|
31/05/2022 |
Periodic safety update single assessment: Dexamfetamine : List of nationally authorised medicinal products - PSUSA/00000986/202109
|
|
31/05/2022 |
Human medicines European public assessment report (EPAR): Ponvory, ponesimod, Multiple Sclerosis, Relapsing-Remitting, 19/05/2021,  , 2, Authorised |
|
31/05/2022 |
Periodic safety update single assessment: Dexamfetamine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000986/202109
|
|
31/05/2022 |
Other: Frequently asked questions about parallel distribution
|
|
31/05/2022 |
Frequently asked questions about parallel distribution |
|
31/05/2022 |
Other: Variation fast healthcare interoperability resources (FHIR) mapping & examples
|
|
31/05/2022 |
Digital application dataset integration (DADI) webinar - common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Article 57(2) and electronic application forms (eAF)
, Online, 10:30 - 12:00 Amsterdam time (CET), from 25/01/2022 to 25/01/2022 |
|
31/05/2022 |
Periodic safety update single assessment: Modafinil : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010242/202108
|
|
31/05/2022 |
Periodic safety update single assessment: Modafinil : List of nationally authorised medicinal products - PSUSA/00010242/202108
|
|
31/05/2022 |
Minutes: Minutes of the CHMP meeting 21-24 March 2022
|
|
31/05/2022 |
Committee for Advanced Therapies (CAT): 3-5 November 2021
, European Medicines Agency, Amsterdam, the Netherlands, from 03/11/2021 to 05/11/2021 |
|
31/05/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): outer membrane vesicles (OMV) from n. meningitidis strain NZ 98/254,recombinant neisseria meningitis group B Protein 936-741,meningococcal group W-135 oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein,meningococcal group A oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein,meningococcal group C oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein,recombinant neisseria meningitis group B Protein 287-953,recombinant neisseria meningitis group B Protein 961c,meningococcal group Y oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein (MenABCWY), PM: decision on the application for modification of an agreed PIP, P/0231/2020 |
|
31/05/2022 |
Minutes: Minutes of the CAT meeting 3-5 November 2021
|
|
31/05/2022 |
Periodic safety update single assessment: Isotretinoin (oral formulations) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/202105
|
|
31/05/2022 |
European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting
, Online, from 02/03/2022 to 03/03/2022 |
|
31/05/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Enasidenib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0293/2017 |
|
30/05/2022 |
Periodic safety update single assessment: Dexketoprofen and tramadol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/S/0035
|
|
30/05/2022 |
Periodic safety update single assessment: Dexketoprofen and tramadol : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0035
|
|
30/05/2022 |
EMA regular press briefing on COVID-19
, Online, 14:30 - 15:00 Amsterdam time (CEST), from 02/06/2022 to 02/06/2022 |
|
25/05/2022 |
DARWIN EU Advisory Board meeting: 16 February 2022
, Online, from 16/02/2022 to 16/02/2022 |
|
25/05/2022 |
Human medicines European public assessment report (EPAR): Glyxambi, empagliflozin, linagliptin, Diabetes Mellitus, Type 2, 11/11/2016, 15, Authorised |
|
25/05/2022 |
Human medicines European public assessment report (EPAR): Synjardy, empagliflozin, metformin, Diabetes Mellitus, Type 2, 27/05/2015, 24, Authorised |
|
25/05/2022 |
Human medicines European public assessment report (EPAR): Erbitux, cetuximab, Head and Neck Neoplasms; Colorectal Neoplasms, 29/06/2004, 29, Authorised |
|
25/05/2022 |
Other: Antimicrobial use data reporting per animal categories (numerator) - Manual for reporting the data to EMA
|
|
25/05/2022 |
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, 35, Authorised |
|
25/05/2022 |
Human medicines European public assessment report (EPAR): Firdapse (previously Zenas), amifampridine, Lambert-Eaton Myasthenic Syndrome, 23/12/2009, ,  , 21, Authorised |
|
25/05/2022 |
