|
31/01/2023 |
Regulatory and procedural guideline: Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency (EMA) and to members of the Committee for Medicinal Products for Veterinary use (CVMP)
|
|
31/01/2023 |
Human medicines European public assessment report (EPAR): Mayzent, Siponimod fumaric acid, Multiple Sclerosis, Relapsing-Remitting, 13/01/2020,  , 9, Authorised |
|
31/01/2023 |
Clinical Trials Information System (CTIS): Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023
, Online, 10:00 - 13:00 Amsterdam time (CET), from 20/01/2023 to 20/01/2023 |
|
31/01/2023 |
Human medicines European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma), Lonapegsomatropin, Growth and Development, 11/01/2022,  , , 3, Authorised |
|
31/01/2023 |
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 |
|
31/01/2023 |
Minutes: Minutes of the HMPC 21-23 November 2022 meeting
|
|
31/01/2023 |
EMA virtual workshop on myocarditis post COVID-19 vaccination
, Online, from 16/01/2023 to 16/01/2023 |
|
31/01/2023 |
Agenda: Agenda - EMA virtual workshop on myocarditis post COVID-19 vaccination
|
|
31/01/2023 |
Human medicines European public assessment report (EPAR): Efficib, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 15/07/2008, 32, Authorised |
|
31/01/2023 |
Union Product Database: release notes |
|
31/01/2023 |
Periodic safety update single assessment: Methoxyflurane : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010484/202205
|
|
31/01/2023 |
Periodic safety update single assessment: Methoxyflurane : List of nationally authorised medicinal products - PSUSA/00010484/202205
|
|
31/01/2023 |
Human medicines European public assessment report (EPAR): Truxima, rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Wegener Granulomatosis; Leukemia, Lymphocytic, Chronic, B-Cell; Microscopic Polyangiitis, 17/02/2017,  , 19, Authorised |
|
31/01/2023 |
Human medicines European public assessment report (EPAR): Xelevia, sitagliptin, Diabetes Mellitus, Type 2, 21/03/2007, 37, Authorised |
|
31/01/2023 |
Work programme: Work plan for the joint CHMP/ CVMP Quality Working Party (QWP) for 2023
|
|
31/01/2023 |
News and press releases: Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU |
|
31/01/2023 |
Report: Annual accounts: Financial year 2021
|
|
31/01/2023 |
Report: Key performance indicators (KPIs) to monitor the European clinical trials environment (1-31 December 2022, edition 9)
|
|
31/01/2023 |
Report: Final programming document 2023-2025
|
|
30/01/2023 |
Orphan designation: Allogeneic Epstein-Barr virus specific cytotoxic T lymphocytes (Tabelecleucel)
for the: Treatment of post-transplantation lymphoproliferative disorders, 21/03/2016, Positive |
|
30/01/2023 |
Orphan designation: Ex-vivo-expanded autologous keratinocytes transduced with retroviral vector containing the COL7A1 gene (prademagene zamikeracel)
for the: Treatment of epidermolysis bullosa, 27/02/2017, Positive |
|
30/01/2023 |
Periodic safety update single assessment: Bleomycin - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000422/202203
|
|
30/01/2023 |
Periodic safety update single assessment: Bleomycin : List of nationally authorised medicinal products - PSUSA/00000422/202203
|
|
30/01/2023 |
Other: Clinical Trials Information System (CTIS) common features - CTIS Training Programme - Module 02
|
|
30/01/2023 |
Minutes: CHMP PROM minutes for the meeting on 5 December 2022
|
|
30/01/2023 |
Agenda: CHMP PROM agenda for the meeting on 5 December 2022
|
|
30/01/2023 |
Human medicines European public assessment report (EPAR): Liprolog, insulin lispro, Diabetes Mellitus, 01/08/2001, 30, Authorised |
|
30/01/2023 |
Human medicines European public assessment report (EPAR): Tecartus, Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel), Lymphoma, Mantle-Cell, 14/12/2020, , ,  , 4, Authorised |
|
30/01/2023 |
EPAR - Assessment report - Variation: Synflorix-H-C-973-P46-0072 : EPAR - Assessment Report - Variation
|
|
30/01/2023 |
Human medicines European public assessment report (EPAR): Menveo, meningococcal group A, C, W-135 and Y conjugate vaccine, Immunization; Meningitis, Meningococcal, 15/03/2010, 17/12/2009, 32, Authorised |
|
30/01/2023 |
Withdrawn application: Febseltiq, infigratinib, Date of withdrawal: 11/10/2022, Initial authorisation |
|
30/01/2023 |
EPAR - Assessment report - Variation: Menveo-H-C-1095-P46-45 : EPAR - Assessment Report - Variation
|
|
30/01/2023 |
Orphan designation: Bardoxolone methyl
for the: Treatment of autosomal dominant polycystic kidney disease, 20/08/2021, Positive |
|
30/01/2023 |
Orphan designation: Omaveloxolone
for the: Treatment of Friedreich’s ataxia, 27/06/2018, Positive |
|
30/01/2023 |
Orphan designation: Bardoxolone methyl
for the: Treatment of Alport syndrome, 25/05/2018, Positive |
|
30/01/2023 |
Orphan designation: Rilonacept
