authorised medicinal products - PSUSA/00001861/202009
11/06/2021 Opinions and letters of support on the qualification of novel methodologies for medicine development (updated)
11/06/2021 Other: Letter of support for Mobilise-D digital mobility outcomes as monitoring biomarkers - Follow-up
11/06/2021 Human medicines European public assessment report (EPAR): Neparvis, sacubitril, valsartan, Heart Failure, 26/05/2016, Additional monitoring, 12, Authorised (updated)
11/06/2021 Human medicines European public assessment report (EPAR): Entresto, sacubitril, valsartan, Heart Failure, 19/11/2015, 13, Authorised (updated)
11/06/2021 Other: Safety Working Party recommendations on the duration of contraception following the end of treatment with a genotoxic drug (updated)
11/06/2021 Human medicines European public assessment report (EPAR): Skyrizi, Risankizumab, Psoriasis, 26/04/2019, Additional monitoring, 5, Authorised (updated)
11/06/2021 Veterinary Big Data stakeholder forum , Virtual event, from 01/06/2021 to 02/06/2021 (updated)
11/06/2021 International Coalition of Medicines Regulatory Authorities (ICMRA) (updated)
11/06/2021 Human medicines European public assessment report (EPAR): Zejula, Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms, 16/11/2017, Orphan, Additional monitoring, 13, Authorised (updated)
11/06/2021 News and press releases: International regulators and WHO address need to boost COVID-19 vaccine confidence
11/06/2021 Agenda: Agenda - COMP agenda of the 15-17 June 2021 meeting
11/06/2021 Orphan designation: Adeno-associated viral vector serotype 2/2 containing a gene encoding the channelrhodopsin-2 protein for the: Treatment of retinitis pigmentosa, 14/10/2016, Withdrawn (updated)
11/06/2021 Veterinary medicines European public assessment report (EPAR): Tulissin, tulathromycin, 24/04/2020, Generic, 2, Authorised (updated)
10/06/2021 Human medicines European public assessment report (EPAR): DaTSCAN, ioflupane (123l), Tomography, Emission-Computed, Single-Photon, Lewy Body Disease, Parkinson Disease, Alzheimer Disease, 27/07/2000, 23, Authorised (updated)
10/06/2021 Human medicines European public assessment report (EPAR): Xerava, eravacycline, Infection, Bacterial Infections, 20/09/2018, Additional monitoring, 2, Authorised (updated)
10/06/2021 Orphan designation: Entinostat for the: Treatment of Hodgkin's lymphoma, 10/06/2010, Positive (updated)
10/06/2021 Orphan designation: 2-Chloro-N6-(3-iodobenzyl)adenosine-5'-N-methyluronamide (namodenoson) for the: Treatment of hepatocellular carcinoma, 09/10/2015, Positive (updated)
10/06/2021 Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm, clopidogrel (as hydrogen sulfate), Myocardial Infarction, Acute Coronary Syndrome, Peripheral Vascular Diseases, Stroke, 18/02/2015, Generic, 11, Authorised (updated)
10/06/2021 Human medicines European public assessment report (EPAR): Targretin, bexarotene, Lymphoma, T-Cell, Cutaneous, 29/03/2001, 22, Authorised (updated)
10/06/2021 Human medicines European public assessment report (EPAR): Cometriq, cabozantinib, Thyroid Neoplasms, 21/03/2014, Orphan, Additional monitoring, Conditional approval, 22, Authorised (updated)
10/06/2021 Human medicines European public assessment report (EPAR): Zalasta, olanzapine, Schizophrenia, Bipolar Disorder, 27/09/2007, Generic, 18, Authorised (updated)
10/06/2021 Human medicines European public assessment report (EPAR): Erelzi, etanercept, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, Spondylitis, Ankylosing, 23/06/2017, Additional monitoring, Biosimilar, 9, Authorised (updated)
10/06/2021 Human medicines European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate), clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke, 27/07/2009, Generic, 17, Authorised (updated)