Other: EMA medical terms simplifier
|
|
25/05/2022 |
Third Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry
, Online, from 04/05/2022 to 04/05/2022 |
|
25/05/2022 |
Other: FAQs: Supervise a Clinical Trial and a Clinical Trial: Inspection records - CTIS Training Programme - Module 16
|
|
25/05/2022 |
EMA and European Infrastructure for Translational Research (EATRIS) webinar on Scientific Advice for Advanced Therapy Medicinal Products (ATMPs): what and when to ask
, Online, 13.00 - 14.00 Amsterdam time (CEST), from 10/06/2022 to 10/06/2022 |
|
25/05/2022 |
Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 16-19 May 2022
|
|
25/05/2022 |
Newsletter: Clinical Trials Highlights - May 2022
|
|
24/05/2022 |
Other: Example files - production release version 1.6.4 May 2022 - Veterinary Medicinal Products Regulation: Union Product Database
|
|
24/05/2022 |
Evaluation of anticancer medicinal products in man - Scientific guideline |
|
24/05/2022 |
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)
, Online, 10:00 - 11:00 Amsterdam time (CEST), from 25/05/2022 to 25/05/2022 |
|
24/05/2022 |
Human medicines European public assessment report (EPAR): Amifampridine SERB, amifampridine phosphate, Lambert-Eaton Myasthenic Syndrome; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Nervous System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Neuromuscular Diseases; Neuromuscular Junction Diseases; Immune System Diseases; Autoimmune Diseases; Autoimmune Diseases of the Nervous System; Cancer; Neoplasms, 19/05/2022,  , Authorised |
|
24/05/2022 |
Procurement: Ex ante publicity of a negotiated procedure: EMA-2022-06-ST - Provision of external meeting and conference facilities
|
|
24/05/2022 |
Human medicines European public assessment report (EPAR): Actos, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 13/10/2000, 29, Authorised |
|
24/05/2022 |
News and press releases: EMA business hours over Ascension Day holidays, 26 and 27 May |
|
24/05/2022 |
News and press releases: EMA guidance supports development of new antibiotics |
|
24/05/2022 |
Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - Scientific guideline |
|
24/05/2022 |
Orphan designation: Tipifarnib
for the: Treatment of peripheral T-cell lymphoma, 19/10/2020, Positive |
|
24/05/2022 |
Orphan designation: 3-(3-(3,5-bis(trifluoromethyl)phenyl)-1h-pyrazol-1-yl)propanoic acid
for the: Treatment of Stargardt's disease, 24/04/2019, Positive |
|
24/05/2022 |
Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate
for the: Treatment of cystic fibrosis, 26/10/2018, Positive |
|
24/05/2022 |
Antimicrobial resistance in human medicine |
|
24/05/2022 |
Orphan designation: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate
for the: Treatment of mucopolysaccharidosis type I, 22/09/2016, Positive |
|
24/05/2022 |
Orphan designation: N-methyl-4-({4-[({3-methyl(methylsulfonyl)aminopyrazin-2-yl}methyl)amino]-5-(trifluoromethyl)pyrimidin-2-yl}amino)benzamide hydrochloride (defactinib)
for the: Treatment of ovarian cancer, 15/01/2015, Positive |
|
24/05/2022 |
Orphan designation: Tipifarnib
for the: Treatment of acute myeloid leukaemia, 10/03/2005, Positive |
|
24/05/2022 |
Human medicines European public assessment report (EPAR): Ipique, bevacizumab, Wet Macular Degeneration, 29/04/2022, Refused |
|
24/05/2022 |
Human medicines European public assessment report (EPAR): Pantozol Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 16, Authorised |
|
24/05/2022 |
Human medicines European public assessment report (EPAR): Somac Control, pantoprazole, Gastroesophageal Reflux, 12/06/2009, 15, Authorised |
|
24/05/2022 |
Human medicines European public assessment report (EPAR): Controloc Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 14, Authorised |
|
20/05/2022 |
Periodic safety update single assessment: Allergen for therapy: Ambrosia Artemisiifolia (302) (sublingual use, products authorised via decentralised procedure) : List of nationally authorised medicinal products - PSUSA/00010693/202110
|
|
20/05/2022 |
Withdrawn application: Neffy, epinephrine, Date of withdrawal: 04/04/2022, Initial authorisation |