for the: Treatment of idiopathic pericarditis, 06/01/2021, Positive |
|
30/01/2023 |
Human medicines European public assessment report (EPAR): Yescarta, Axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse, 23/08/2018, , , 11, Authorised |
|
30/01/2023 |
Human medicines European public assessment report (EPAR): Optruma, raloxifene hydrochloride, Osteoporosis, Postmenopausal, 05/08/1998, 26, Authorised |
|
30/01/2023 |
Human medicines European public assessment report (EPAR): Ranivisio, ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications, 25/08/2022, , , 2, Authorised |
|
30/01/2023 |
Human medicines European public assessment report (EPAR): Yuflyma, adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid, 11/02/2021, , 9, Authorised |
|
30/01/2023 |
Human medicines European public assessment report (EPAR): Rybrevant, amivantamab, Carcinoma, Non-Small-Cell Lung, 09/12/2021, , , 2, Authorised |
|
27/01/2023 |
Clinical Trials Information System (CTIS): online modular training programme |
|
27/01/2023 |
Work programme: PRAC work plan 2023
|
|
27/01/2023 |
Orphan designation: idursulfase
for the: Treatment of mucopolysaccharidosis type II (Hunter's syndrome), 06/01/2021, Withdrawn |
|
27/01/2023 |
Minutes: CHMP PROM minutes for the meeting on 10 May 2022
|
|
27/01/2023 |
Other: Question and answer document on the Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products (EMA/CVMP/SWP/377245/2016)
|
|
27/01/2023 |
News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023 |
|
27/01/2023 |
Withdrawn application: Imbruvica, ibrutinib, Date of withdrawal: 13/12/2022, Post-authorisation |
|
27/01/2023 |
Summary of opinion: Trecondi, treosulfan, 26/01/2023, Positive |
|
27/01/2023 |
Summary of opinion: Sitagliptin / Metformin hydrochloride Sun, sitagliptin, metformin hydrochloride, 26/01/2023, Positive |
|
27/01/2023 |
Summary of opinion: Tolvaptan Accord, tolvaptan, 26/01/2023, Positive |
|
27/01/2023 |
Quality, safety and efficacy of bacteriophages as veterinary medicines - Scientific guideline |
|
27/01/2023 |
Scientific guideline: Guideline on quality, safety and efficacy of veterinary 5 medicinal products specifically designed for phage 6 therapy
|
|
27/01/2023 |
Overview of comments: Overview of comments received on the ‘Reflection paper on resistance in ectoparasites’ (EMA/CVMP/EWP/310225/2014)
|
|
27/01/2023 |
Scientific guideline: Reflection paper on resistance in ectoparasites
|
|
27/01/2023 |
Procedural advice for vaccine platform technology master file (vPTMF) certification - Procedural Guidance |
|
27/01/2023 |
Scientific guideline: Procedural advice for vaccine platform technology master file (vPTMF) certification
|
|
27/01/2023 |
Work programme: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Immunologicals Working Party (IWP) 2023
|
|
27/01/2023 |
Guidance for the application of Article 34 of Regulation (EU) 2019/6 - prescription status |
|
27/01/2023 |
Overview of comments: Overview of comments received on CVMP guideline on NVR Art 34 for the classification of VMPs
|
|
27/01/2023 |
Regulatory and procedural guideline: Guideline on the application of Article 34 of Regulation (EU) 2019/6
|
|
27/01/2023 |
Regulatory and procedural guideline: Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin
|
|
27/01/2023 |
Work programme: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Safety Working Party (SWP-V) 2023
|
|
26/01/2023 |
News and press releases: EMA Committee for Advanced Therapies elects Ilona Reischl as its new Chair |
|
26/01/2023 |
Supply shortage: Pazenir (paclitaxel) supply shortage
|
|
26/01/2023 |
Human Variations electronic application forms Q&A Clinics – Session 3 (focus: access management)
, Online, 11:00 - 11:30 Amsterdam time (CET), from 29/11/2022 to 29/11/2022 |
|
26/01/2023 |
Orphan designation: Loncastuximab tesirine
for the: Treatment of diffuse large B-cell lymphoma, 20/08/2021, Withdrawn |
|
26/01/2023 |
Other: Letter of Support for Braintale platforms
|
|
26/01/2023 |
Work programme: 2022-2025 Work plan for the Patients’ and Consumers’ Working Party (PCWP) and the Healthcare Professionals’ Working Party (HCPWP)
|
|
26/01/2023 |
Human Variations electronic application forms Q&A Clinics – Session 2
, Online, 11:00 - 11:30 Amsterdam time (CEST), from 22/11/2022 to 22/11/2022 |
|
26/01/2023 |
Other: Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA)
|
|
26/01/2023 |
Periodic safety update single assessment: Triptorelin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003048/202203
|
|
26/01/2023 |
Periodic safety update single assessment: Triptorelin : List of nationally authorised medicinal products - PSUSA/00003048/202203
|
|
26/01/2023 |
Other: FAQs: Transition of trials from EudraCT to CTIS - CTIS Training Programme - Module 23
|
|
26/01/2023 |
Other: Sponsors' guide: Transition of trials from EudraCT to CTIS - CTIS Training Programme - Module 23