10/06/2021 Human medicines European public assessment report (EPAR): Qtern, Saxagliptin, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, 15/07/2016, 7, Authorised (updated)
10/06/2021 Direct healthcare professional communication (DHPC): Venclyxto - (venetoclax) film coated tablets: Updated recommendations on tumour lysis syndrome (TLS) in CLL patients, Active substance: Venetoclax, DHPC type: Type II variation, Last updated: 10/06/2021
10/06/2021 Orphan designation: Pomalidomide for the: Treatment of multiple myeloma, 08/10/2009, Positive (updated)
10/06/2021 Human medicines European public assessment report (EPAR): Saxenda, liraglutide, Obesity, Overweight, 23/03/2015, 10, Authorised (updated)
10/06/2021 Human medicines European public assessment report (EPAR): Odefsey, emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide, HIV Infections, 21/06/2016, 18, Authorised (updated)
10/06/2021 Report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: April 2021
09/06/2021 Human medicines European public assessment report (EPAR): DuoResp Spiromax, budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Asthma, 28/04/2014, 11, Authorised (updated)
09/06/2021 Frequently asked questions about parallel distribution (updated)
09/06/2021 Human medicines European public assessment report (EPAR): BiResp Spiromax, budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Asthma, 28/04/2014, 11, Authorised (updated)
09/06/2021 Regulatory and procedural guideline: Checklist for annual updates for parallel distribution: guidance for industry (updated)
09/06/2021 Other: Frequently asked questions about parallel distribution
09/06/2021 Regulatory and procedural guideline: Checklist for initial notifications for parallel distribution: guidance for industry (updated)
09/06/2021 Human medicines European public assessment report (EPAR): Benlysta, belimumab, Lupus Erythematosus, Systemic, 13/07/2011, Additional monitoring, 26, Authorised (updated)
09/06/2021 Human medicines European public assessment report (EPAR): Zoely, Nomegestrol acetate, estradiol, Contraception, 26/07/2011, Additional monitoring, 20, Authorised (updated)
09/06/2021 Orphan review: Recommendation for maintenance of orphan designation at the time of addition of new indications to the marketing authorisation: Carbaglu (carglumic acid) for the treatment of isovaleric acidaemia, methylmalonic acidaemia... (updated)
09/06/2021 Orphan designation: carglumic acid for the: Treatment of methylmalonic acidaemia, 07/11/2008, Expired (updated)
09/06/2021 Orphan designation: carglumic acid for the: Treatment of propionic acidaemia, 07/11/2008, Expired (updated)
09/06/2021 Orphan designation: carglumic acid for the: Treatment of isovaleric acidaemia, 07/11/2008, Expired (updated)
09/06/2021 Human medicines European public assessment report (EPAR): Carbaglu, carglumic acid, Amino Acid Metabolism, Inborn Errors, Propionic Acidemia, 24/01/2003, 18, Authorised (updated)
09/06/2021 Human medicines European public assessment report (EPAR): Hulio, adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic, 17/09/2018, Additional monitoring, Biosimilar, 6, Authorised (updated)
09/06/2021 Referral: Varilrix , live attenuated varicella virus (OKA strain), Article 30 referrals, European Commission final decision, 25/02/2021, 21/04/2021, 09/06/2021 (updated)
09/06/2021 Orphan designation: Ganaxolone for the: Treatment of CDKL5 deficiency disorder, 13/11/2019, Positive (updated)
09/06/2021 Human medicines European public assessment report (EPAR): Talzenna, talazoparib, Breast Neoplasms, 20/06/2019, Additional monitoring, 4, Authorised (updated)
09/06/2021 Human medicines European public assessment report (EPAR): Voriconazole Hikma (previously Voriconazole Hospira), voriconazole, Bacterial Infections and Mycoses, Aspergillosis, Candidiasis, 27/05/2015, Generic, 9, Authorised (updated)
