|
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 |
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 |
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 |
|
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 |
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
|
|
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): 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 |
|
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 |
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): 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): Telzir, fosamprenavir calcium, HIV Infections, 12/07/2004, 48, 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 |
|
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 |
Mpox (monkeypox) |
|
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 |
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 |
|
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 |
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 |
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): 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 |
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 |
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 |
|
12/08/2022 |
Supply shortage: Visudyne (verteporfin) supply shortage
|
|
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 |
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: 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 |
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): 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: Record of data processing activity EMA IT Security Operations Centre (SOC)
|
|
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: adenovirus associated viral vector serotype 5 containing the human pde6β gene
for the: Treatment of retinitis pigmentosa, 19/06/2013, 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 |
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 |
Other: Orientation guide for industry - EMA building
|
|
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 - August 2022
, 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 |
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, , 4, 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 |
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 |
Other: Declaration of interests: Davide Prandi
|
|
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 |
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
|
|
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): Sogroya, Somapacitan, Growth, 31/03/2021, , , 1, Authorised |