|
20/05/2022 |
Human medicines European public assessment report (EPAR): Rasilez HCT, aliskiren, hydrochlorothiazide, Hypertension, 16/01/2009, 17, Withdrawn |
|
20/05/2022 |
European Medicines Agency veterinary medicines info day 2022
, Online, from 12/05/2022 to 13/05/2022 |
|
20/05/2022 |
Human medicines European public assessment report (EPAR): Docetaxel Zentiva (previously Docetaxel Winthrop), docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms, 20/04/2007, 30, Withdrawn |
|
20/05/2022 |
Human medicines European public assessment report (EPAR): Riltrava Aerosphere, budesonide, formoterol fumarate dihydrate, glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 06/01/2022, 1, Authorised |
|
20/05/2022 |
Human medicines European public assessment report (EPAR): Trixeo Aerosphere, formoterol fumarate dihydrate, glycopyrronium bromide, budesonide, Pulmonary Disease, Chronic Obstructive, 09/12/2020, 3, Authorised |
|
20/05/2022 |
Regulatory and procedural guideline: EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information
|
|
20/05/2022 |
Other: EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 7: Submission of other post-authorisation data
|
|
20/05/2022 |
Human medicines European public assessment report (EPAR): Breyanzi, CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells), Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms, 04/04/2022, , Authorised |
|
20/05/2022 |
Report: Annual Report of the Good Clinical Practice Inspectors' Working Group 2020
|
|
20/05/2022 |
News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2022 |
|
20/05/2022 |
News and press releases: First treatment for children with Progeria or progeroid like syndromes (rare premature aging syndromes) |
|
20/05/2022 |
News and press releases: First therapy to treat rare genetic nervous system disorder AADC deficiency |
|
20/05/2022 |
News and press releases: Synchron Research Service: suspension of medicines over flawed studies |
|
20/05/2022 |
News and press releases: First therapy to treat two types of Niemann-Pick disease, a rare genetic metabolic disorder |
|
20/05/2022 |
Other: Mandatory use of ISO ICSR/ICH E2B(R3) and EDQM terminology for Dosage Forms (DF) and Routes of Administration (RoA)
|
|
20/05/2022 |
Other: Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - EMBASE
|
|
20/05/2022 |
Report: Medicinal products for human use: monthly figures - April 2022
|
|
20/05/2022 |
Data requirements for multi-strain dossiers for inactivated veterinary vaccines - Scientific guideline |
|
20/05/2022 |
Procedural advice for veterinary vaccine antigen master file (VAMF) certification - Procedural Guidance |
|
20/05/2022 |
Scientific guideline: Draft procedural advice for vaccine platform technology master file (vPTMF) certification
|
|
20/05/2022 |
Scientific guideline: Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes - Revision 2
|
|
20/05/2022 |
Report: Key performance indicators (KPIs) to monitor the European clinical trials environment (31 January - 30 April 2022)
|
|
20/05/2022 |
Human medicines European public assessment report (EPAR): Xospata, gilteritinib fumarate, Leukemia, Myeloid, Acute, 24/10/2019,  , , 3, Authorised |
|
20/05/2022 |
Clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - Scientific guideline |
|
20/05/2022 |
Environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 - Scientific guideline |
|
20/05/2022 |
Other: Questions and answers: implementation of CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 (Phase I) and GL38 (Phase II)
|
|
19/05/2022 |
External whistleblowing policy |
|
19/05/2022 |
Minutes: Minutes of the CVMP meeting of 11-13 April 2022
|
|
19/05/2022 |
Committee for Herbal Medicinal Products (HMPC): 28-30 March 2022
, from 28/03/2022 to 30/03/2022 |
|
19/05/2022 |
Minutes: Minutes of the HMPC 28-30 March 2022 meeting
|
|
19/05/2022 |
Orphan designation: tisagenlecleucel
for the: Treatment of follicular lymphoma, 19/07/2021, Positive |
|
19/05/2022 |
Report: COMP meeting report on the review of applications for orphan designation: May 2022
|
|
19/05/2022 |
Good pharmacovigilance practices |
|