|
|
26/01/2023 |
Other: Member states' guide: Transition of trials from EudraCT to CTIS - CTIS Training Programme - Module 23
|
|
26/01/2023 |
Other: Clinical Trial Information System (CTIS) evaluation timelines
|
|
26/01/2023 |
Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) |
|
25/01/2023 |
Human medicines European public assessment report (EPAR): Coagadex, Human coagulation factor X, Factor X Deficiency, 16/03/2016, ,  , 9, Authorised |
|
25/01/2023 |
Withdrawn application: Versiguard SARS CoV2, Recombinant SARS CoV2 spike protein, Date of withdrawal: 15/09/2022, Initial authorisation |
|
25/01/2023 |
Eligible patients and consumers organisations |
|
25/01/2023 |
Direct healthcare professional communication (DHPC): Pazenir® (paclitaxel formulated as albumin bound nanoparticles) 5 mg/ml powder for dispersion for infusion: temporary supply shortage, Active substance: paclitaxel, DHPC type: Medicine shortage, Last updated: 25/01/2023 |
|
25/01/2023 |
EPAR - Assessment report - Variation: Bexsero-H-C-2333-P46-031 : EPAR - Assessment Report - Variation
|
|
25/01/2023 |
Human medicines European public assessment report (EPAR): Tabrecta, capmatinib dihydrochloride monohydrate, Carcinoma, Non-Small-Cell Lung, 20/06/2022, , 1, Authorised |
|
25/01/2023 |
Other: Statement on the amended policy on orphan designations for inherited retinal dystrophies
|
|
25/01/2023 |
Organisation Management System (OMS) Trouble Shooting Session for CTIS users - November 2022
, Online, 14:00 - 15:00 Amsterdam time (CEST), from 24/11/2022 to 24/11/2022 |
|
25/01/2023 |
Human medicines European public assessment report (EPAR): Dexmedetomidine Accord, dexmedetomidine, Premedication, 13/02/2020,  , 6, Authorised |
|
25/01/2023 |
Orphan designation: propagermanium
for the: Treatment of focal segmental glomerulosclerosis, 19/11/2018, Positive |
|
25/01/2023 |
Template or form: Request to the CVMP for classification of a veterinary medicinal product as intended for a limited market according to Article 4(29) and for eligibility for authorisation according to Article 23 (Applications for limited markets)
|
|
25/01/2023 |
Orphan designation: 2,4,6,7,8,9-hexahydro-4-((2-methylphenyl)methyl)-7-(phenylmethyl)imidazo(1,2-a)pyrido(3,4-e)pyrimidin-5(1H)-one
for the: Treatment of glioma, 18/07/2022, Positive |
|
25/01/2023 |
Other: Record of data processing activity for reporting fraud and irregularities (public)
|
|
25/01/2023 |
Human medicines European public assessment report (EPAR): Lacosamide UCB, lacosamide, Epilepsies, Partial, 26/08/2019, 5, Authorised |
|
25/01/2023 |
Orphan designation: Humanised IgG4 monoclonal antibody against active complement component 1, subcomponent s
for the: Treatment of autoimmune haemolytic anaemia, 18/07/2022, Positive |
|
25/01/2023 |
Human medicines European public assessment report (EPAR): Besremi, ropeginterferon alfa-2b, Polycythemia Vera, 15/02/2019, , 4, Authorised |
|
25/01/2023 |
Orphan designation: zilucoplan
for the: Treatment of myasthenia gravis, 18/07/2022, Positive |
|
25/01/2023 |
Other: European Medicines Agency’s data protection notice for the procedure for handling and reporting internally potential fraud and irregularities
|
|
25/01/2023 |
Orphan designation: Odronextamab
for the: Treatment of follicular lymphoma, 18/07/2022, Positive |
|
25/01/2023 |
Orphan designation: Odronextamab
for the: Treatment of diffuse large B-cell lymphoma, 18/07/2022, Positive |
|
25/01/2023 |
Human medicines European public assessment report (EPAR): Trecondi, Treosulfan, Hematopoietic Stem Cell Transplantation, 20/06/2019, 3, Authorised |
|
25/01/2023 |
Orphan designation: Adeno-associated viral vector serotype 9 containing the human ABCD1 gene
for the: Treatment of adrenoleukodystrophy, 11/11/2022, Positive |
|
25/01/2023 |
Human medicines European public assessment report (EPAR): Oncaspar, pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/01/2016, 16, Authorised |
|
25/01/2023 |
Orphan designation: Autologous naive regulatory T cells transduced with a lentiviral vector encoding for a chimeric antigen receptor to recognise the HLA-A*02 antigen
for the: Treatment in solid organ transplantation, 18/07/2022, Positive |
|
24/01/2023 |
Safety of COVID-19 vaccines |
|
24/01/2023 |
Supply shortage: Shortage of Insuman Rapid, Basal and Comb 25 (insulin human)
|
|
24/01/2023 |
Presentation: Lanreotide : List of nationally authorised medicinal products - PSUSA/00001826/202205
|
|
24/01/2023 |
Periodic safety update single assessment: Vinorelbine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003124/202204
|
|
24/01/2023 |
Periodic safety update single assessment: Vinorelbine : List of nationally authorised medicinal products - PSUSA/00003124/202204
|
|
24/01/2023 |
Orphan designation: Recombinant human mesencephalic astrocyte-derived neurotrophic factor