09/06/2021 Human medicines European public assessment report (EPAR): Elonva, corifollitropin alfa, Reproductive Techniques, Assisted, Ovulation Induction, 25/01/2010, 19, Authorised (updated)
09/06/2021 Human medicines European public assessment report (EPAR): Prometax, rivastigmine, Alzheimer Disease, Parkinson Disease, Dementia, 03/12/1998, 40, Authorised (updated)
09/06/2021 Human medicines European public assessment report (EPAR): Nepexto, etanercept, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Spondylarthropathies, Spondylitis, Ankylosing, Psoriasis, 20/05/2020, Additional monitoring, Biosimilar, 4, Authorised (updated)
09/06/2021 Human medicines European public assessment report (EPAR): Cresemba, isavuconazole, Aspergillosis, 15/10/2015, Orphan, 11, Authorised (updated)
09/06/2021 Human medicines European public assessment report (EPAR): Inrebic, fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders, Primary Myelofibrosis, 08/02/2021, Orphan, Additional monitoring, Authorised (updated)
09/06/2021 Supply shortage: Shortage of Vfend (voriconazole) supply shortage (updated)
09/06/2021 Other: Membership list - HMA / EMA joint Big Data Steering Group (updated)
09/06/2021 Human medicines European public assessment report (EPAR): Ibrance, palbociclib, Breast Neoplasms, 09/11/2016, Additional monitoring, 12, Authorised (updated)
08/06/2021 Human medicines European public assessment report (EPAR): Xeljanz, tofacitinib citrate, Arthritis, Rheumatoid, 21/03/2017, 25/04/2013, Patient safety, Additional monitoring, 18, Authorised (updated)
08/06/2021 Veterinary medicines European public assessment report (EPAR): Letifend, Recombinant protein Q from Leishmania infantum MON-1, 20/04/2016, 10, Authorised (updated)
08/06/2021 Orphan designation: Ivosidenib for the: Treatment of biliary tract cancer, 21/03/2018, Positive (updated)
08/06/2021 Orphan designation: Ivosidenib for the: Treatment of acute myeloid leukaemia, 12/12/2016, Positive (updated)
08/06/2021 Human medicines European public assessment report (EPAR): Zebinix, eslicarbazepine acetate, Epilepsy, 21/04/2009, 28, Authorised (updated)
08/06/2021 Orphan designation: Poly(oxy-1,2-ethanediyl),.alpha.-hydro-.omega.-hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-.alpha.-aspartyl-L-tryptophylglycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxy-L-lysinamide cyclic (2.fwdarw.12)-(disulfide); where two identical synthetic peptide domains are covalently linked at the ends of the polyethylene glycol chain for the: Treatment of paroxysmal nocturnal haemoglobinuria, 22/05/2017, Positive (updated)
08/06/2021 News and press releases: EMA evaluating the use of COVID-19 Vaccine Moderna in young people aged 12 to 17
08/06/2021 Orphan designation: 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]-1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]-2-propen-1-one (futibatinib) for the: Treatment of biliary tract cancer, 01/04/2019, Positive (updated)
08/06/2021 Human medicines European public assessment report (EPAR): Nodetrip (previously Xeristar), duloxetine, Anxiety Disorders, Depressive Disorder, Major, Diabetic Neuropathies, 17/12/2004, 32, Authorised (updated)
08/06/2021 Other: Timetable: Type II variation and worksharing application alternative monthly assessment (updated)
07/06/2021 European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint virtual meeting , Virtual meeting, from 01/06/2021 to 02/06/2021 (updated)
07/06/2021 Agenda: Agenda - ePI information workshop on 5 July
07/06/2021 Agenda: Agenda - ePI exploratory workshop on 6, 7 and 8 July
07/06/2021 ePI information workshop and exploratory workshop , Virtual event, from 05/07/2021 to 08/07/2021
07/06/2021 Veterinary medicines European public assessment report (EPAR): Hydrocortisone aceponate Ecuphar (previously Cortacare) , hydrocortisone aceponate, 27/08/2018, 1, Authorised (updated)