19/05/2022 |
Human medicines European public assessment report (EPAR): Apixaban Accord, Apixaban, Venous Thromboembolism; Stroke; Arthroplasty, 23/07/2020, , 2, Authorised |
|
19/05/2022 |
Orphan designation: Inebilizumab
for the: Treatment of neuromyelitis optica spectrum disorders, 20/03/2017, Withdrawn |
|
19/05/2022 |
Orphan designation: Lefitolimod
for the: Treatment of small cell lung cancer, 26/03/2021, Positive |
|
18/05/2022 |
Orphan designation: avapritinib
for the: Treatment of mastocytosis, 26/10/2018, Positive |
|
18/05/2022 |
Human medicines European public assessment report (EPAR): Alunbrig, brigatinib, Carcinoma, Non-Small-Cell Lung, 22/11/2018, , 8, Authorised |
|
18/05/2022 |
Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva, efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections, 17/07/2017, , 8, Authorised |
|
18/05/2022 |
Other: Speakers' biographies - Clinical Trials Information System (CTIS) bitesize talk: Transitional trials and additional Member State concerned (MSC) application
|
|
18/05/2022 |
Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector encoding glucosylceramidase beta
for the: Treatment of Gaucher disease, 21/08/2020, Positive |
|
18/05/2022 |
Agenda: Agenda of the PDCO meeting 17-20 May 2022
|
|
18/05/2022 |
Orphan designation: Autologous CD34+ cells transduced with a lentiviral RNA vector that results in integrated cDNA encoding for functional cystinosin
for the: Treatment of cystinosis, 19/02/2021, Positive |
|
18/05/2022 |
Orphan designation: synthetic human hepcidin
for the: Treatment of sickle cell disease, 18/11/2016, Withdrawn |
|
18/05/2022 |
Orphan designation: Synthetic hepcidin
for the: Treatment of beta thalassaemia intermedia and major, 09/10/2015, Withdrawn |
|
17/05/2022 |
EMA-hosted virtual meetings |
|
17/05/2022 |
Newsletter: News bulletin for small and medium-sized enterprises - Issue 55
|
|
17/05/2022 |
Other: Clinical trials information system - Key information for sponsors on CTIS
|
|
17/05/2022 |
Human medicines European public assessment report (EPAR): Selincro, Nalmefene hydrochloride dihydrate, Alcohol-Related Disorders, 24/02/2013, 13, Authorised |
|
17/05/2022 |
News and press releases: International regulators and WHO: support healthcare professionals to enhance public confidence in COVID-19 vaccines |
|
17/05/2022 |
Human medicines European public assessment report (EPAR): Leflunomide Zentiva (previously Leflunomide Winthrop), leflunomide, Arthritis, Rheumatoid; Arthritis, Psoriatic, 08/01/2010, 18, Authorised |
|
17/05/2022 |
Newsletter: Veterinary Medicinal Products Regulation highlights - Issue 10
|
|
17/05/2022 |
Human medicines European public assessment report (EPAR): Leflunomide ratiopharm, leflunomide, Arthritis, Rheumatoid, 28/11/2010, , 16, Authorised |
|
17/05/2022 |
Other: FAQs: How to evaluate an Initial Clinical Trial Application: Assessment and Decision - CTIS Training Programme - Module 08
|
|
17/05/2022 |
Scientific guideline: Draft lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg product specific bioequivalence guidance
|
|
16/05/2022 |
Periodic safety update single assessment: Amlodipine / rosuvastatin, perindopril / amlodipine / rosuvastatin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010434/202107
|
|
16/05/2022 |
Periodic safety update single assessment: Amlodipine / rosuvastatin, perindopril / amlodipine / rosuvastatin : List of nationally authorised medicinal products - PSUSA/00010434/202107
|
|
16/05/2022 |
Report: Applications for new human medicines under evaluation by the CHMP: May 2022
|
|
16/05/2022 |
Agenda: Agenda of the HMPC meeting 16-18 May 2022
|
|
16/05/2022 |
Orphan designation: 6-{[(1R,2S)-2-aminocyclohexyl]amino}-7-fluoro-4-(1-methyl-1H-pyrazol-4-yl)-1,2-dihydro-3H-pyrrolo[3,4-c]pyridin-3-one monocitrate (also known as mivavotinib)
for the: Treatment of acute myeloid leukaemia, 22/02/2018, Positive |
|
16/05/2022 |
Orphan designation: pentosan polysulfate sodium
for the: Treatment of interstitial cystitis, 30/05/2016, Positive |
|
13/05/2022 |
Human medicines European public assessment report (EPAR): Tobi Podhaler, Tobramycin, Cystic Fibrosis; Respiratory Tract Infections, 20/07/2011, , 19, Authorised |