for the: Treatment of retinitis pigmentosa, 24/04/2015, Positive |
|
24/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Selumetinib, PM: decision on the application for modification of an agreed PIP, P/0341/2021 |
|
24/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, PM: decision on the application for modification of an agreed PIP, P/0400/2018 |
|
23/01/2023 |
Orphan designation: (R)-deuteropioglitazone hydrochloride
for the: Treatment of adrenoleukodystrophy, 11/11/2022, Positive |
|
23/01/2023 |
Orphan designation: (S)-5-(1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethylamino-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile (olutasidenib)
for the: Treatment of acute myeloid leukaemia, 29/05/2019, Positive |
|
23/01/2023 |
Periodic safety update single assessment: Aprotinin / calcium chloride / human factor xiii / human fibrinogen / human thrombin, aprotinin / fibrinogen / fibronectin / human coagulation factor XIII / ... - List of nationally authorised medicinal products - PSUSA/00010346/202111
|
|
23/01/2023 |
Orphan designation: tricaprilin
for the: Treatment of West syndrome, 11/11/2022, Positive |
|
23/01/2023 |
Periodic safety update single assessment: Fentanyl (transdermal patches, solution for injection - nationally authorised product only) - CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001370/202204
|
|
23/01/2023 |
Periodic safety update single assessment: Fentanyl (transdermal patches, solution for injection - nationally authorised product only) - List of nationally authorised medicinal products - PSUSA/00001370/202204
|
|
23/01/2023 |
Orphan designation: Refusal of orphan designation for the treatment of retinopathy of prematurity
, 28/11/2022, Negative |
|
23/01/2023 |
Orphan designation: Pegcetacoplan
for the: Treatment of C3 glomerulopathy with or without immune complexes, 11/11/2022, Positive |
|
23/01/2023 |
Orphan designation: Adeno-associated virus serotype 5 vector encoding C1-esterase inhibitor
for the: Treatment of hereditary angioedema, 10/11/2022, Positive |
|
23/01/2023 |
Orphan designation: N-(4-(4-amino-5-(3-fluoro-4-((4-methylpyrimidin-2-yl)oxy)phenyl)-7-methyl-7H-pyrrolo[2,3-d] pyrimidin-6-yl)phenyl)methacrylamide hydrochloride
for the: Treatment of biliary tract cancer, 10/11/2022, Positive |
|
23/01/2023 |
Orphan designation: Iodine (124I) evuzamitide
for the: Diagnosis of AL amyloidosis, 11/11/2022, Positive |
|
23/01/2023 |
Orphan designation: Copper nanocluster conjugated to acetate, histidinate and ascorbate
for the: Treatment of Menkes disease, 11/11/2022, Positive |
|
23/01/2023 |
Orphan designation: Delpazolid
for the: Treatment of tuberculosis, 10/11/2022, Positive |
|
23/01/2023 |
Orphan designation: rovatirelin
for the: Treatment of spinocerebellar ataxia, 11/11/2022, Positive |
|
23/01/2023 |
Orphan designation: atorvastatin
for the: Treatment of familial cerebral cavernous malformations, 11/11/2022, Positive |
|
23/01/2023 |
Orphan designation: Thiostrepton
for the: Treatment of malignant mesothelioma, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: Propranolol
for the: Treatment of familial cerebral cavernous malformations, 11/11/2022, Positive |
|
23/01/2023 |
Human medicines European public assessment report (EPAR): Envarsus, tacrolimus, Graft Rejection, 18/07/2014, 12, Authorised |
|
23/01/2023 |
Orphan designation: (R)-3-(2,3-dihydroxypropyl)-6-fluoro-5-(2-fluoro-4-iodophenylamino)-8-methylpyrido[2,3-d]pyrimidine-4,7(3H,8H)-dione
for the: Treatment of familial adenomatous polyposis (FAP), 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: Toripalimab
for the: Treatment of nasopharyngeal cancer, 18/07/2022, Withdrawn |
|
23/01/2023 |
Clinical Trials Information System (CTIS): Walk-in clinic - November 2022
, Online, 16:00 - 16:45 Amsterdam time (CEST), from 15/11/2022 to 15/11/2022 |
|
23/01/2023 |
Orphan designation: erlotinib
for the: Treatment of pachyonychia congenita, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: Fosmanogepix
for the: Treatment of invasive candidiasis, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: liraglutide
for the: Treatment of Wolfram syndrome, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: Fosmanogepix
for the: Treatment of invasive aspergillosis, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: mRNA encoding modified human ornithine transcarbamylase
for the: Treatment of ornithine transcarbamylase deficiency, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: W253R/R275S tissue plasminogen activator
for the: Treatment of non-traumatic spontaneous intracerebral haemorrhage, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: Pyridoxal 5'-phosphate
for the: Treatment of pyridoxal 5'‐phosphate homeostasis protein deficiency, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: Hydroquinidine hydrochloride
