31/08/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, baricitinib, PM: decision on the application for modification of an agreed PIP, P/0311/2021 |
31/08/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Feraccru, ferric maltol, PM: decision on the application for modification of an agreed PIP, P/0316/2021 |
31/08/2022 |
Human medicines European public assessment report (EPAR): Riximyo, rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Microscopic Polyangiitis; Wegener Granulomatosis, 15/06/2017, , 11, Authorised |
31/08/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): procaine (hydrochloride),xylitol,potassium chloride,magnesium sulfate heptahydrate, PM: decision on the application for modification of an agreed PIP, P/0295/2021 |
31/08/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Heplisav B, Hepatitis B (rDNA) surface antigen adjuvanted, PM: decision on the application for modification of an agreed PIP, P/0304/2021 |
31/08/2022 |
Human medicines European public assessment report (EPAR): Rixathon, rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis; Microscopic Polyangiitis; Pemphigus, 15/06/2017, , 9, Authorised |
31/08/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Uptravi, Selexipag, PM: decision on the application for modification of an agreed PIP, P/0328/2021 |
31/08/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Exparel liposomal, bupivacaine, PM: decision on the application for modification of an agreed PIP, P/0342/2021 |
31/08/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Brintellix, Vortioxetine, PM: decision on the application for modification of an agreed PIP, P/0310/2021 |
31/08/2022 |
Human medicines European public assessment report (EPAR): Faslodex, fulvestrant, Breast Neoplasms, 09/03/2004, 23, Authorised |
31/08/2022 |
Human medicines European public assessment report (EPAR): MabThera, rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell, 02/06/1998, 57, Authorised |
31/08/2022 |
Procurement: Guidebook for tenderers (revised August 2022)
|
31/08/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Vimpat, lacosamide, PM: decision on the application for modification of an agreed PIP, P/0349/2021 |
31/08/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Entresto, sacubitril,valsartan, PM: decision on the application for modification of an agreed PIP, P/0327/2021 |
31/08/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Ocrevus, ocrelizumab, PM: decision on the application for modification of an agreed PIP, P/0305/2021 |
31/08/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): RoActemra, tocilizumab, PM: decision on the application for modification of an agreed PIP, P/0303/2021 |
31/08/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Saxenda, liraglutide, PM: decision on the application for modification of an agreed PIP, P/0309/2021 |
31/08/2022 |
Human medicines European public assessment report (EPAR): Zutectra, human hepatitis B immunoglobulin, Immunization, Passive; Hepatitis B; Liver Transplantation, 30/11/2009, 15, Authorised |
31/08/2022 |
Human medicines European public assessment report (EPAR): Emend, Aprepitant, Vomiting; Postoperative Nausea and Vomiting; Cancer, 11/11/2003, 29, Authorised |
31/08/2022 |
Human medicines European public assessment report (EPAR): Spravato, esketamine hydrochloride, Depressive Disorder, 18/12/2019, , 6, Authorised |
31/08/2022 |
Herbal medicinal product: Foeniculi amari fructus aetheroleum, Foeniculi amari fructus aetheroleum, F: Assessment finalised
|
31/08/2022 |
Human medicines European public assessment report (EPAR): Irbesartan/Hydrochlorothiazide Teva, irbesartan, hydrochlorothiazide, Hypertension, 26/11/2009, , 21, Authorised |
31/08/2022 |
