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22/12/2021 News and press releases: Emer Cooke’s end-of-year message
22/12/2021 Human medicines European public assessment report (EPAR): Peyona (previously Nymusa), Caffeine citrate, Apnea, 02/07/2009, 13, Authorised
22/12/2021 Human medicines European public assessment report (EPAR): Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto), lenalidomide hydrochloride monohydrate, Multiple Myeloma; Myelodysplastic Syndromes; Lymphoma, Follicular; Lymphoma, Mantle-Cell, 11/02/2021, Generic, 3, Authorised
21/12/2021 Human medicines European public assessment report (EPAR): Docetaxel Accord, docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms, 22/05/2012, Generic, 15, Authorised
21/12/2021 Human medicines European public assessment report (EPAR): Darunavir Krka d.d., darunavir, HIV Infections, 18/01/2018, Generic, 8, Authorised
21/12/2021 First European Medicines Agency and Nuclear Medicines Europe bilateral meeting , Online, 13:30-15:30 (CEST), from 23/09/2021 to 23/09/2021
21/12/2021 Report: Report - European Medicines Agency-Nuclear Medicines Europe meeting
21/12/2021 Human medicines European public assessment report (EPAR): Yentreve, duloxetine hydrochloride, Urinary Incontinence, Stress, 11/08/2004, 28, Authorised
21/12/2021 Human medicines European public assessment report (EPAR): Duloxetine Lilly, duloxetine, Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major, 08/12/2014, 9, Authorised
21/12/2021 Human medicines European public assessment report (EPAR): Cymbalta, duloxetine, Anxiety Disorders; Diabetic Neuropathies; Depressive Disorder, Major, 17/12/2004, 31, Authorised
21/12/2021 Other: Note on European Medicines Agency’s involvement in HORIZON-HLTH-2022-TOOL-11-02: New methods for the effective use of real-world data and/or synthetic data in regulatory decision-making and/or in health technology assessment
21/12/2021 Other: Extension of reserve lists for external selection procedures: Contract Agent reserve list
21/12/2021 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 13-16 December 2021
21/12/2021 Other: Extension of reserve lists for external selection procedures: Temporary Agent reserve lists
21/12/2021 Orphan designation: Sirolimus for the: Treatment of perivascular epithelioid cell tumours, 19/07/2021, Positive
20/12/2021 EPAR - Assessment report on maintenance of orphan designation - Initial authorisation: Minjuvi : Orphan maintenance assessment report (initial authorisation)
20/12/2021 Veterinary medicines European public assessment report (EPAR): Stronghold Plus, selamectin, sarolaner, 08/02/2017, 4, Authorised
20/12/2021 Veterinary medicines European public assessment report (EPAR): Bovilis Blue-8, bluetongue virus vaccine, serotype 8 (inactivated), 21/11/2017, 4, Authorised
20/12/2021 Report: Report - EU Big Data Stakeholder Forum 2021
20/12/2021 News and press releases: EMA recommends Nuvaxovid for authorisation in the EU
20/12/2021 Newsletter: Enpr-EMA newsletter 2021
20/12/2021 Minutes: Minutes of the PRAC meeting 8-11 February 2021
20/12/2021 Direct healthcare professional communication (DHPC): Briviact® (In Italy: Nubriveo®) (brivaracetam 10Mg/ml) Oral solution: Bottles with narrow neck diameter, Active substance: Brivaracetam, DHPC type: Quality defect, Last updated: 20/12/2021
20/12/2021 Minutes: Minutes of the CHMP meeting 8-11 November 2021
20/12/2021 Agenda: Agenda - DADI webinar - Introducing DADI: The digital application dataset integration network project to replace electronic application forms
20/12/2021 Management Board meeting: 15-16 December 2021 , European Medicines Agency, Amsterdam, the Netherlands, from 15/12/2021 to 16/12/2021
20/12/2021 Other: Summary of transfers of appropriations in budget 2021 - Management Board meeting of 15-16 December 2021
20/12/2021 Report: Outcome of written procedures finalised during the period from 14 September 2021 to 24 November 2021
20/12/2021 Agenda: Agenda for the 114th meeting of the Management Board
20/12/2021 Regulatory and procedural guideline: Draft guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics
20/12/2021 News and press releases: EMA working on COVID-19 over holiday period
17/12/2021 News and press releases: EMA Management Board: highlights of December 2021 meeting
17/12/2021 Other: European Medicines Regulatory Network Data Standardisation Strategy
17/12/2021 Human medicines European public assessment report (EPAR): Corlentor, ivabradine hydrochloride, Angina Pectoris; Heart Failure, 25/10/2005, 26, Authorised
17/12/2021 Human medicines European public assessment report (EPAR): Procoralan, ivabradine hydrochloride, Angina Pectoris; Heart Failure, 25/10/2005, 22, Authorised
17/12/2021 Withdrawn application: Livmarli, maralixibat, Date of withdrawal: 23/08/2021, Initial authorisation
17/12/2021 Human medicines European public assessment report (EPAR): Amgevita, adalimumab, Arthritis, Psoriatic; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Psoriasis; Crohn Disease; Arthritis, Rheumatoid, 21/03/2017, Biosimilar, 10, Authorised
17/12/2021 Human medicines European public assessment report (EPAR): Lenalidomide Krka d.d., lenalidomide hydrochloride hydrate, Multiple Myeloma; Lymphoma, Follicular; Myelodysplastic Syndromes, 11/02/2021, Generic, 2, Authorised
17/12/2021 Human medicines European public assessment report (EPAR): Repaglinide Teva, repaglinide, Diabetes Mellitus, Type 2, 28/06/2009, Generic, 9, Authorised
17/12/2021 Second Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry , Online, from 08/12/2021 to 08/12/2021
17/12/2021 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021
17/12/2021 News and press releases: New treatment for sickle cell disease
17/12/2021 Human medicines European public assessment report (EPAR): Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka), lenalidomide hydrochloride monohydrate, Multiple Myeloma; Lymphoma, Follicular, 11/02/2021, Generic, 3, Authorised
17/12/2021 Other: Checklist of required fields per application type - CTIS Training Programme - Module 10
17/12/2021 Scientific guideline: Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
17/12/2021 Template or form: Appendix III b – Information to be submitted with a notification of a serious breach - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
17/12/2021 Other: Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2021
17/12/2021 Scientific guideline: Draft liposomal amphotericin B powder for dispersion for infusion 50 mg product-specific bioequivalence guidance
17/12/2021 Scientific guideline: Draft ursodeoxycholic acid capsule 250 mg, film-coated tablet 150 mg, 300 mg, 450 mg, 500 mg, 600 mg and suspension 50 mg/ml (250 mg/5 ml) product-specific bioequivalence guidance
17/12/2021 Report: Sales of veterinary antimicrobial agents in 31 European countries in 2019 and 2020 - Trends from 2010 to 2020 Eleventh ESVAC report
17/12/2021 Liposomal amphotericin B product-specific bioequivalence guidance - Scientific guideline
16/12/2021 Minutes: Minutes of the CVMP meeting of 3-4 November 2021
16/12/2021 Summary of product characteristics for antiparasitic veterinary medicinal products - Scientific guideline
16/12/2021 Scientific guideline: Guideline on the summary of product characteristics for antiparasitic veterinary medicinal products - Revision 1
16/12/2021 Report: Heterologous primary and booster COVID-19 vaccination - Evidence based regulatory considerations
16/12/2021 Other: Quick guide: How to manage a CT - CTIS Training Programme - Module 05
16/12/2021 Other: Step-by-step guide: How to manage a CT - CTIS Training Programme - Module 05
16/12/2021 Other: Instructor's guide: How to manage a CT - CTIS Training Programme - Module 05
16/12/2021 Template or form: Clinical Trial Information System (CTIS) structured data form - Multi trial substantial modification
16/12/2021 News and press releases: EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19: rolling review starts in parallel
16/12/2021 Template or form: Clinical Trial Information System (CTIS) structured data form - Notifications
16/12/2021 Template or form: Clinical Trial Information System (CTIS) structured data form - Annual Safety Report (ASR)
16/12/2021 Template or form: Clinical Trial Information System (CTIS) structured data form - Request for information (RFI)