for the: Treatment of Brugada syndrome, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: 3-(1,3-benzodioxol-5-yl)-5-(3-bromophenyl)-1H-pyrazole
for the: Treatment of multiple system atrophy, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: Human decorin fused to the truncated homing peptide CRK
for the: Treatment of epidermolysis bullosa, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: Refusal of orphan designation for the prevention of spaceflight-related radiation and microgravity
, 14/10/2022, Negative |
|
23/01/2023 |
Orphan designation: Sodium phenylbutyrate
for the: Treatment of maple syrup urine disease, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: (S)-1-(4-(1-(3,4,5-trimethoxyphenyl)-1H-imidazol-4-ylamino)thieno[2,3-d]pyrimidin-2-yl)pyrrolidine-2-carboxamide
for the: Treatment of fibrodysplasia ossificans progressiva, 18/07/2022, Positive |
|
23/01/2023 |
Human medicines European public assessment report (EPAR): Metalyse, tenecteplase, Myocardial Infarction, 23/02/2001, 22, Authorised |
|
23/01/2023 |
Orphan designation: Vilobelimab
for the: Treatment of pyoderma gangrenosum, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: Efgartigimod alfa
for the: Treatment of pemphigus, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: Panobinostat
for the: Treatment of glioma, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: Parsaclisib
for the: Treatment of autoimmune haemolytic anaemia, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: Heterologous swine glyco-humanised polyclonal antibody against T lymphocytes
for the: Treatment in solid organ transplantation, 18/07/2022, Positive |
|
23/01/2023 |
Orphan designation: Salmonella enterica, subsp. enterica, serovar Typhimurium, strain YS1646, live
for the: Treatment of schwannoma, 18/07/2022, Positive |
|
23/01/2023 |
Periodic safety update single assessment: Ivermectin (systemic use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010377/202204
|
|
23/01/2023 |
Periodic safety update single assessment: Ivermectin (systemic use) : List of nationally authorised medicinal products - PSUSA/00010377/202204
|
|
23/01/2023 |
Other: Extension of reserve lists for external selection procedures: Contract Agent reserve list
|
|
23/01/2023 |
Other: Extension of reserve lists for external selection procedures: Temporary Agent reserve lists
|
|
23/01/2023 |
Agenda: Agenda of the CHMP meeting 23-26 January 2023
|
|
23/01/2023 |
Human medicines European public assessment report (EPAR): Omnitrope, somatropin, Turner Syndrome; Prader-Willi Syndrome; Dwarfism, Pituitary, 12/04/2006, , 21, Authorised |
|
23/01/2023 |
Periodic safety update single assessment: Lamivudine / tenofovir disoproxil : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010751/202203
|
|
23/01/2023 |
Periodic safety update single assessment: Lamivudine / tenofovir disoproxil : List of nationally authorised medicinal products - PSUSA/00010751/202203
|
|
23/01/2023 |
Human medicines European public assessment report (EPAR): Filsuvez, dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w), Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional, 21/06/2022, , 1, Authorised |
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23/01/2023 |
Newsletter: CTIS newsflash – 20 January 2023
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23/01/2023 |
Human medicines European public assessment report (EPAR): Trepulmix, Treprostinil sodium, Hypertension, Pulmonary, 03/04/2020, , 3, Authorised |
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23/01/2023 |
Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances
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23/01/2023 |
Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations
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20/01/2023 |
How to pay |
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20/01/2023 |
Template or form: PRAC D94 Rapporteur RMP assessment report template rev. 01.23
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20/01/2023 |
Other: New Organization First User QPPV/RP or Change of EU QPPV/RP
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20/01/2023 |
Template or form: Day 150 or Day 195 joint response assessment report - Overview and list of outstanding issues template - Rev. 01.23
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20/01/2023 |
Template or form: Day 80 assessment report - Clinical template with guidance - Rev. 01 23
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20/01/2023 |
Periodic safety update single assessment: Omeprazole : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002215/202204
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20/01/2023 |
Periodic safety update single assessment: Omeprazole : List of nationally authorised medicinal products - PSUSA/00002215/202204