Herbal medicinal product: Juniperi pseudo-fructus (galbulus), Juniperi pseudo-fructus (galbulus), F: Assessment finalised
|
30/08/2022 |
Human medicines European public assessment report (EPAR): Pioglitazone Teva Pharma, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 26/03/2012, , 13, Withdrawn |
30/08/2022 |
Human medicines European public assessment report (EPAR): Pregabalin Pfizer, pregabalin, Anxiety Disorders; Epilepsy, 10/04/2014, 28, Authorised |
30/08/2022 |
EMA regular press briefing on COVID-19 and monkeypox
, Online, 14:00 - 14:30 Amsterdam time (CEST), from 02/09/2022 to 02/09/2022 |
30/08/2022 |
Orphan designation: setanaxib
for the: Treatment of primary biliary cholangitis, 06/01/2021, Positive |
30/08/2022 |
Orphan designation: 2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H-pyrazolo[4,3-C]pyridine-3,6(2H,5H)-dione
for the: Treatment of systemic sclerosis, 09/10/2015, Positive |
30/08/2022 |
Orphan designation: 2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H-pyrazolo[4,3-C]pyridine-3,6(2H,5H)-dione
for the: Treatment of idiopathic pulmonary fibrosis, 26/11/2010, Positive |
30/08/2022 |
Orphan designation: Sirolimus
for the: Treatment of chronic non-infectious uveitis, 30/08/2011, Withdrawn |
30/08/2022 |
Orphan designation: Human monoclonal antibody against human interleukin 13
for the: Treatment of eosinophilic oesophagitis, 13/11/2013, Withdrawn |
30/08/2022 |
Herbal medicinal product: Trigonellae foenugraeci semen, Trigonellae foenugraeci semen, F: Assessment finalised
|
30/08/2022 |
Human medicines European public assessment report (EPAR): Viagra, sildenafil, Erectile Dysfunction, 13/09/1998, 42, Authorised |
29/08/2022 |
Agenda: Agenda of the PRAC meeting 29 August - 1 September 2022
|
29/08/2022 |
Human medicines European public assessment report (EPAR): Ziagen, abacavir, HIV Infections, 08/07/1999, 46, Authorised |
29/08/2022 |
Human medicines European public assessment report (EPAR): Epivir, lamivudine, HIV Infections, 08/08/1996, 50, Authorised |
29/08/2022 |
Human medicines European public assessment report (EPAR): Combivir, lamivudine, zidovudine, HIV Infections, 18/03/1998, 37, Authorised |
26/08/2022 |
Human medicines European public assessment report (EPAR): Ivemend, fosaprepitant, Vomiting; Cancer, 11/01/2008, 24, Authorised |
26/08/2022 |
Human medicines European public assessment report (EPAR): Bydureon, exenatide, Diabetes Mellitus, Type 2, 17/06/2011, 23, Authorised |
26/08/2022 |
Human medicines European public assessment report (EPAR): Aripiprazole Zentiva, aripiprazole, Schizophrenia; Bipolar Disorder, 25/06/2015, , 9, Authorised |
26/08/2022 |
Human medicines European public assessment report (EPAR): Wegovy , semaglutide, Obesity; Overweight, 06/01/2022, , 2, Authorised |
26/08/2022 |
Human medicines European public assessment report (EPAR): Synflorix, Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19F, Pneumococcal Infections; Immunization, 29/03/2009, 34, Authorised |
25/08/2022 |
Human medicines European public assessment report (EPAR): Ontilyv, opicapone, Parkinson Disease, 21/02/2022, 1, Authorised |
25/08/2022 |
Human medicines European public assessment report (EPAR): Sunlenca, Lenacapavir sodium, HIV Infections, 17/08/2022, , Authorised |
25/08/2022 |
Human medicines European public assessment report (EPAR): Daxas, roflumilast, Pulmonary Disease, Chronic Obstructive, 05/07/2010, , 19, Authorised |
25/08/2022 |
Human medicines European public assessment report (EPAR): Pemetrexed Krka, pemetrexed disodium, Carcinoma, Non-Small-Cell Lung; Mesothelioma, 22/05/2018, , 5, Authorised |
25/08/2022 |
Human medicines European public assessment report (EPAR): Byetta, exenatide, Diabetes Mellitus, Type 2, 20/11/2006, 27, Authorised |
25/08/2022 |
Human medicines European public assessment report (EPAR): Revatio, sildenafil, Hypertension, Pulmonary, 28/10/2005, 48, Authorised |