|
13/05/2022 |
Human medicines European public assessment report (EPAR): Ongentys, opicapone, Parkinson Disease, 24/06/2016, 8, Authorised |
|
13/05/2022 |
Human medicines European public assessment report (EPAR): Voncento, Human coagulation factor VIII, human von willebrand factor, Hemophilia A; von Willebrand Diseases, 12/08/2013, 15, Authorised |
|
13/05/2022 |
Human medicines European public assessment report (EPAR): Abraxane, paclitaxel, Breast Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung, 11/01/2008, 29, Authorised |
|
13/05/2022 |
News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 May 2022 |
|
13/05/2022 |
Summary of opinion: Suprelorin, deslorelin acetate, 12/05/2022, Positive |
|
13/05/2022 |
News and press releases: Gerrit Johan Schefferlie elected new Chair of EMA Committee for Veterinary Medicinal Products (CVMP) |
|
13/05/2022 |
Maximum Residue Limits - Summary of opinion: Ketoprofen (poultry) - Summary opinion of the CVMP on the extension of maximum residue limits
|
|
13/05/2022 |
Regulatory and procedural guideline: Public consultation concerning the physical attendance and the location of personal residency of the qualified person
|
|
13/05/2022 |
Orphan designation: Enzastaurin hydrochloride
for the: Treatment of Ehlers-Danlos syndrome, 24/02/2022, Positive |
|
13/05/2022 |
Orphan designation: Epcoritamab
for the: Treatment of diffuse large B-cell lymphoma, 24/02/2022, Positive |
|
12/05/2022 |
Other: FAQs: Support with workload management by workspace - CTIS Training Programme - Module 04
|
|
12/05/2022 |
Minutes: Minutes of the PRAC meeting 5 August 2021
|
|
12/05/2022 |
Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Scientific guideline |
|
12/05/2022 |
Periodic safety update single assessment: Tolterodine : List of nationally authorised medicinal products - PSUSA 00002993 202109
|
|
12/05/2022 |
Quality of herbal medicinal products/traditional herbal medicinal products - Scientific guideline |
|
12/05/2022 |
COVID-19 vaccine safety update: COVID-19 vaccines - Safety update: 12 May 2022
|
|
12/05/2022 |
Human medicines European public assessment report (EPAR): Ozawade, pitolisant, Sleep Apnea, Obstructive, 01/09/2021, 2, Authorised |
|
12/05/2022 |
Human medicines European public assessment report (EPAR): Arsenic trioxide Accord, Arsenic trioxide, Leukemia, Promyelocytic, Acute, 14/11/2019, , 5, Authorised |
|
12/05/2022 |
Human medicines European public assessment report (EPAR): Inflectra, infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid, 10/09/2013,  , 29, Authorised |
|
12/05/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Glepaglutide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0455/2021 |
|
12/05/2022 |
Human medicines European public assessment report (EPAR): Galafold, migalastat hydrochloride, Fabry Disease, 25/05/2016, , , 15, Authorised |
|
11/05/2022 |
Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) |
|
11/05/2022 |
Other: Methodology for the establishment of lists of “main therapeutic groups” in crisis preparedness and of the lists of “critical medicines” in the context of a major event and/or public health emergency
|
|
11/05/2022 |
Agenda: Agenda of the CAT meeting 11-13 May 2022
|
|
11/05/2022 |
Agenda: Agenda - Digital application dataset integration (DADI) and Product Management Service (PMS) webinar - Variations form for human medicinal products - What will happen at go-live
|
|
11/05/2022 |
Clinical Trials Information System (CTIS) bitesize talk: Initial clinical trial application
, Online, 14:00 - 15:30 Amsterdam time (CET), from 23/03/2022 to 23/03/2022 |
|
11/05/2022 |
Periodic safety update single assessment: Leuprorelin (depot formulations) : List of nationally authorised medicinal products - PSUSA/00010877/202107
|
|
11/05/2022 |
Periodic safety update single assessment: Gadoteric acid (IV and intravascular formulations) : List of nationally authorised medicinal products - PSUSA/00001506/202108
|
|
11/05/2022 |