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20/01/2023 |
Periodic safety update single assessment: Cefuroxime sodium (except for intracameral use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000615/202204
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20/01/2023 |
Periodic safety update single assessment: Cefuroxime sodium (except for intracameral use) : List of nationally authorised medicinal products - PSUSA/00000615/202204
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20/01/2023 |
Periodic safety update single assessment: Tolperisone : List of nationally authorised medicinal products - PSUSA/00002991/202206
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20/01/2023 |
Paediatric Committee (PDCO) |
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20/01/2023 |
News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 17-18 January 2023 |
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20/01/2023 |
News and press releases: Joint statement by Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on shortages of antibiotic medicines |
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20/01/2023 |
Referral: Amfepramone-containing medicinal products
, amfepramone, Regenon,Tenuate Retard,Amfepramon-Hormosan,Regenon Retard, Article 31 referrals, European Commission final decision, 10/11/2022, 13/01/2023, 20/01/2023 |
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20/01/2023 |
Minutes: Minutes of the COMP meeting 8-10 November 2022
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20/01/2023 |
Periodic safety update single assessment: Cefuroxime axetil - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA/00009099/202204
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20/01/2023 |
Periodic safety update single assessment: Cefuroxime axetil - List of nationally authorised medicinal products - PSUSA/00009099/202204
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20/01/2023 |
Changing the name or address of a sponsor |
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20/01/2023 |
Template or form: EudraVigilance Form A
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19/01/2023 |
Periodic safety update single assessment: Olsalazine - List of nationally authorised medicinal products - PSUSA/00002213/202205
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19/01/2023 |
Human medicines European public assessment report (EPAR): Xofluza, Baloxavir marboxil, Influenza, Human, 07/01/2021, , 4, Authorised |
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19/01/2023 |
European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties meeting with all eligible organisations
, Online, from 15/11/2022 to 15/11/2022 |
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19/01/2023 |
Template or form: Application form for European Medicines Agency certificates of medicinal products
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19/01/2023 |
Periodic safety update single assessment: Latanoprost / timolol - List of nationally authorised medicinal products - PSUSA/00001833/202206
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19/01/2023 |
Human medicines European public assessment report (EPAR): Pemetrexed Baxter, pemetrexed disodium heptahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma, 09/12/2022, , Authorised |
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19/01/2023 |
News and press releases: Assessment of human dietary exposure to residues of veterinary medicines in the EU |
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19/01/2023 |
Report: EMA / EFSA report on development of a harmonised approach to human dietary exposure
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19/01/2023 |
Overview of comments: Overview of comments received on draft EMA / EFSA report on development of a harmonised approach to human dietary exposure
|
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19/01/2023 |
News and press releases: Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications |
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19/01/2023 |
Periodic safety update single assessment: Valsartan, hydrochlorothiazide / valsartan - List of nationally authorised medicinal products - PSUSA/00010396/202204
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19/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): (14S)-8-[3-(2-{dispiro[2.0.2^(4).1^(3)]heptan-7-yl}ethoxy)-1H-pyrazol-1-yl]-12,12-dimethyl- 2lambda^(6)-thia-3,9,11,18,23-penta-azatetracyclo[17.3.1.1^(11,14).0^(5,10)]tetracosa- 1(22),5,7,9,19(23),20-hexaene-2,2,4-trione calcium salt hydrate / tezacaftor / deutivacaftor (VX-121/ TEZ/D-IVA), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0071/2022 |
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18/01/2023 |