25/08/2022 |
Human medicines European public assessment report (EPAR): Lyrica, pregabalin, Epilepsy; Anxiety Disorders; Neuralgia, 05/07/2004, 58, Authorised |
25/08/2022 |
Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, 14/01/2019, , 8, Authorised |
25/08/2022 |
Human medicines European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma), Lonapegsomatropin, Growth and Development, 11/01/2022, , , 1, Authorised |
25/08/2022 |
EPAR - Scientific conclusion: Spikevax (previously COVID-19 Vaccine Moderna)-H-C-PSUSA-00010897-202112: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
|
24/08/2022 |
Signal management |
24/08/2022 |
Human medicines European public assessment report (EPAR): Tecentriq, atezolizumab, Carcinoma, Transitional Cell; Carcinoma, Non-Small-Cell Lung; Urologic Neoplasms; Breast Neoplasms; Small Cell Lung Carcinoma, 20/09/2017, 20, Authorised |
24/08/2022 |
Human medicines European public assessment report (EPAR): Actelsar HCT, telmisartan, hydrochlorothiazide, Essential Hypertension, 13/03/2013, , 14, Authorised |
24/08/2022 |
Human medicines European public assessment report (EPAR): Opatanol, olopatadine hydrochloride, Conjunctivitis, Allergic, 16/05/2002, 23, Authorised |
24/08/2022 |
ICH Q14 Analytical procedure development - Scientific guideline |
24/08/2022 |
ICH Q2(R2) Validation of analytical procedures - Scientific guideline |
23/08/2022 |
Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 1 September 2022
, Online, from 01/09/2022 to 01/09/2022 |
23/08/2022 |
Report: Key performance indicators (KPIs) to monitor the European clinical trials environment (1 – 31 July 2022, edition 4)
|
23/08/2022 |
Human medicines European public assessment report (EPAR): Nordimet, Methotrexate, Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid, 18/08/2016, 17, Authorised |
23/08/2022 |
Human medicines European public assessment report (EPAR): Maviret, glecaprevir, pibrentasvir, Hepatitis C, Chronic, 26/07/2017, , 17, Authorised |
23/08/2022 |
Human medicines European public assessment report (EPAR): Telzir, fosamprenavir calcium, HIV Infections, 12/07/2004, 48, Authorised |
23/08/2022 |
Human medicines European public assessment report (EPAR): Constella, linaclotide, Irritable Bowel Syndrome, 26/11/2012, 24, Authorised |
23/08/2022 |
Human medicines European public assessment report (EPAR): Kivexa, abacavir, lamivudine, HIV Infections, 16/12/2004, 36, Authorised |
23/08/2022 |
Human medicines European public assessment report (EPAR): Aptivus, tipranavir, HIV Infections, 25/10/2005, 42, Authorised |
23/08/2022 |
Human medicines European public assessment report (EPAR): Viramune, nevirapine, HIV Infections, 04/02/1998, 43, Authorised |
22/08/2022 |
Orphan designation: Melphalan flufenamide
for the: Treatment of plasma cell myeloma, 19/03/2015, Withdrawn |
22/08/2022 |
Human medicines European public assessment report (EPAR): Rukobia, fostemsavir trometamol, HIV Infections, 04/02/2021, , 3, Authorised |
22/08/2022 |
Human medicines European public assessment report (EPAR): Celsentri, maraviroc, HIV Infections, 18/09/2007, 28, Authorised |
22/08/2022 |
Human medicines European public assessment report (EPAR): Ivabradine Zentiva, ivabradine hydrochloride, Angina Pectoris; Heart Failure, 11/11/2016, , 5, Authorised |
22/08/2022 |
Human medicines European public assessment report (EPAR): Sovaldi, Sofosbuvir, Hepatitis C, Chronic, 16/01/2014, , 26, Authorised |
22/08/2022 |
Other: List of critical medicines for Monkeypox public health emergency (PHE) under Regulation (EU) 2022/123
|
22/08/2022 |
Mpox (monkeypox) |
22/08/2022 |
Crisis preparedness and management |
22/08/2022 |