16/12/2021 Template or form: Clinical Trial Information System (CTIS) list values
16/12/2021 News and press releases: Increase in manufacturing capacity for COVID-19 vaccines from Janssen, Moderna and BioNTech/Pfizer
16/12/2021 News and press releases: EMA recommends approval for use of Kineret in adults with COVID-19
16/12/2021 News and press releases: COVID-19: EMA recommends authorisation of antibody medicine Xevudy
16/12/2021 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
16/12/2021 Other: Instructor's guide: How to respond to Requests for Information received during the evaluation of a Clinical Trial Application - CTIS Training Programme - Module 11
16/12/2021 Scientific guideline: Draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure
16/12/2021 Guideline on the acceptability of names for human medicinal products processed through the centralised procedure - Scientific guideline
16/12/2021 Periodic safety update single assessment: Ivermectin: List of nationally authorised medicinal products - PSUSA/00010376/202104
16/12/2021 Scientific guideline: Draft ibrutinib hard capsules 140 mg and film-coated tablets 140, 280, 420 & 560 mg product-specific bioequivalence guidance
16/12/2021 Scientific guideline: Draft olaparib 100 mg & 150 mg film-coated tablets product-specific bioequivalence guidance
16/12/2021 Scientific guideline: Draft International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q9 (R1) on quality risk management - Step 2b
15/12/2021 Human medicines European public assessment report (EPAR): Seebri Breezhaler, glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 28/09/2012, 12, Authorised
15/12/2021 News and press releases: EMA launches the Regulatory Science Research Needs initiative
15/12/2021 Periodic safety update single assessment: Terlipressin: List of nationally authorised medicinal products - PSUSA/00002905/202104
15/12/2021 Periodic safety update single assessment: Risedronate: List of nationally authorised medicinal products - PSUSA-00002648-202103
15/12/2021 EMA regular press briefing on COVID-19 , Online, from 21/12/2021 to 21/12/2021
15/12/2021 ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Scientific guideline
15/12/2021 Other: EMA framework of interaction with healthcare professionals: 10 years of implementation
15/12/2021 Overview of comments: Overview of comments received on 'Draft ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Addendum - Step 2b'
15/12/2021 Recruitment: European Medicines Agency's privacy statement for selection and recruitment
15/12/2021 News and press releases: COVID-19 Vaccine Janssen: EMA recommendation on booster dose
15/12/2021 Report: PDCO monthly report of opinions on paediatric investigation plans and other activities 20-23 July 2021
15/12/2021 Human medicines European public assessment report (EPAR): Idelvion, albutrepenonacog alfa, Hemophilia B, 11/05/2016, Orphan, 10, Authorised
15/12/2021 Human medicines European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau), Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors, 10/04/2017, Orphan, Additional monitoring, Exceptional circumstances, 5, Authorised
15/12/2021 Scientific guideline: Draft enzalutamide soft capsule 40 mg and film-coated tablet 40 mg & 80 mg product-specific bioequivalence guidance
15/12/2021 Orphan designation: Zanubrutinib for the: Treatment of lymphoplasmacytic lymphoma, 29/05/2019, Withdrawn
14/12/2021 Other: Step-by-step guide: How to respond to requests for information received during the evaluation of a Clinical Trial Application - CTIS Training Programme - Module 11
14/12/2021 Veterinary medicines European public assessment report (EPAR): Nexgard Spectra, afoxolaner, milbemycin oxime, 15/01/2015, 9, Authorised
14/12/2021 Other: Step-by-step guide : Union Controls in CTIS - CTIS Training Programme - Module 21
14/12/2021 Other: FAQs : Union Controls in CTIS - CTIS Training Programme - Module 21
14/12/2021 Other: Release notes - production release version 1.5.1-0 December 2021 - Veterinary Medicinal Products Regulation: Union Product Database
