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12/01/2023 |
PIP - Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision: Relamorelin - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision
|
|
12/01/2023 |
Human medicines European public assessment report (EPAR): Betaferon, interferon beta-1b, Multiple Sclerosis, 30/11/1995, 35, Authorised |
|
12/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Natpar, Recombinant parathyroid hormone, PM: decision on the application for modification of an agreed PIP, P/0369/2021 |
|
12/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Mysimba, bupropion hydrochloride,naltrexone hydrochloride, PM: decision on the application for modification of an agreed PIP, P/0390/2021 |
|
12/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Evarrest, human fibrinogen,human thrombin, PM: decision on the application for modification of an agreed PIP, P/0397/2021 |
|
12/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Kyntheum, brodalumab, PM: decision on the application for modification of an agreed PIP, P/0386/2021 |
|
12/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Rubidium (82Rb) chloride, PM: decision on the application for modification of an agreed PIP, P/0356/2021 |
|
12/01/2023 |
Newsletter: News bulletin for small and medium-sized enterprises - Issue 57
|
|
12/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Cerdelga, Eliglustat (tartrate), PM: decision on the application for modification of an agreed PIP, P/0385/2021 |
|
11/01/2023 |
Human medicines European public assessment report (EPAR): Duaklir Genuair, aclidinium bromide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, 19/11/2014,  , 15, Authorised |
|
11/01/2023 |
Human medicines European public assessment report (EPAR): Eklira Genuair, aclidinium bromide, Pulmonary Disease, Chronic Obstructive, 20/07/2012, , 20, Authorised |
|
11/01/2023 |
Human medicines European public assessment report (EPAR): Libmyris, adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Psoriasis; Hidradenitis Suppurativa; Crohn Disease; Colitis, Ulcerative; Uveitis, 12/11/2021,  , 1, Authorised |
|
11/01/2023 |
Human medicines European public assessment report (EPAR): Toviaz, fesoterodine fumarate, Urinary Bladder, Overactive, 20/04/2007, 27, Authorised |
|
11/01/2023 |
Ninth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicine
, Online, 13:00 - 17:30 Amsterdam time (CET), from 24/11/2022 to 24/11/2022 |
|
11/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Ociperlimab, W: decision granting a waiver in all age groups for all conditions or indications, P/0354/2021 |
|
11/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): 5’-capped mRNA encoding HPV16 oncoprotein E6 and E7, W: decision granting a waiver in all age groups for all conditions or indications, P/0401/2021 |
|
11/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Azithromycin, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0381/2021 |
|
11/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Indapamide,perindopril (arginine),amlodipine,bisoprolol (fumarate), W: decision granting a waiver in all age groups for all conditions or indications, P/0366/2021 |
|
11/01/2023 |
Human medicines European public assessment report (EPAR): Protopic, tacrolimus, Dermatitis, Atopic, 27/02/2002, 26, Authorised |
|
11/01/2023 |
Other: Timetable: Post-authorisation safety study (PASS) protocols and final results
|
|
11/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): vaborbactam, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0230/2015 |
|
11/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Prednisolone, W: decision granting a waiver in all age groups for all conditions or indications, P/0376/2021 |
|
11/01/2023 |
PIP - Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision: Vaborbactam - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision
|
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11/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Prasterone,levonorgestrel,ethinylestradiol, W: decision granting a waiver in all age groups for all conditions or indications, P/0359/2021 |
|
11/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): L-Lactic acid,citric acid,potassium bitartrate, W: decision granting a waiver in all age groups for all conditions or indications, P/0378/2021 |
|
11/01/2023 |
Agenda: Agenda - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (11 January 2022)
|
|
10/01/2023 |
Human medicines European public assessment report (EPAR): Tacforius, tacrolimus monohydrate, Liver Transplantation; Kidney Transplantation, 08/12/2017,  , 7, Authorised |