Human medicines European public assessment report (EPAR): Cuprior, Trientine tetrahydrochloride, Hepatolenticular Degeneration, 05/09/2017, 6, Authorised |
22/08/2022 |
Human medicines European public assessment report (EPAR): Forxiga, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic, 11/11/2012, 26, Authorised |
22/08/2022 |
Regulatory and procedural guideline: PRIME eligibility requests: 2023 deadlines for submission and timetable for assessment
|
22/08/2022 |
Report: Medicinal products for human use: monthly figures - July 2022
|
19/08/2022 |
News and press releases: EMA’s Emergency Task Force advises on intradermal use of Imvanex / Jynneos against monkeypox |
19/08/2022 |
Human medicines European public assessment report (EPAR): Luxturna, voretigene neparvovec, Leber Congenital Amaurosis; Retinitis Pigmentosa, 22/11/2018, , , 5, Authorised |
19/08/2022 |
Eighth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicine
, Online, from 27/06/2022 to 27/06/2022 |
19/08/2022 |
Human medicines European public assessment report (EPAR): Leqvio, inclisiran, Hypercholesterolemia; Dyslipidemias, 09/12/2020, , 4, Authorised |
19/08/2022 |
Buying veterinary medicines online |
19/08/2022 |
Human medicines European public assessment report (EPAR): Yselty, linzagolix choline, Leiomyoma, 14/06/2022, , 1, Authorised |
18/08/2022 |
News and press releases: EMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccine |
18/08/2022 |
Minutes: Minutes of the CHMP meeting 20-23 June 2022
|
18/08/2022 |
Committee for Medicinal Products for Human Use (CHMP): 20-23 June 2022
, European Medicines Agency, Amsterdam, the Netherlands, from 20/06/2022 to 23/06/2022 |
17/08/2022 |
Human medicines European public assessment report (EPAR): Pergoveris, follitropin alfa, lutropin alfa, Infertility, Female, 25/06/2007, 14, Authorised |
17/08/2022 |
Orphan designation: autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo
for the: Treatment of ovarian cancer, 16/04/2018, Withdrawn |
17/08/2022 |
Human medicines European public assessment report (EPAR): Dynastat, parecoxib sodium, Pain, Postoperative, 22/03/2002, 32, Authorised |
17/08/2022 |
Human medicines European public assessment report (EPAR): Ciambra, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma, 02/12/2015, , 6, Authorised |
16/08/2022 |
Human medicines European public assessment report (EPAR): Duloxetine Zentiva, duloxetine, Neuralgia; Depressive Disorder, Major; Anxiety Disorders; Diabetes Mellitus, 20/08/2015, , 11, Authorised |
16/08/2022 |
Human medicines European public assessment report (EPAR): Zynquista, Sotagliflozin, Diabetes Mellitus, Type 1, 26/04/2019, , 3, Withdrawn |
16/08/2022 |
Human medicines European public assessment report (EPAR): Brineura, cerliponase alfa, Neuronal Ceroid-Lipofuscinoses, 30/05/2017, , , , , 6, Authorised |
16/08/2022 |
Human medicines European public assessment report (EPAR): HBVaxPro, hepatitis B, recombinant surface antigen, Hepatitis B; Immunization, 27/04/2001, 32, Authorised |
16/08/2022 |
Human medicines European public assessment report (EPAR): RotaTeq, rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1, Immunization; Rotavirus Infections, 26/06/2006, 34, Authorised |
16/08/2022 |
Agenda: Agenda of the CHMP written procedure 16-19 August 2022
|
12/08/2022 |
Minutes: CHMP PROM minutes for the meeting on 13 June 2022
|
12/08/2022 |
Agenda: CHMP PROM agenda for the meeting on 13 June 2022
|
12/08/2022 |
Committee for Medicinal Products for Human Use (CHMP): 16-19 May 2022
, European Medicines Agency, Amsterdam, the Netherlands, from 16/05/2022 to 19/05/2022 |
12/08/2022 |
Minutes: CHMP PROM agenda for the meeting on 10 May 2022
|
12/08/2022 |
Human medicines European public assessment report (EPAR): Exviera, dasabuvir sodium, Hepatitis C, Chronic, 14/01/2015, , 25, Authorised |
12/08/2022 |