14/12/2021 Other: Example files - production release version 1.5.1-0 December 2021 - Veterinary Medicinal Products Regulation: Union Product Database
14/12/2021 Other: Step-by-step guide : Create, submit and withdraw a clinical trial application and nonsubstantial modifications - CTIS Training Programme - Module 10
14/12/2021 Periodic safety update single assessment: Argipressin : List of nationally authorised medicinal products - PSUSA/00010749/202103
14/12/2021 Other: FAQs: Introduction to CTIS for public users - CTIS Training Programme - Module 22
14/12/2021 Other: Quick guide: Introduction to CTIS for public users - CTIS Training Programme - Module 22
14/12/2021 Orphan designation: Tislelizumab for the: Treatment of oesophageal cancer, 13/11/2020, Positive
14/12/2021 Human medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Schizophrenia, 14/11/2013, 19, Authorised
14/12/2021 Human medicines European public assessment report (EPAR): Sunitinib Accord, sunitinib, Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Neuroendocrine Tumors, 11/02/2021, Additional monitoring, Generic, 1, Authorised
14/12/2021 Regulatory and procedural guideline: EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 6: Examples for submission of legacy data
14/12/2021 Other: Register of deadlines to put a medicinal product on the market In accordance with Article 33 of the Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006
14/12/2021 Agenda: Agenda - PDCO agenda of the 14-17 December 2021 meeting
14/12/2021 Human medicines European public assessment report (EPAR): Jevtana, cabazitaxel, Prostatic Neoplasms, 17/03/2011, 20, Authorised
14/12/2021 Herbal medicinal product: Orthosiphonis folium, Orthosiphonis folium, F: Assessment finalised
14/12/2021 Orphan designation: 2-Hydroxypropyl-β-cyclodextrin for the: Treatment of Niemann-Pick's disease, type C, 26/04/2013, Positive
14/12/2021 Committee for Orphan Medicinal Products (COMP): 5-7 October 2021 , European Medicines Agency, Amsterdam, the Netherlands, from 05/10/2021 to 07/10/2021
14/12/2021 Human medicines European public assessment report (EPAR): Docetaxel Teva, docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms, 26/01/2010, Generic, 18, Withdrawn
14/12/2021 Minutes: Minutes of the COMP meeting 5-7 October 2021
14/12/2021 News and press releases: EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment of COVID-19
14/12/2021 Periodic safety update single assessment: Pholcodine / biclotymol / chlorphenamine maleate : List of nationally authorised medicinal products - PSUSA/00010437/202104
14/12/2021 Human medicines European public assessment report (EPAR): Taxotere, docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms, 27/11/1995, 49, Authorised
14/12/2021 Newsletter: News bulletin for small and medium-sized enterprises - Issue 54
14/12/2021 Periodic safety update single assessment: Deoxycholic acid : List of nationally authorised medicinal products - PSUSA/00010525/202104
13/12/2021 Human medicines European public assessment report (EPAR): Qinlock, ripretinib, Gastrointestinal Stromal Tumors, 18/11/2021, Orphan, Additional monitoring, 1, Authorised
13/12/2021 Periodic safety update single assessment: Metamizole : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001997/202103
13/12/2021 Periodic safety update single assessment: Metamizole : List of nationally authorised medicines - PSUSA/00001997/202103
13/12/2021 Human medicines European public assessment report (EPAR): Apidra, insulin glulisine, Diabetes Mellitus, 27/09/2004, 31, Authorised
13/12/2021 Human medicines European public assessment report (EPAR): Betaferon, interferon beta-1b, Multiple Sclerosis, 30/11/1995, 34, Authorised
13/12/2021 Newsletter: Clinical Trials Information System (CTIS) highlights - December 2021
13/12/2021 News and press releases: International regulators’ reflections on remote approaches to GCP and GMP regulatory oversight during COVID-19 pandemic
13/12/2021 Human medicines European public assessment report (EPAR): Iscover, clopidogrel, Stroke; Peripheral Vascular Diseases; Atrial Fibrillation; Myocardial Infarction; Acute Coronary Syndrome, 14/07/1998, 46, Authorised