Periodic safety update single assessment: Eprosartan - List of nationally authorised medicinal products - PSUSA/00001243/202204
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18/01/2023 |
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, , 11, Authorised |
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18/01/2023 |
Periodic safety update single assessment: Eprosartan hydrochlorothiazide - List of nationally authorised medicinal products - PSUSA/00001244/202204
|
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18/01/2023 |
Newsletter: Human medicines highlights - January 2023
|
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18/01/2023 |
Periodic safety update single assessment: Tirofiban : List of nationally authorised medicinal products - PSUSA/00002974/202205
|
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18/01/2023 |
Human medicines European public assessment report (EPAR): Stelara, Ustekinumab, Psoriasis; Arthritis, Psoriatic; Crohn Disease; Colitis, Ulcerative, 15/01/2009, 42, Authorised |
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18/01/2023 |
Human medicines European public assessment report (EPAR): Praxbind, idarucizumab, Hemorrhage, 20/11/2015, , 11, Authorised |
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18/01/2023 |
Human medicines European public assessment report (EPAR): Lysodren, Mitotane, Adrenal Cortex Neoplasms, 28/04/2004, 18, Authorised |
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18/01/2023 |
Human medicines European public assessment report (EPAR): Avonex, interferon beta-1a, Multiple Sclerosis, 13/03/1997, 36, Authorised |
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18/01/2023 |
Regulatory and procedural guideline: Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe: Introduction - EU Implementation Guide
|
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18/01/2023 |
Regulatory and procedural guideline: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 7
|
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18/01/2023 |
Report: Big Data Steering Group (BDSG): 2022 report
|
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17/01/2023 |
Agenda: Agenda of the PDCO meeting 17-20 January 2023
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17/01/2023 |
Minutes: Minutes of the CHMP meeting 7-10 November 2022
|
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17/01/2023 |
Human medicines European public assessment report (EPAR): Cresemba, isavuconazole, Aspergillosis, 15/10/2015, , 15, Authorised |
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17/01/2023 |
Human medicines European public assessment report (EPAR): Instanyl, Fentanyl citrate, Pain; Cancer, 20/07/2009, 35, Authorised |
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17/01/2023 |
Human medicines European public assessment report (EPAR): Suboxone, buprenorphine, naloxone, Opioid-Related Disorders, 26/09/2006, 21, Authorised |
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17/01/2023 |
Periodic safety update single assessment: Calcifediol - List of nationally authorised medicinal products - PSUSA/00000491/202206
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17/01/2023 |
Human medicines European public assessment report (EPAR): Olanzapine Mylan, olanzapine, Schizophrenia; Bipolar Disorder, 06/10/2008, , 18, Authorised |
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17/01/2023 |
Periodic safety update single assessment: Alteplase - List of nationally authorised medicinal products - PSUSA/00000112/202205
|
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17/01/2023 |
Human medicines European public assessment report (EPAR): Oprymea, pramipexole dihydrochloride monohydrate, Parkinson Disease, 12/09/2008, , 22, Authorised |
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17/01/2023 |
Orphan designation: Ramiprilat
for the: Treatment of Stargardt's disease, 12/03/2013, Positive |
|
17/01/2023 |
Orphan designation: Herpes simplex virus 1 expressing the human CFTR gene
for the: Treatment of cystic fibrosis, 26/03/2021, Positive |
|
17/01/2023 |
Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib (as phosphate), Myeloproliferative Disorders; Polycythemia Vera; Graft vs Host Disease, 23/08/2012, 27, Authorised |
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16/01/2023 |
Certification of medicinal products |
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16/01/2023 |
Human medicines European public assessment report (EPAR): Kengrexal, cangrelor, Acute Coronary Syndrome; Vascular Surgical Procedures, 23/03/2015, , 15, Authorised |
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16/01/2023 |
Human medicines European public assessment report (EPAR): Atriance, nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, 22/08/2007, ,  , 26, Authorised |
|
16/01/2023 |