Human medicines European public assessment report (EPAR): Viekirax, Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic, 14/01/2015, 27, Authorised |
12/08/2022 |
Human medicines European public assessment report (EPAR): Sifrol, pramipexole dihydrochloride monohydrate, Restless Legs Syndrome; Parkinson Disease, 13/10/1997, 36, Authorised |
12/08/2022 |
Orphan designation: Recombinant truncated N-terminal fragment of human lens epithelium-derived growth factor
for the: Treatment of retinitis pigmentosa, 23/08/2017, Withdrawn |
12/08/2022 |
Other: EVVet3 EVWeb Production – Release notes (Release 1.6)
|
12/08/2022 |
Human medicines European public assessment report (EPAR): Mirapexin, pramipexole dihydrochloride monohydrate, Restless Legs Syndrome; Parkinson Disease, 23/02/1998, 39, Authorised |
12/08/2022 |
Minutes: CHMP PROM minutes for the meeting on 11 April 2022
|
12/08/2022 |
COVID-19 treatments: authorised |
12/08/2022 |
Agenda: CHMP PROM agenda for the meeting on 11 April 2022
|
12/08/2022 |
Minutes: CHMP PROM minutes for the meeting on 14 March 2022
|
12/08/2022 |
Agenda: CHMP PROM agenda for the meeting on 14 March 2022
|
12/08/2022 |
Other: European Medicines Agency budget for 2022
|
12/08/2022 |
Supply shortage: Visudyne (verteporfin) supply shortage
|
12/08/2022 |
Direct healthcare professional communication (DHPC): Visudyne (verteporfin): Information on the continuing supply limitation until end of 2023, Active substance: verteporfin, DHPC type: Medicine shortage, Last updated: 12/08/2022 |
11/08/2022 |
Work programme: CHMP work plan 2022
|
11/08/2022 |
Human medicines European public assessment report (EPAR): Ranexa (previously Latixa), ranolazine, Angina Pectoris, 08/07/2008, 22, Authorised |
11/08/2022 |
Direct animal healthcare professional communications |
11/08/2022 |
News and press releases: EMA business hours over Assumption Day, 15 August |
11/08/2022 |
Direct healthcare professional communication (DHPC): Hiprabovis IBR Marker Live (infectious bovine rhinotracheitis vaccine (live)) - Increase in the incidence of anaphylactic-type reactions in cattle, Active substance: live gE- tk- double-gene-deleted bovine herpes virus type 1, strain CEDDEL: 106.3–107.3 CCID50, DHPC type: Adverse event, Last updated: 11/08/2022 |
10/08/2022 |
Orphan designation: allogeneic peripheral blood mononuclear cells incubated ex-vivo with 16, 16-dimethyl prostaglandin E2, dexamethasone
for the: Treatment in haematopoietic stem cell transplantation, 18/11/2016, Withdrawn |
10/08/2022 |
Human medicines European public assessment report (EPAR): Grasustek, pegfilgrastim, Neutropenia, 20/06/2019, , , 3, Authorised |
10/08/2022 |
Human medicines European public assessment report (EPAR): Gliolan, 5-aminolevulinic acid hydrochloride, Glioma, 07/09/2007, 7, Authorised |
10/08/2022 |
Recruitment: Decision of the Executive Director on rules governing the traineeship programme at the EMA
|
10/08/2022 |
Supply shortage: Cetrotide (cetrorelix acetate) supply shortage
|
10/08/2022 |
Committee meeting report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 18-20 July 2022
|
10/08/2022 |
Herbal medicinal product: Paulliniae semen, Paulliniae semen, F: Assessment finalised
|
10/08/2022 |
Herbal medicinal product: Origani dictamni herba, Origani dictamni herba, F: Assessment finalised
|
10/08/2022 |
Orphan designation: N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide (ivacaftor)
for the: Treatment of cystic fibrosis, 08/07/2008, Expired |
10/08/2022 |
Herbal medicinal product: Hyperici herba and Cimicifugae rhizoma, Hyperici herba,Cimicifugae rhizoma, D: Draft under discussion
|
10/08/2022 |
Herbal medicinal product: Liquiritiae radix, Liquiritiae radix, F: Assessment finalised
|
10/08/2022 |
Herbal medicinal product: Lichen islandicus, Lichen islandicus, F: Assessment finalised