13/12/2021 Human medicines European public assessment report (EPAR): Ventavis, iloprost, Hypertension, Pulmonary, 15/09/2003, 29, Authorised
13/12/2021 Human medicines European public assessment report (EPAR): Xarelto, rivaroxaban, Arthroplasty, Replacement; Venous Thromboembolism, 30/09/2008, Additional monitoring, 36, Authorised
13/12/2021 Human medicines European public assessment report (EPAR): Aldara, imiquimod, Condylomata Acuminata; Keratosis; Keratosis, Actinic; Carcinoma, Basal Cell, 18/09/1998, 29, Authorised
13/12/2021 Human medicines European public assessment report (EPAR): Pheburane, Sodium phenylbutyrate, Carbamoyl-Phosphate Synthase I Deficiency Disease, 30/07/2013, 10, Authorised
13/12/2021 Other: Timetable: Type II variation and worksharing application assessment - ATMP
13/12/2021 Other: Timetable: Type II variation and worksharing application monthly assessment
13/12/2021 Other: Timetable: Type II variation and worksharing application weekly assessment
13/12/2021 Other: Getting started with CTIS: Sponsor quick guide
13/12/2021 Agenda: Agenda - CHMP agenda of the 13-16 December 2021 meeting
10/12/2021 Opinion/decision on a Paediatric investigation plan (PIP): Trelegy Ellipta, fluticasone furoate,umeclidinium bromide,vilanterol trifenatate, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0058/2020
10/12/2021 Opinion/decision on a Paediatric investigation plan (PIP): Dipalmitoylphosphatidylcholine,1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol sodium salt,synthetic surfactant protein C analogue,synthetic surfactant protein B analogue (CHF 5633), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0363/2016
10/12/2021 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 25-28 October 2021 PRAC meeting
10/12/2021 Webinar on veterinary pharmacovigilance (PhV) inspections and systems, their quality management systems and PhV system master files: Introduction and principles , Online, 10:00-13:00 Amsterdam time (CET), from 08/12/2021 to 08/12/2021
10/12/2021 Maximum Residue Limits - Summary of opinion: Toltrazuril (poultry eggs) - Summary opinion of the CVMP on the extension of maximum residue limits
10/12/2021 News and press releases: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 7-9 December 2021
10/12/2021 Human medicines European public assessment report (EPAR): Neupro, rotigotine, Restless Legs Syndrome; Parkinson Disease, 15/02/2006, 31, Authorised
10/12/2021 Human medicines European public assessment report (EPAR): Capecitabine Accord, capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms, 20/04/2012, Generic, 16, Authorised
10/12/2021 News and press releases: International regulators stress continued need for COVID-19 therapeutics
10/12/2021 Minutes: Highlights - 16th industry stakeholder platform - operation of European Union (EU) pharmacovigilance
09/12/2021 Referrals document: Lagevrio (also known as molnupiravir or MK 4482) - COVID-19 - Article-5(3) procedure: Assessment report
09/12/2021 Human medicines European public assessment report (EPAR): Tafinlar, dabrafenib mesilate, Melanoma, 26/08/2013, 27, Authorised
09/12/2021 Human medicines European public assessment report (EPAR): Nevirapine Teva, nevirapine, HIV Infections, 30/11/2009, Generic, 11, Authorised
09/12/2021 Human medicines European public assessment report (EPAR): Perjeta, pertuzumab, Breast Neoplasms, 04/03/2013, 22, Authorised
09/12/2021 Human medicines European public assessment report (EPAR): Zalasta, olanzapine, Schizophrenia; Bipolar Disorder, 27/09/2007, Generic, 19, Authorised
09/12/2021 Human medicines European public assessment report (EPAR): Atazanavir Krka, atazanavir (as sulfate), HIV Infections, 25/03/2019, Generic, 1, Authorised
09/12/2021 Human medicines European public assessment report (EPAR): Wakix, pitolisant, Narcolepsy, 31/03/2016, Orphan, Additional monitoring, 13, Authorised
09/12/2021 Opinion/decision on a Paediatric investigation plan (PIP): Xagrid, Anagrelide, PM: decision on the application for modification of an agreed PIP, P/0325/2013
09/12/2021 Safety of COVID-19 vaccines