07/06/2021 Regulatory and procedural guideline: Draft EU Common Standard for electronic product information for human medicines (ePI)
07/06/2021 Report: Applications for new human medicines under evaluation by the CHMP: June 2021
07/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Elafibranor, PM: decision on the application for modification of an agreed PIP, P/0139/2020 (updated)
07/06/2021 Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS , Virtual meeting, from 29/07/2021 to 29/07/2021 (updated)
07/06/2021 Opinion/decision on a Paediatric investigation plan (PIP): Alpha tocotrienol quinone, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0174/2013 (updated)
07/06/2021 Agenda: Agenda - PRAC draft agenda of meeting 7-10 June 2021
07/06/2021 Template or form: Signal assessment report - template (updated)
07/06/2021 Human medicines European public assessment report (EPAR): Ilaris, Canakinumab, Cryopyrin-Associated Periodic Syndromes, Arthritis, Juvenile Rheumatoid, Arthritis, Gouty, 23/10/2009, 25, Authorised (updated)
07/06/2021 Human medicines European public assessment report (EPAR): Exelon, rivastigmine, Dementia, Alzheimer Disease, Parkinson Disease, 11/05/1998, 41, Authorised (updated)
07/06/2021 Human medicines European public assessment report (EPAR): Keytruda, Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Urologic Neoplasms, Squamous Cell Carcinoma of Head and Neck, 17/07/2015, Additional monitoring, 35, Authorised (updated)
07/06/2021 Human medicines European public assessment report (EPAR): Ketoconazole HRA, Ketoconazole, Cushing Syndrome, 18/11/2014, Orphan, Accelerated assessment, Additional monitoring, 10, Authorised (updated)
07/06/2021 Human medicines European public assessment report (EPAR): Constella, linaclotide, Irritable Bowel Syndrome, 26/11/2012, 21, Authorised (updated)
07/06/2021 Human medicines European public assessment report (EPAR): Skilarence, dimethyl fumarate, Psoriasis, 23/06/2017, 9, Authorised (updated)
07/06/2021 News and press releases: EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome
07/06/2021 Herbal medicinal product: Species sedativae, Combination: Species sedativae, F: Assessment finalised (updated)
07/06/2021 Orphan designation: Selinexor for the: Treatment of plasma cell myeloma, 19/11/2014, Positive (updated)
07/06/2021 Human medicines European public assessment report (EPAR): Nexpovio, Selinexor, Multiple Myeloma, 26/03/2021, Additional monitoring, Conditional approval, Authorised (updated)
04/06/2021 Human medicines European public assessment report (EPAR): Capecitabine Accord, capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Patient safety, Generic, 14, Authorised (updated)
04/06/2021 Human medicines European public assessment report (EPAR): Dificlir, fidaxomicin, Clostridium Infections, 05/12/2011, 15, Authorised (updated)
04/06/2021 Human medicines European public assessment report (EPAR): Dacogen, Decitabine, Leukemia, Myeloid, 20/09/2012, Orphan, 15, Authorised (updated)
04/06/2021 Human medicines European public assessment report (EPAR): Velcade, bortezomib, Multiple Myeloma, 26/04/2004, 45, Authorised (updated)
04/06/2021 Human medicines European public assessment report (EPAR): Nulojix, belatacept, Graft Rejection, Kidney Transplantation, 17/06/2011, 16, Authorised (updated)
04/06/2021 Plasma master file certificates (updated)
04/06/2021 Human medicines European public assessment report (EPAR): Quofenix, delafloxacin meglumine, Skin Diseases, Bacterial, 16/12/2019, Additional monitoring, 3, Authorised (updated)
04/06/2021 Availability of medicines (updated)
04/06/2021 EudraVigilance Veterinary (updated)
04/06/2021 Regulatory and procedural guideline: EU VICH adverse event report implementation guide
04/06/2021 Other: Annex 1 - Field Level Specification