|
10/08/2022 |
Herbal medicinal product: Cnici benedicti herba, Cnici benedicti herba, D: Draft under discussion
|
10/08/2022 |
Opinion/decision on a Paediatric investigation plan (PIP): Elafibranor, W: decision granting a waiver in all age groups for all conditions or indications, P/0295/2020 |
10/08/2022 |
Orphan designation: 2-Chloro-N6-(3-iodobenzyl)adenosine-5'-N-methyluronamide (namodenoson)
for the: Treatment of hepatocellular carcinoma, 09/10/2015, Positive |
09/08/2022 |
Human medicines European public assessment report (EPAR): Adenuric, febuxostat, Gout, 21/04/2008, 22, Authorised |
09/08/2022 |
Human medicines European public assessment report (EPAR): Pemetrexed medac, pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma, 26/11/2015, , 8, Authorised |
09/08/2022 |
Agenda: Agenda - EMA IRIS industry training for GVP Inspections
|
09/08/2022 |
Other: Orientation guide for patient representatives and healthcare professionals - EMA building
|
09/08/2022 |
Other: Orientation guide for industry - EMA building
|
09/08/2022 |
Other: Record of data processing activity EMA IT Security Operations Centre (SOC)
|
09/08/2022 |
Human medicines European public assessment report (EPAR): Zejula, Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms, 16/11/2017, , , 18, Authorised |
09/08/2022 |
Orphan designation: Adenovirus associated viral vector serotype 4 containing the human RPE65 gene
for the: Treatment of retinitis pigmentosa, 14/11/2007, Positive |
09/08/2022 |
Orphan designation: Adenovirus associated viral vector serotype 4 containing the human RPE65 gene
for the: Treatment of Leber's congenital amaurosis, 22/10/2007, Positive |
09/08/2022 |
Orphan designation: Adeno-associated viral vector serotype 5 containing the human RLBP1 gene
for the: Treatment of retinitis pigmentosa, 14/10/2016, Positive |
09/08/2022 |
Orphan designation: adenovirus associated viral vector serotype 5 containing the human pde6β gene
for the: Treatment of retinitis pigmentosa, 19/06/2013, Positive |
09/08/2022 |
Direct healthcare professional communication (DHPC): Cetrorelix acetate - Cetrotide 0.25 mg Powder and solvent for injection: Temporary Shortage, Active substance: cetrorelix (as acetate), DHPC type: Medicine shortage, Last updated: 09/08/2022 |
09/08/2022 |
Referral: Daruph and Anafezyn
, dasatinib (anhydrous), Article 29(4) referrals, European Commission final decision, 19/05/2022, 18/07/2022, 09/08/2022 |
09/08/2022 |
Human medicines European public assessment report (EPAR): Signifor, pasireotide, Acromegaly; Pituitary ACTH Hypersecretion, 24/04/2012, , 14, Authorised |
09/08/2022 |
Template or form: Step 2 - No nitrosamine detected response template
|
08/08/2022 |
Human medicines European public assessment report (EPAR): Thymanax, Agomelatine, Depressive Disorder, Major, 19/02/2009, 18/11/2006, 24, Authorised |
08/08/2022 |
COVID-19 guidance: research and development |
08/08/2022 |
Herbal medicinal product: Saccharomyces cerevisiae CBS 5926, Saccharomyces cerevisiae CBS 5926, F: Assessment finalised
|
08/08/2022 |
Human medicines European public assessment report (EPAR): Valdoxan, Agomelatine, Depressive Disorder, Major, 19/02/2009, 24, Authorised |
08/08/2022 |
Direct healthcare professional communication (DHPC): Rubraca (rucaparib): restriction of indication, Active substance: rucaparib camsylate, DHPC type: Referral - Article 20 procedure, Restriction of indication, Last updated: 08/08/2022 |
06/08/2022 |
Newsletter: Big Data highlights - Issue 3
|
05/08/2022 |
Human medicines European public assessment report (EPAR): Braftovi, Encorafenib, Melanoma; Colorectal Neoplasms, 19/09/2018, , 10, Authorised |
04/08/2022 |
Human medicines European public assessment report (EPAR): Myclausen, mycophenolate mofetil, Graft Rejection, 07/10/2010, , 15, Authorised |