09/12/2021 Human medicines European public assessment report (EPAR): Zimbus Breezhaler, glycopyrronium bromide, Indacaterol (acetate), Mometasone furoate, Asthma, 03/07/2020, 3, Authorised
09/12/2021 Human medicines European public assessment report (EPAR): Zyclara, imiquimod, Keratosis; Keratosis, Actinic, 23/08/2012, 13, Authorised
09/12/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 9 December 2021
09/12/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 9 December 2021
09/12/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Comirnaty: 9 December 2021
09/12/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Spikevax (previously COVID-19 Vaccine Moderna): 9 December 2021
09/12/2021 Minutes: Minutes of the CHMP meeting 11-14 October 2021
09/12/2021 Veterinary medicines European public assessment report (EPAR): Innovax-ILT, Cell-associated live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus, 03/07/2015, 5, Authorised
08/12/2021 Human medicines European public assessment report (EPAR): Marixino (previously Maruxa), memantine hydrochloride, Alzheimer Disease, 28/04/2013, Generic, 8, Authorised
08/12/2021 Periodic safety update single assessment: N(2)-L-alanyl-L-glutamine : List of nationally authorised medicinal products - PSUSA/00003158/202103
08/12/2021 Human medicines European public assessment report (EPAR): Mircera, Methoxy polyethylene glycol-epoetin beta, Anemia; Kidney Failure, Chronic, 20/07/2007, 27, Authorised
08/12/2021 Human medicines European public assessment report (EPAR): Respreeza, Human alpha1-proteinase inhibitor, Genetic Diseases, Inborn; Lung Diseases, 20/08/2015, Additional monitoring, 10, Authorised
08/12/2021 Human medicines European public assessment report (EPAR): Tevagrastim, filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer, 15/09/2008, Biosimilar, 15, Authorised
08/12/2021 Human medicines European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V., budesonide, formoterol fumarate dihydrate, Asthma; Pulmonary Disease, Chronic Obstructive, 03/04/2020, 2, Authorised
08/12/2021 Human medicines European public assessment report (EPAR): Repaglinide Krka, repaglinide, Diabetes Mellitus, Type 2, 03/11/2009, Generic, 7, Authorised
08/12/2021 Human medicines European public assessment report (EPAR): Enyglid, repaglinide, Diabetes Mellitus, Type 2, 13/10/2009, Generic, 8, Authorised
08/12/2021 Human medicines European public assessment report (EPAR): Calquence, Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell, 05/11/2020, Additional monitoring, 3, Authorised
08/12/2021 Veterinary medicines European public assessment report (EPAR): Circovac, inactivated porcine circovirus type 2 (PCV2), 21/06/2007, 12, Authorised
08/12/2021 Veterinary medicines European public assessment report (EPAR): Increxxa, tulathromycin, 16/09/2020, Generic, 2, Authorised
08/12/2021 Other: Policy 51: Stress at work
08/12/2021 Report: Applications for new human medicines under evaluation by the CHMP: December 2021
08/12/2021 Quality documentation for medicinal products when used with a medical device - Scientific guideline
08/12/2021 Overview of comments: Overview of comments received on 'Draft guideline on the quality requirements for drug-device combinations - First version'
08/12/2021 Periodic safety update single assessment: Metformin : List of nationally authorised medicinal products - PSUSA/00002001/202104
08/12/2021 Periodic safety update single assessment: Amlodipine besilate / ramipril, amlodipine / hydrochlorothiazide / ramipril, hydrochlorothiazide / ramipril : List of nationally authorised medicinal products - PSUSA/00010774/202103
08/12/2021 Regulatory and procedural guideline: Names of the European Union / European Economic Area countries
08/12/2021 Regulatory and procedural guideline: Tables of non-standard abbreviations to be used in the summary of product characteristics
08/12/2021 Regulatory and procedural guideline: QRD Appendix IV - Terms and abbreviations for batch number and expiry date to be used on the labelling of human medicinal products
08/12/2021 Template or form: QRD Appendix III to the Quality Review of Documents templates for human medicinal products (Cover page)