Human medicines European public assessment report (EPAR): Infanrix Hexa, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis B surface antigen, poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain)), Haemophilus influenzae type b polysaccharide, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria, 23/10/2000, 44, Authorised |
|
11/05/2022 |
Orphan designation: Adeno-associated viral vector LK03 encoding human methylmalonyl-CoA mutase
for the: Treatment of methylmalonic acidaemia, 21/06/2021, Positive |
|
11/05/2022 |
Orphan designation: H-D-valyl1-D-alanyl-D-glutamyl-D-alanyl-D-arginyl5-D-glutamyl-D-glutamyl-D-leucyl-D-glutamyl-D-arginyl10-D-leucyl-D-glutamyl-D-alanyl-D-arginyl-D-leucyl15-glycyl-D-glutaminyl-D-alanyl-D-arginyl-glycyl20-D-glutamyl-D-leucyl-D-lysyl-D-lysyl-D-tryptophyl25-D-lysyl-D-methionyl-D-arginyl-D-arginyl-D-asparaginyl30-D-glutaminyl-D-phenylalanyl-D-tryptophyl-D-leucyl-D-lysyl35-D-leucyl-D-glutaminyl-D-arginine
for the: Treatment of glioma, 21/06/2021, Positive |
|
11/05/2022 |
Orphan designation: Humanised monoclonal antibody derivative against fibroblast growth factor receptor 3
for the: Treatment of achondroplasia, 21/06/2021, Positive |
|
11/05/2022 |
Orphan designation: melatonin
for the: Prevention of retinopathy of prematurity, 21/06/2021, Positive |
|
11/05/2022 |
Other: Timetable: Companion diagnostic initial consultation
|
|
11/05/2022 |
Other: Timetable: Companion diagnostic initial consultation - ATMP
|
|
11/05/2022 |
Agenda: Agenda of the COMP meeting 10-12 May 2022
|
|
11/05/2022 |
Orphan designation: Hydrocortisone hydrogen succinate
for the: Prevention of bronchopulmonary dysplasia, 21/06/2021, Positive |
|
11/05/2022 |
Orphan designation: Bomedemstat ditosilate
for the: Treatment of essential thrombocythaemia, 21/06/2021, Positive |
|
11/05/2022 |
Orphan designation: Adeno-associated virus serotype 9 containing the human FXN gene isoform 1
for the: Treatment of Friedreich's ataxia, 21/06/2021, Withdrawn |
|
11/05/2022 |
Orphan designation: imatinib
for the: Treatment of pulmonary arterial hypertension, 21/06/2021, Positive |
|
11/05/2022 |
Orphan designation: (S)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropane-2-yl)-1H-pyrazole-4-carboxamide
for the: Treatment of mantle cell lymphoma, 21/06/2021, Positive |
|
11/05/2022 |
Orphan designation: Allogenic placenta-derived mesenchymal stromal cells secretome
for the: Treatment of pre-eclampsia, 21/06/2021, Positive |
|
11/05/2022 |
Orphan designation: Adeno-associated virus serotype 9 expressing human CLN5
for the: Treatment of neuronal ceroid lipofuscinosis, 21/06/2021, Positive |
|
11/05/2022 |
Orphan designation: Tislelizumab
for the: Treatment of nasopharyngeal cancer, 21/06/2021, Positive |
|
11/05/2022 |
Orphan designation: Humanised IgG2 monoclonal antibody against TNFSF13
for the: Treatment of primary IgA nephropathy, 21/06/2021, Positive |
|
11/05/2022 |
Orphan designation: L-ergothioneine
for the: Treatment of cystinuria, 21/06/2021, Positive |
|
10/05/2022 |
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 |
|
10/05/2022 |
Human medicines European public assessment report (EPAR): Fampridine Accord, Fampridine, Multiple Sclerosis, 24/09/2020, , 1, Authorised |
|
10/05/2022 |
Human medicines European public assessment report (EPAR): Rivastigmine Actavis, rivastigmine hydrogen tartrate, Dementia; Alzheimer Disease; Parkinson Disease, 16/06/2011, , 16, Authorised |
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10/05/2022 |
Human medicines European public assessment report (EPAR): Mavenclad, Cladribine, Multiple Sclerosis, 22/08/2017, 8, Authorised |
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10/05/2022 |
Minutes: Minutes of the PRAC meeting 5-8 July 2021
|
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10/05/2022 |
Report: Stakeholder engagement report 2020-2021
|
|
10/05/2022 |
Agenda: Agenda of the CVMP meeting 10-12 May 2022
|
|
10/05/2022 |
Orphan designation: Obeticholic acid
for the: Treatment of primary sclerosing cholangitis, 16/03/2014, Withdrawn |
|
10/05/2022 |
Orphan designation: N-(2-amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide (mocetinostat)