04/08/2022 |
Human medicines European public assessment report (EPAR): Topotecan Hospira, topotecan, Uterine Cervical Neoplasms; Small Cell Lung Carcinoma, 09/06/2010, 19, Authorised |
04/08/2022 |
Human medicines European public assessment report (EPAR): Ervebo, recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola, 11/11/2019, , 7, Authorised |
03/08/2022 |
Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel besilate, Peripheral Vascular Diseases; Stroke; Myocardial Infarction, 16/10/2009, , 26, Authorised |
03/08/2022 |
Other: EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines
|
03/08/2022 |
COVID-19 vaccine safety update: COVID-19 vaccines - Safety update: 14 July 2022
|
03/08/2022 |
Herbal medicinal product: Salviae miltiorrhizae rhizoma, Salviae miltiorrhizae radix et rhizoma, F: Assessment finalised
|
03/08/2022 |
Clinical Trials Information System (CTIS): Walk-in clinic
, Online, 16:00 - 16:45 Amsterdam time (CEST), from 31/08/2022 to 31/08/2022 |
03/08/2022 |
Seventh Nitrosamine Implementation Oversight Group (NIOG) meeting
, Online, from 14/07/2022 to 14/07/2022 |
03/08/2022 |
Minutes: Highlights from the seventh Nitrosamine Implementation Oversight Group (NIOG) meeting
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03/08/2022 |
Orphan designation: Mazindol
for the: Treatment of narcolepsy, 09/10/2015, Positive |
02/08/2022 |
Minutes: PCDO minutes of the 21-24 June 2022 meeting
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02/08/2022 |
Clinical Trials Information System (CTIS) bitesize talk: Transitional trials and additional Member State concerned (MSC) application
, Online, 14:00 - 15:30 Amsterdam time (CEST), from 23/06/2022 to 23/06/2022 |
02/08/2022 |
European Medicines Agency (EMA) and Federation of Veterinarians of Europe (FVE) webinar on the Union Product Database website
, Online, 11:30-13:00 Amsterdam time (CEST), from 27/06/2022 to 27/06/2022 |
02/08/2022 |
Human medicines European public assessment report (EPAR): Cosentyx, Secukinumab, Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing, 14/01/2015, 27, Authorised |
02/08/2022 |
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Information session: Industry webinar
, Online, 10:30 - 12:30 Amsterdam time (CEST), from 15/09/2022 to 15/09/2022 |
02/08/2022 |
Introduction to Organisation Management Service (OMS): Industry webinar
, Online, 14:30 - 16:30 Amsterdam time (CEST), from 15/09/2022 to 15/09/2022 |
02/08/2022 |
Introduction to Referentials Management Service (RMS): Industry webinar
, Online, 10:30 - 12:30 Amsterdam time (CEST), from 21/09/2022 to 21/09/2022 |
02/08/2022 |
Introduction to Substance Management Service (SMS): Industry webinar
, Online, 10:30 - 12:30 Amsterdam time (CEST), from 06/09/2022 to 06/09/2022 |
02/08/2022 |
Newsletter: News bulletin for small and medium-sized enterprises - Issue 56
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02/08/2022 |
Human medicines European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan, acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome; Myocardial Infarction, 09/01/2020, , 4, Authorised |
02/08/2022 |
Human medicines European public assessment report (EPAR): Nexviadyme, Avalglucosidase alfa, Glycogen Storage Disease Type II, 24/06/2022, , Authorised |
02/08/2022 |
Orphan designation: Recombinant human alpha-glucosidase conjugated with multiple copies of synthetic bismannose-6-phosphate-tetra-mannose glycan (avalglucosidase alfa)
for the: Treatment of glycogen storage disease type II (Pompe's disease), 26/03/2014, Withdrawn |
02/08/2022 |
Orphan designation: Pegylated recombinant arginine deiminase (pegargiminase)
for the: Treatment of malignant mesothelioma, 15/01/2015, Positive |
02/08/2022 |