Human medicines European public assessment report (EPAR): Hycamtin, topotecan, Ovarian Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma, 12/11/1996, 38, Authorised |
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16/01/2023 |
Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal, 15/04/2005, 31, Authorised |
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16/01/2023 |
Other: DARWIN EU data partners onboarded in phase I
|
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16/01/2023 |
Human medicines European public assessment report (EPAR): Levodopa/Carbidopa/Entacapone Orion, levodopa, carbidopa, entacapone, Parkinson Disease, 23/08/2011, 13, Authorised |
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16/01/2023 |
Other: Implementation of the new WHO certificate template – compilation of changes
|
|
16/01/2023 |
Other: Information package for certificates of medicinal products issued by the European Medicines Agency
|
|
16/01/2023 |
Regulatory and procedural guideline: Information note on the format and validity features of electronic certificates for medicines issued by the European Medicines Agency
|
|
16/01/2023 |
Regulatory and procedural guideline: European Medicines Agency certificates of medicinal products - instructions on how to fill in the application form
|
|
16/01/2023 |
Human medicines European public assessment report (EPAR): Koselugo, Selumetinib sulfate, Neurofibromatosis 1, 17/06/2021, , , , 4, Authorised |
|
16/01/2023 |
Direct healthcare professional communication (DHPC): INSUMAN RAPID / INSUMAN BASAL / INSUMAN COMB 25 (insulin human): temporary supply shortage <and marketing cessation>, Active substance: insulin human, DHPC type: Medicine shortage, Last updated: 16/01/2023 |
|
16/01/2023 |
Human medicines European public assessment report (EPAR): Dimethyl fumarate Polpharma, dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting, 13/05/2022, , 3, Authorised |
|
16/01/2023 |
Other: Online verification system for electronic certificates issued by European Medicines Agency
|
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16/01/2023 |
Human medicines European public assessment report (EPAR): Cabazitaxel Accord, cabazitaxel, Prostatic Neoplasms, Castration-Resistant, 28/08/2020, , 3, Authorised |
|
16/01/2023 |
Human medicines European public assessment report (EPAR): Kaftrio, ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis, 21/08/2020, , , 11, Authorised |
|
16/01/2023 |
Human medicines European public assessment report (EPAR): Extavia, interferon beta-1b, Multiple Sclerosis, 20/05/2008, 25, Authorised |
|
16/01/2023 |
Human medicines European public assessment report (EPAR): Teriflunomide Mylan, Teriflunomide, Multiple Sclerosis, Relapsing-Remitting, 09/11/2022, , 1, Authorised |
|
16/01/2023 |
Human medicines European public assessment report (EPAR): Idefirix, Imlifidase, Desensitization, Immunologic; Kidney Transplantation, 25/08/2020, , , , 3, Authorised |
|
16/01/2023 |
Human medicines European public assessment report (EPAR): Trogarzo, Ibalizumab, HIV Infections, 26/09/2019, , 7, Withdrawn |
|
16/01/2023 |
Human medicines European public assessment report (EPAR): Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz), levodopa, carbidopa, entacapone, Parkinson Disease, 11/11/2013, 10, Authorised |
|
16/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Trogarzo, Ibalizumab, PM: decision on the application for modification of an agreed PIP, P/0248/2021 |
|
13/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Autologous tumour-infiltrating lymphocytes (LN-144/LN-145), PM: decision on the application for modification of an agreed PIP, P/0363/2021 |
|
13/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Retsevmo, Selpercatinib, PM: decision on the application for modification of an agreed PIP, P/0398/2021 |
|
13/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Narsoplimab, PM: decision on the application for modification of an agreed PIP, P/0370/2021 |
|
13/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Berotralstat, PM: decision on the application for modification of an agreed PIP, P/0353/2021 |
|
13/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): fidanacogene elaparvovec, PM: decision on the application for modification of an agreed PIP, P/0382/2021 |
|
13/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Pneumococcal Polyssacharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate,Pneumococcal Polyssacharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, PM: decision on the application for modification of an agreed PIP, P/0380/2021 |
|
13/01/2023 |
Opinion/decision on a Paediatric investigation plan (PIP): Rezafungin acetate, PM: decision on the application for modification of an agreed PIP, P/0395/2021 |
|
13/01/2023 |
Newsletter: CTIS newsflash – 13 January 2023
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