08/12/2021 Agenda: Agenda - CAT agenda of the 8-10 December 2021 meeting
08/12/2021 Human medicines European public assessment report (EPAR): Inrebic, fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders; Primary Myelofibrosis, 08/02/2021, Orphan, Additional monitoring, 3, Authorised
08/12/2021 Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical trial sponsors - February 2022 , Online, 13:30 - 18:15 Amsterdam time (CET) , from 17/02/2022 to 17/02/2022
08/12/2021 Human medicines European public assessment report (EPAR): Ebilfumin, oseltamivir, Influenza, Human, 22/05/2014, Generic, 14, Authorised
07/12/2021 Human medicines European public assessment report (EPAR): Talzenna, talazoparib, Breast Neoplasms, 20/06/2019, Additional monitoring, 6, Authorised
07/12/2021 Committee for Herbal Medicinal Products (HMPC): 20-22 September 2021 , European Medicines Agency, Amsterdam, the Netherlands, from 20/09/2021 to 22/09/2021
07/12/2021 Minutes: Minutes of the HMPC 20-22 September 2021 meeting
07/12/2021 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: October 2021
07/12/2021 Committee meeting report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 22-24 November 2021
07/12/2021 Applying for SME status
07/12/2021 Committee for Herbal Medicinal Products (HMPC): 22-24 November 2021 , European Medicines Agency, Amsterdam, the Netherlands, from 22/11/2021 to 24/11/2021
07/12/2021 Open letters
07/12/2021 Other: EMA reply to a letter from Members of the European Parliament, Ms M. Rivasi, Mr P. Pedicini and Ms T. Metz concerning COVID-19 vaccines
07/12/2021 Committee for Medicinal Products for Human Use (CHMP): 17-20 May 2021 , European Medicines Agency, Amsterdam, the Netherlands, from 17/05/2021 to 20/05/2021
07/12/2021 Committee for Medicinal Products for Human Use (CHMP): 21-24 June 2021 , European Medicines Agency, Amsterdam, the Netherlands, from 21/06/2021 to 24/06/2021
07/12/2021 Committee for Medicinal Products for Human Use (CHMP): 19-22 April 2021 , European Medicines Agency, Amsterdam, the Netherlands, from 19/04/2021 to 22/04/2021
07/12/2021 Agenda: CHMP PROM agenda for the meeting on 14 June 2021
07/12/2021 Minutes: CHMP PROM minutes for the meeting on 14 June 2021
07/12/2021 Minutes: CHMP PROM minutes for the meeting on 10 May 2021
07/12/2021 Agenda: CHMP PROM agenda for the meeting on 10 May 2021
07/12/2021 Agenda: CHMP PROM agenda for the meeting on 12 April 2021
07/12/2021 Minutes: CHMP PROM minutes for the meeting on 12 April 2021
07/12/2021 Committee for Medicinal Products for Human Use (CHMP): 22-25 March 2021 , European Medicines Agency, Amsterdam, the Netherlands, from 22/03/2021 to 25/03/2021
07/12/2021 Veterinary medicines European public assessment report (EPAR): Ubac, Lipoteichoic acid from Biofilm Adhesion Component of Streptococcus uberis, strain 5616, 26/07/2018, 1, Authorised
07/12/2021 Withdrawn application: Aivlosin, tylvalosin, Date of withdrawal: 17/03/2021, Post-authorisation
07/12/2021 Minutes: CHMP PROM minutes for the meeting on 15 March 2021
07/12/2021 Agenda: CHMP PROM agenda for the meeting on 15 March 2021
07/12/2021 Support to SMEs
07/12/2021 Agenda: Agenda - CVMP agenda of the 7-9 December 2021 meeting
07/12/2021 Agenda: CHMP PROM agenda for the meeting on 15 February 2021
07/12/2021 Minutes: CHMP PROM minutes for the meeting on 15 February 2021
07/12/2021 Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human beta A-T87Q-globin gene for the: The treatment of sickle cell disease, 29/04/2014, Withdrawn
07/12/2021 News and press releases: EMA and ECDC recommendations on heterologous vaccination courses against COVID-19: ‘mix-and-match’ approach can be used for both initial courses and boosters
07/12/2021 Veterinary medicines European public assessment report (EPAR): Tulissin, tulathromycin, 24/04/2020, Generic, 3, Authorised
07/12/2021 Withdrawn application: Flynpovi, eflornithine, sulindac, Date of withdrawal: 12/10/2021, Initial authorisation
07/12/2021 SME Regulation and reports
07/12/2021 Veterinary medicines European public assessment report (EPAR): Bravecto Plus, fluralaner, moxidectin, 08/05/2018, 8, Authorised