Human medicines European public assessment report (EPAR): Bonviva, ibandronic acid, Osteoporosis, Postmenopausal, 23/02/2004, 29, Authorised |
02/08/2022 |
EPAR - Scientific conclusion: Bonviva-H-C-PSUSA-00001702-202106 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
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02/08/2022 |
Pharmacovigilance Risk Assessment Committee (PRAC): 25-28 October 2021
, European Medicines Agency, Amsterdam, the Netherlands, from 25/10/2021 to 28/10/2021 |
02/08/2022 |
Minutes: Minutes of the PRAC meeting 25-28 October 2021
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02/08/2022 |
Digital application dataset integration (DADI) Q&A webinar - variations form for human medicinal products
, Online, 11:00 - 12:30 Amsterdam time (CEST), from 12/07/2022 to 12/07/2022 |
01/08/2022 |
Human medicines European public assessment report (EPAR): Zokinvy, Lonafarnib, Progeria; Laminopathies, 18/07/2022, , , , Authorised |
01/08/2022 |
Periodic safety update single assessment: Dexketoprofen : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00000997/202110
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01/08/2022 |
Periodic safety update single assessment: Dexketoprofen : List of nationally authorised medicinal products - PSUSA/00000997/202110
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01/08/2022 |
Human medicines European public assessment report (EPAR): Fluenz Tetra, A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444, Influenza, Human, 04/12/2013, 22, Authorised |
01/08/2022 |
Other: Declaration of interests: Davide Prandi
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01/08/2022 |
Human medicines European public assessment report (EPAR): Flucelvax Tetra, A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human, 12/12/2018, , 11, Authorised |
01/08/2022 |
Regulatory and procedural guideline: Draft report on the development of a harmonised approach to exposure assessment methodologies for residues from veterinary medicinal products, feed additives and pesticides residues in food of animal origin
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01/08/2022 |
Human medicines European public assessment report (EPAR): Okedi, Risperidone, Schizophrenia, 14/02/2022, 1, Authorised |
01/08/2022 |
Withdrawn application: Aduhelm, aducanumab, Date of withdrawal: 20/04/2022, Initial authorisation |
01/08/2022 |
Human medicines European public assessment report (EPAR): Strimvelis, autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency, 26/05/2016, , , 8, Authorised |
01/08/2022 |
PRAC recommendation on signal: PRAC recommendations on signals adopted at the 4-7 July 2022 PRAC meeting
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01/08/2022 |
Periodic safety update single assessment: Soybean phospholipids (oral use) : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00010707/202110
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01/08/2022 |
Periodic safety update single assessment: Soybean phospholipids (oral use) : List of nationally authorised medicinal products - PSUSA/00010707/202110
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01/08/2022 |
Regulatory and procedural guideline: Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 August 2022
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01/08/2022 |
Other: Explanatory note on general fees payable to the European Medicines Agency as of 01 August 2022
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01/08/2022 |
Human medicines European public assessment report (EPAR): Vosevi, Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic, 26/07/2017, 13, Authorised |
01/08/2022 |
Human medicines European public assessment report (EPAR): Sogroya, Somapacitan, Growth, 31/03/2021, , , 1, Authorised |