|
10/01/2023 |
Newsletter: Electronic Application Form (eAF) newsletter - Issue 2
|
|
10/01/2023 |
Human medicines European public assessment report (EPAR): Kyntheum, brodalumab, Psoriasis, 17/07/2017, 6, Authorised |
|
10/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Single chain urokinase plasminogen activator (scuPA), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0391/2021 |
|
10/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Multivalent pneumococcal polysaccharide conjugate to carrier protein (SP0202), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0373/2021 |
|
10/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Efgartigimod alfa, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0392/2021 |
|
10/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Nexpovio, Selinexor, W: decision granting a waiver in all age groups for all conditions or indications, P/0364/2021 |
|
10/01/2023 |
Human medicines European public assessment report (EPAR): Amvuttra, vutrisiran sodium, Amyloid Neuropathies, Familial, 15/09/2022,  , , 1, Authorised |
|
10/01/2023 |
Minutes: CHMP PROM minutes for the meeting on 31 October 2022
|
|
10/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Concizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0371/2021 |
|
10/01/2023 |
2022 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA)
, Online, 10:30 - 16:00 Amsterdam time (CEST), from 04/10/2022 to 04/10/2022 |
|
10/01/2023 |
Agenda: CHMP PROM agenda for the meeting on 31 October 2022
|
|
10/01/2023 |
Template or form: Template for registering new active substance on EUTCT
|
|
10/01/2023 |
Agenda: Agenda of the CHMP meeting 7-10 November 2022
|
|
10/01/2023 |
Periodic safety update single assessment: Erythromycin (systemic use) - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA/00010808/202203
|
|
09/01/2023 |
Human medicines European public assessment report (EPAR): Pregabalin Accord, pregabalin, Anxiety Disorders; Epilepsy, 28/08/2015, , 15, Authorised |
|
09/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): ligelizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0372/2021 |
|
09/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): N-hydroxy-5-methylfuran-2-sulfonamide (BMS-986231), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0110/2019 |
|
09/01/2023 |
PIP - Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision: N-hydroxy-5-methylfuran-2-sulfonamide (BMS-986231) - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision
|
|
09/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Tecentriq, atezolizumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0384/2021 |
|
09/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, Baricitinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0070/2020 |
|
09/01/2023 |
PIP - Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision: Baricitinib - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision
|
|
09/01/2023 |
Agenda: Agenda of the PRAC meeting 9-12 January 2023
|
|
09/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Neuraceq, florbetaben (18F), W: decision granting a waiver in all age groups for all conditions or indications, P/0352/2021 |
|
09/01/2023 |
Other: Antimicrobial Sales and Use (ASU) data reporting protocol - Part 2 Reporting use data
|
|
09/01/2023 |
Template or form: Template - Antimicrobial Sales and Use (ASU) data reporting template - Part 2 Reporting use data
|
|
09/01/2023 |
Other: Antimicrobial Sales and Use (ASU) data reporting protocol - Part 1 Reporting volume of sales
|
|
09/01/2023 |
Template or form: Template - Antimicrobial Sales and Use (ASU) data reporting template - Part 1 Reporting volume of sales
|
|
09/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Jardiance, empagliflozin, W: decision granting a waiver in all age groups for all conditions or indications, P/0306/2021 |
|
09/01/2023 |
Newsletter: CTIS newsflash - 6 January 2023
|
|
09/01/2023 |
Periodic safety update single assessment: Erythromycin (systemic use) - List of nationally authorised medicinal products - PSUSA/00010808/202203
|
|
09/01/2023 |
Periodic safety update single assessment: Amoxicillin - List of nationally authorised medicinal products - PSUSA/00000187/202203
|
|
09/01/2023 |
Periodic safety update single assessment: Amoxicillin/clavulanate : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000188/202203
|
|
09/01/2023 |
Periodic safety update single assessment: Amoxicillin/clavulanate : List of nationally authorised medicinal products - PSUSA/00000188/202203