07/12/2021 Periodic safety update single assessment: Dihydroergotamine: List of nationally authorised medicinal products - PSUSA/00001075/202104
07/12/2021 Periodic safety update single assessment: Dexamethasone / netilmicin: List of nationally authorised medicinal products - PSUSA/00010854/202104
07/12/2021 Human medicines European public assessment report (EPAR): Enerzair Breezhaler, indacaterol, glycopyrronium bromide, mometasone, Asthma, 03/07/2020, 3, Authorised
07/12/2021 Human medicines European public assessment report (EPAR): Pixuvri, pixantrone dimaleate, Lymphoma, Non-Hodgkin, 10/05/2012, 23, Authorised
07/12/2021 Direct healthcare professional communication (DHPC): Lymphoseek® (tilmanocept) 50 micrograms kit for radiopharmaceutical preparation: temporary extension of shelf life, Active substance: tilmanocept, DHPC type: Medicine shortage, Last updated: 07/12/2021
07/12/2021 Human medicines European public assessment report (EPAR): Vargatef, nintedanib, Carcinoma, Non-Small-Cell Lung, 21/11/2014, 17, Authorised
07/12/2021 Financial advantages of SME status
06/12/2021 EMA regular press briefing on COVID-19 , from 09/12/2021 to 09/12/2021
06/12/2021 Newsletter: Human medicines highlights - December 2021
06/12/2021 Periodic safety update single assessment: Budesonide: List of nationally authorised medicinal products - PSUSA/00000449/202104
06/12/2021 Human medicines European public assessment report (EPAR): Ratiograstim, filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer, 15/09/2008, Biosimilar, 14, Authorised
06/12/2021 Classifications as minor-use-minor-species and limited-market according to former EMA policy
06/12/2021 Periodic safety update single assessment: Tobramycin (ophthalmic and otic use): List of nationally authorised medicinal products - PSUSA/00009317/202103
06/12/2021 Periodic safety update single assessment: List of nationally authorised medicinal products - PSUSA/00002786/202103
06/12/2021 News and press releases: ICMRA high-level meeting on global health emergencies and regulatory approaches
06/12/2021 Periodic safety update single assessment: Tafluprost: List of nationally authorised medicinal products - PSUSA/00002843/202104
06/12/2021 Agenda: Agenda - EU Big Data Stakeholder Forum 2021
06/12/2021 News and press releases: EMA recommends approval for use of RoActemra in adults with severe COVID-19
06/12/2021 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - June 2022 , Online, from 27/06/2022 to 29/06/2022
06/12/2021 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - February 2022 , Online, from 14/02/2022 to 16/02/2022
06/12/2021 eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - May 2022 , Online, from 02/05/2022 to 04/05/2022
06/12/2021 16th industry stakeholder platform - operation of European Union (EU) pharmacovigilance , Online, 09:00 - 13:15 Amsterdam time (CET), from 17/11/2021 to 17/11/2021
06/12/2021 Agenda: Agenda - COMP agenda of the 7-9 December 2021 meeting
06/12/2021 Procurement: Ex ante publicity of a negotiated procedure - EMA/2021/19/LD - Legal advice in relation to Dutch employment and labour law
06/12/2021 Periodic safety update single assessment: Plasma protein fraction: List of nationally authorised medicinal products - PSUSA/00002449/202104
03/12/2021 Human medicines European public assessment report (EPAR): Renagel, sevelamer, Renal Dialysis; Hyperphosphatemia, 28/01/2000, 34, Authorised
03/12/2021 News and press releases: ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic
03/12/2021 Veterinary medicines European public assessment report (EPAR): Suvaxyn CSF Marker, Live Recombinant E2 gene-deleted bovine viral diarrhoea virus containing classical swine fever virus E2 gene (CP7_E2alf), 10/02/2015, 4, Authorised
03/12/2021 Periodic safety update single assessment: Oxaliplatin - List of nationally authorised medicinal products - PSUSA/00002229/202104
03/12/2021 Periodic safety update single assessment: Ozenoxacin - List of nationally authorised medicinal products - PSUSA/00010651/202105
03/12/2021 Orphan designation: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains (idecabtagene vicleucel) for the: Treatment of multiple myeloma, 20/04/2017, Positive