News & events

What's new

RSS
Jan 2023 (478) Dec 2022 (408) Nov 2022 (417) Oct 2022 (290) Sep 2022 (314) Aug 2022 (204) Jul 2022 (298) Jun 2022 (380) May 2022 (236) Apr 2022 (263) Mar 2022 (293) Feb 2022 (282) Jan 2022 (5)
Date Content
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, Biosimilar, 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, Biosimilar, 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, Additional monitoring, 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, Generic, 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, Generic, 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, Generic, 9, Authorised
26/08/2022 Human medicines European public assessment report (EPAR): Wegovy , semaglutide, Obesity; Overweight, 06/01/2022, Additional monitoring, 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, Additional monitoring, Authorised
25/08/2022 Human medicines European public assessment report (EPAR): Daxas, roflumilast, Pulmonary Disease, Chronic Obstructive, 05/07/2010, Additional monitoring, 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, Generic, 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, Additional monitoring, 8, Authorised
25/08/2022 Human medicines European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma), Lonapegsomatropin, Growth and Development, 11/01/2022, Orphan, Additional monitoring, 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, Generic, 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, Accelerated assessment, 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, Additional monitoring, 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, Generic, 5, Authorised
22/08/2022 Human medicines European public assessment report (EPAR): Sovaldi, Sofosbuvir, Hepatitis C, Chronic, 16/01/2014, Accelerated assessment, 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, Orphan, Additional monitoring, 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, Additional monitoring, 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, Additional monitoring, 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, Generic, 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, Generic, 11, Authorised
16/08/2022 Human medicines European public assessment report (EPAR): Zynquista, Sotagliflozin, Diabetes Mellitus, Type 1, 26/04/2019, Additional monitoring, 3, Withdrawn
16/08/2022 Human medicines European public assessment report (EPAR): Brineura, cerliponase alfa, Neuronal Ceroid-Lipofuscinoses, 30/05/2017, Orphan, Accelerated assessment, Additional monitoring, Exceptional circumstances, 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, Accelerated assessment, 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, Additional monitoring, Biosimilar, 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, Generic, 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, Orphan, Additional monitoring, 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, Orphan, 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, Additional monitoring, 10, Authorised
04/08/2022 Human medicines European public assessment report (EPAR): Myclausen, mycophenolate mofetil, Graft Rejection, 07/10/2010, Generic, 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, Additional monitoring, 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, Generic, 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
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
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
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, Generic, 4, Authorised
02/08/2022 Human medicines European public assessment report (EPAR): Nexviadyme, Avalglucosidase alfa, Glycogen Storage Disease Type II, 24/06/2022, Additional monitoring, 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)
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
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, Orphan, Additional monitoring, Exceptional circumstances, 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
01/08/2022 Periodic safety update single assessment: Dexketoprofen : List of nationally authorised medicinal products - PSUSA/00000997/202110
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
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, Additional monitoring, 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
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, Orphan, Additional monitoring, 8, Authorised
01/08/2022 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 4-7 July 2022 PRAC meeting
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
01/08/2022 Periodic safety update single assessment: Soybean phospholipids (oral use) : List of nationally authorised medicinal products - PSUSA/00010707/202110
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
01/08/2022 Other: Explanatory note on general fees payable to the European Medicines Agency as of 01 August 2022
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, Orphan, Additional monitoring, 1, Authorised