|
|
09/01/2023 |
Orphan designation: Humanised IgG1 monoclonal antibody against TfR1 conjugated to double stranded siRNA oligonucleotide against DMPK via a non-cleavable linker
for the: Treatment of myotonic disorders, 20/08/2021, Positive |
|
09/01/2023 |
Recruitment: Careers at European Medicines Agency (EMA) - Guidance on selection and recruitment
|
|
09/01/2023 |
Other: European Medicines Agency budget for 2023
|
|
06/01/2023 |
ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Scientific guideline |
|
06/01/2023 |
Scientific guideline: ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 5
|
|
06/01/2023 |
Notifying a change of marketing status |
|
05/01/2023 |
Good manufacturing practice |
|
05/01/2023 |
Regulatory and procedural guideline: Validation checklist for Type II (non) clinical variations
|
|
05/01/2023 |
Work programme: Consolidated 3-year work plan for the Rheumatology and Immunology Working Party (RIWP)
|
|
05/01/2023 |
Orphan designation: zanubrutinib
for the: Treatment of marginal zone lymphoma, 20/05/2021, Withdrawn |
|
05/01/2023 |
Human medicines European public assessment report (EPAR): Mvasi, bevacizumab, Carcinoma, Renal Cell; Peritoneal Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Fallopian Tube Neoplasms, 15/01/2018, , 14, Authorised |
|
05/01/2023 |
Regulatory and procedural guideline: Member states contact points for review of national translations of Quick Response (QR) codes of veterinary medicinal products authorised via the centralised, mutual recognition, decentralised procedures and national procedures
|
|
05/01/2023 |
Human medicines European public assessment report (EPAR): Ibandronic acid Accord, ibandronic acid, Wounds and Injuries; Breast Diseases; Neoplastic Processes; Calcium Metabolism Disorders; Water-Electrolyte Imbalance, 18/11/2012, , 14, Authorised |
|
05/01/2023 |
Human Variations electronic application forms Q&A Clinics – Session 1
, Online, 11:00 - 11:30 Amsterdam time (CEST), from 15/11/2022 to 15/11/2022 |
|
05/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): PEGylated-fibroblast growth factor 21 (BMS-986036), PM: decision on the application for modification of an agreed PIP, P/0346/2021 |
|
05/01/2023 |
Newsletter: CTIS newsflash - 22 December 2022
|
|
05/01/2023 |
Minutes: PDCO minutes of the 8-11 November 2022 meeting
|
|
05/01/2023 |
Other: Outcome of written procedures finalised during the period from 30 September 2022 to 5 December 2022
|
|
05/01/2023 |
Minutes: Minutes of the 117th meeting of the Management Board: 6 October 2022
|
|
05/01/2023 |
PRAC recommendation on signal: PRAC recommendations on signals adopted at the 28 November - 1 December 2022 PRAC meeting
|
|
05/01/2023 |
Human medicines European public assessment report (EPAR): Zirabev, bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms, 14/02/2019, , , 12, Authorised |
|
05/01/2023 |
Human medicines European public assessment report (EPAR): Bretaris Genuair, aclidinium bromide, Pulmonary Disease, Chronic Obstructive, 20/07/2012, , 18, Authorised |
|
04/01/2023 |
Human medicines European public assessment report (EPAR): Brimica Genuair, formoterol fumarate dihydrate, aclidinium bromide, Pulmonary Disease, Chronic Obstructive, 19/11/2014, , 13, Authorised |
|
04/01/2023 |
Periodic safety update single assessment: Fexofenadine - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA/00001388/202203
|
|
04/01/2023 |
Periodic safety update single assessment: Fexofenadine - List of nationally authorised medicinal products - PSUSA/00001388/202203
|
|
04/01/2023 |
Human medicines European public assessment report (EPAR): Viread, tenofovir disoproxil fumarate, Hepatitis B, Chronic; HIV Infections, 04/02/2002, 58, Authorised |
|
04/01/2023 |
Regulatory and procedural guideline: EudraVigilance registration documents
|
|
04/01/2023 |
Other: Policy 58: European Medicines Agency policy on the handling of competing interests of Management Board members
|
|
04/01/2023 |
Other: Policy 44: European Medicines Agency policy on the handling of competing interests of scientific committees’ members and experts
|
|
04/01/2023 |
Other: European Medicines Agency breach of trust procedure for competing interests of and disclosure of confidential information by scientific committees’ members and experts
|
|
04/01/2023 |
Other: European Medicines Agency breach of trust procedure on declarations of competing interests for Management Board members
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