for the: Treatment of Hodgkin's lymphoma, 14/09/2007, Withdrawn |
|
10/05/2022 |
Periodic safety update single assessment: Opium : List of nationally authorised medicinal products - PSUSA/00010670/202109
|
|
06/05/2022 |
Other: Rules of procedure of the Emergency Task Force (ETF)
|
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06/05/2022 |
EMA’s governance during COVID-19 pandemic |
|
06/05/2022 |
Overview of comments: Overview of comments received on draft qualification opinion on IMI PREFER
|
|
06/05/2022 |
Direct healthcare professional communication (DHPC): Rucaparib (Rubraca® ): interim data from Study CO-338-043 (ARIEL4) show a decrease in overall survival compared to standard of care, Active substance: rucaparib camsylate, DHPC type: Referral - Article 20 procedure, Last updated: 06/05/2022 |
|
06/05/2022 |
News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2022 |
|
06/05/2022 |
Clinical Trials Information System (CTIS): Walk-in clinic - March 2022
, Online, 16:00 - 17:00 Amsterdam time (CEST), from 28/03/2022 to 28/03/2022 |
|
06/05/2022 |
Newsletter: Human medicines highlights - May 2022
|
|
06/05/2022 |
Minutes: Minutes of the HMPC 24-26 January 2022 meeting
|
|
06/05/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Kevzara, sarilumab, PM: decision on the application for modification of an agreed PIP, P/0114/2021 |
|
05/05/2022 |
Orphan designation: Mannitolum
for the: Treatment of cystic fibrosis, 07/11/2005, Expired |
|
05/05/2022 |
Regulatory and procedural guideline: Annex VII to procedure for conducting GCP inspections requested by the CHMP: Bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials
|
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05/05/2022 |
Regulatory and procedural guideline: Annex VI to procedure for conducting GCP inspections requested by the CHMP: Record keeping and archiving of documents
|
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05/05/2022 |
Regulatory and procedural guideline: Annex IV to procedure for conducting GCP inspections requested by the CHMP: Sponsor and Contract Research Organisations (CRO)
|
|
05/05/2022 |
Regulatory and procedural guideline: Annex I to procedure for conducting GCP inspections requested by the CHMP: Investigator site
|
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05/05/2022 |
Regulatory and procedural guideline: Annex II to procedure for conducting GCP inspections requested by the CHMP: Clinical laboratories
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05/05/2022 |
Orphan designation: Mercaptopurine
for the: Treatment of acute lymphoblastic leukaemia, 30/04/2009, Expired |
|
05/05/2022 |
Orphan designation: Allogenic fetal mesenchymal stem cells
for the: Treatment of osteogenesis imperfecta, 10/12/2021, Positive |
|
05/05/2022 |
Orphan designation: Octreotide acetate
for the: Treatment of idiopathic intracranial hypertension, 10/12/2021, Positive |
|
05/05/2022 |
Human medicines European public assessment report (EPAR): Tepmetko, Tepotinib hydrochloride monohydrate, Carcinoma, Non-Small-Cell Lung, 16/02/2022, , Authorised |
|
05/05/2022 |
Orphan designation: Troriluzole hydrochloride
for the: Treatment of spinocerebellar ataxia, 10/12/2021, Positive |
|
05/05/2022 |
Report: PDCO meeting report of opinions on paediatric investigation plans and other activities 22-25 March 2022
|
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05/05/2022 |
Orphan designation: 2’-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3’-O->5’-O)-2’-O-(2-methoxyethyl)-5-methyl-P-thiouridylyl-(3’-O->5’-O)-2’-O-(2-methoxyethyl)-P-thioguanylyl-(3’-O->5’-O)-2’-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3’-O->5’-O)-2’-O-(2-methoxyethyl)-P-thioadenylyl-(3’-O->5’-O)-2’-O-(2-methoxyethyl)-P-thioadenylyl-(3’-O->5’-O)-2’-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3’-O->5’-O)-2’-O-(2-methoxyethyl)-P-thioadenylyl-(3’-O->5’-O)-2’-O-(2-methoxyethyl)-P-thioguanoylyl-(3’-O->5’-O)-2’-O-(2-methoxyethyl)-P-thioadenylyl-(3’-O->5’-O)-2’-O-(2-methoxyethyl)-5-methyl-P-thiouridylyl-(3’-O->5’-O)-2’-O-(2-methoxyethyl)-P-thioguanylyl-(3’-O->5’-O)-2’-O-(2-methoxyethyl)-P-thioguanylyl ...
for the: Treatment of cystic fibrosis, 10/12/2021, Positive |
|
05/05/2022 |
Human medicines European public assessment report (EPAR): Fampyra, Fampridine, Multiple Sclerosis, 20/07/2011, 16, Authorised |
|
05/05/2022 |
News and press releases: EMA business hours on Europe Day, Monday 9 May |
|
05/05/2022 |
Human medicines European public assessment report (EPAR): Cervarix, human papillomavirus1 type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections; Uterine Cervical Dysplasia; Immunization, 20/09/2007, 38, Authorised |
|
04/05/2022 |
Minutes: PDCO minutes of the 18-21 January 2022 meeting
|
|
04/05/2022 |
Minutes: Minutes of the PRAC meeting 7-10 June 2021
|
|
04/05/2022 |
Orphan designation: N- (2-Amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide (mocetinostat)
for the: Treatment of acute myeloid leukaemia, 31/01/2008, Withdrawn |
|
04/05/2022 |
Orphan designation: Lisocabtagene maraleucel
for the: Treatment of primary mediastinal large B-cell lymphoma, 19/11/2018, Withdrawn |
|
04/05/2022 |
Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor (lisocabtagene maraleucel)
for the: Treatment of follicular lymphoma, 25/05/2018, Withdrawn |
|
04/05/2022 |
Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor (lisocabtagene maraleucel)
for the: Treatment of diffuse large B-cell lymphoma, 17/07/2017, Withdrawn |
|
04/05/2022 |
Other: FAQs: User access management - CTIS Training Programme - Module 03
|
|
04/05/2022 |
Other: Quick guide: User access management - CTIS Training Programme - Module 03
|
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04/05/2022 |
Other: Quick guide: How to use the Organisation Management Service (OMS) - CTIS Training Programme - Module 03
|
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03/05/2022 |
Procurement activities 2022 |
|
03/05/2022 |
Regulatory and procedural guideline: Qualification opinion on IMI PREFER
|
|
03/05/2022 |
Orphan designation: Human culture expanded autologous mesenchymal stromal cells
for the: Treatment of amyotrophic lateral sclerosis, 24/04/2019, Positive |
|
03/05/2022 |
ICH Q3D Elemental impurities - Scientific guideline |
|
03/05/2022 |
Report: COMP meeting report on the review of applications for orphan designation: April 2022
|
|
03/05/2022 |
Template or form: Change of applicant checklist - pre-submission guidance (veterinary)
|
|
03/05/2022 |
Template or form: Change of applicant - Cover letter standard text (veterinary)
|
|
03/05/2022 |
Orphan designation: Adeno-associated virus vector serotype 9 encoding the human GRN gene
for the: Treatment of frontotemporal dementia, 10/12/2021, Positive |
|
03/05/2022 |
Orphan designation: Unesbulin
for the: Treatment of soft tissue sarcoma, 10/12/2021, Positive |
|
03/05/2022 |
Report: Stakeholder engagement highlights 2021
|
|
03/05/2022 |
Human medicines European public assessment report (EPAR): Alimta, pemetrexed, Mesothelioma; Carcinoma, Non-Small-Cell Lung, 20/09/2004, 27, Authorised |
|
03/05/2022 |
Orphan designation: Norrin (25-133), Lys86Pro
for the: Treatment of familial exudative vitreoretinopathy, 10/12/2021, Positive |
|
02/05/2022 |
Minutes: Minutes of the CHMP meeting 21-24 February 2022
|
|
02/05/2022 |
Agenda: Agenda of the PRAC meeting 2-5 May 2022
|
|
02/05/2022 |
PRAC recommendation on signal: PRAC recommendations on signals adopted at the 4-7 April 2022 PRAC meeting
|
|
02/05/2022 |
Other: Release notes - production release version 1.6.3 May 2022 - Veterinary Medicinal Products Regulation: Union Product Database
|
|
02/05/2022 |
Other: Example files - production release version 1.6.3 May 2022 - Veterinary Medicinal Products Regulation: Union Product Database
|
|
02/05/2022 |
Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System
, Online, 09:00 - 14:00 Amsterdam time (CET), from 18/05/2022 to 20/05/2022 |
