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28/02/2022 Human medicines European public assessment report (EPAR): Tandemact, pioglitazone, glimepiride, Diabetes Mellitus, Type 2, 08/01/2007, 20, Authorised
28/02/2022 Orphan designation: 3-pentylbenzeneacetic acid sodium salt for the: Treatment of idiopathic pulmonary fibrosis, 09/10/2015, Withdrawn
28/02/2022 Orphan designation: 3-pentylbenzeneacetic acid sodium salt for the: Treatment of Alström syndrome, 12/01/2017, Withdrawn
28/02/2022 Human medicines European public assessment report (EPAR): Vivanza, vardenafil, Erectile Dysfunction, 04/03/2003, 28, Withdrawn
28/02/2022 Orphan designation: N-methyl-4-({4-[({3-methyl(methylsulfonyl)aminopyrazin-2-yl}methyl)amino]-5-(trifluoromethyl)pyrimidin-2-yl}amino)benzamide hydrochloride (defactinib) for the: Treatment of malignant mesothelioma, 07/06/2013, Withdrawn
28/02/2022 Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against p53 mRNA (teprasiran) for the: Prevention of delayed graft function after renal transplantation, 06/06/2010, Withdrawn
28/02/2022 Orphan designation: Donor T lymphocytes depleted ex vivo of host alloreactive T cells using photodynamic treatment- for the: Treatment in haematopoietic stem cell transplantation, 27/06/2016, Withdrawn
28/02/2022 Orphan designation: Donor T lymphocytes depleted ex-vivo of host alloreactive T cells using photodynamic treatment for the: Treatment of acute myeloid leukaemia, 19/11/2014, Withdrawn
28/02/2022 Orphan designation: Donor lymphocyte preparation depleted of functional alloreactive T-cells for the: Prevention of graft-versus-host disease, 05/09/2008, Withdrawn
28/02/2022 Orphan designation: Allogeneic peripheral blood mononuclear cells induced to an early apoptotic state for the: Prevention of graft-versus-host disease, 15/01/2015, Withdrawn
28/02/2022 Human medicines European public assessment report (EPAR): Effentora, fentanyl, Pain; Cancer, 04/04/2008, 27, Authorised
28/02/2022 Human medicines European public assessment report (EPAR): Jylamvo, Methotrexate, Arthritis, Psoriatic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Psoriasis; Arthritis, Rheumatoid; Arthritis, 29/03/2017, 10, Authorised
25/02/2022 EMA regular press briefing on COVID-19 , Online, from 03/03/2022 to 03/03/2022
25/02/2022 Human medicines European public assessment report (EPAR): Tolucombi, telmisartan, hydrochlorothiazide, Hypertension, 13/03/2013, Generic, 10, Authorised
25/02/2022 Human medicines European public assessment report (EPAR): Oxlumo, Lumasiran sodium, Hyperoxaluria, Primary, 19/11/2020, Orphan, Additional monitoring, 2, Authorised
25/02/2022 Orphan designation: Adeno-associated virus serotype PTC3 expressing the human UBE3A gene for the: Treatment of Angelman syndrome, 20/08/2021, Positive
25/02/2022 Human medicines European public assessment report (EPAR): Bexsero, outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254), recombinant Neisseria meningitidis group B fHbp fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B NHBA fusion protein, Meningitis, Meningococcal, 13/01/2013, 29, Authorised
25/02/2022 Orphan designation: Talquetamab for the: Treatment of multiple myeloma, 20/08/2021, Positive
25/02/2022 Orphan designation: Adeno-associated viral vector serotype 9 containing the human MECP2 gene for the: Treatment of Rett syndrome, 20/08/2021, Positive
25/02/2022 Orphan designation: Human keratinocytes for the: Treatment of partial deep dermal and full thickness burns, 20/08/2021, Positive
25/02/2022 Orphan designation: Adeno-associated viral vector serotype 9 containing the human HEXA and HEXB genes for the: Treatment of GM2 gangliosidosis, 20/08/2021, Positive
25/02/2022 Orphan designation: Bardoxolone methyl for the: Treatment of autosomal dominant polycystic kidney disease, 20/08/2021, Positive
25/02/2022 Human medicines European public assessment report (EPAR): Zykadia, ceritinib, Carcinoma, Non-Small-Cell Lung, 06/05/2015, 18, Authorised
25/02/2022 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 2022
25/02/2022 News and press releases: New medicine for rare type of eye cancer
25/02/2022 Report: Medicinal products for human use: monthly figures - January 2022
25/02/2022 Agenda: Agenda - PDCO agenda of the 22-25 February 2022 meeting
25/02/2022 Orphan designation: Pro-Pro-Thr-Val-Pro-Thr-Arg for the: Treatment of xeroderma pigmentosum, 19/11/2014, Withdrawn
25/02/2022 Human medicines European public assessment report (EPAR): Rivaroxaban Mylan, rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation, 12/11/2021, Generic, Authorised
25/02/2022 Orphan designation: 5-fluoro-4-(7'-fluoro-2'-methylspiro[cyclopentane-1,3'-indol]-5'-yl)-N-(5-(1-methylpiperidin-4-yl)pyridin-2-yl)pyrimidin-2-amine for the: Treatment of glioma, 26/03/2021, Positive
25/02/2022 Interpretation of Article 18(7) of Regulation (EU) 2019/6
25/02/2022 Orphan designation: Dinaciclib for the: Treatment of chronic lymphocytic leukaemia, 27/09/2011, Withdrawn
25/02/2022 Criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation 2019/6
25/02/2022 Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro (Angiotensin 1-7) for the: Treatment of epidermolysis bullosa, 20/06/2017, Positive
25/02/2022 Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro (Angiotensin 1-7) for the: Treatment of Duchenne muscular dystrophy, 19/02/2014, Positive
25/02/2022 Regulatory and procedural guideline: Procedural advice – extended assessment time for initial marketing authorisation applications of 90 days
25/02/2022 Human medicines European public assessment report (EPAR): Micardis, telmisartan, Hypertension, 16/12/1998, 26, Authorised
24/02/2022 Minutes: Minutes of the CVMP meeting of 18-19 January 2022
24/02/2022 Introducing DADI: webinar on the digital application dataset integration (DADI) network project to replace electronic application forms , Online, 10:30 - 12:00 Amsterdam time (CET), from 18/01/2022 to 18/01/2022
24/02/2022 News and press releases: EMA recommends authorisation of booster doses of Comirnaty from 12 years of age
24/02/2022 News and press releases: EMA recommends approval of Spikevax for children aged 6 to 11
24/02/2022 EPAR - Public assessment report: Paxlovid : EPAR - Public assessment report
24/02/2022 Other: European Medicines Agency's Data Protection Notice concerning the Multistakeholder Workshop on EMA extended mandate on 1 April 2022
24/02/2022 Human medicines European public assessment report (EPAR): Voxzogo, Vosoritide, Achondroplasia, 26/08/2021, Orphan, Additional monitoring, 1, Authorised
24/02/2022 Orphan designation: Adeno-associated virus serotype 5 containing the human NR2E3 gene for the: Treatment of Leber's congenital amaurosis, 19/02/2021, Positive
23/02/2022 Human medicines European public assessment report (EPAR): Feraccru, ferric maltol, Anemia, Iron-Deficiency, 18/02/2016, 16, Authorised
23/02/2022 Orphan designation: Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Arg-Cys-Asp-Met-Ala-Glu-His-Thr-Glu-Arg-Leu-Lys-Ala-Asn-Asp-Ser-Leu-Lys-Leu-Ser-Gln-Glu-Tyr-Glu-Ser-Ile-NH2 for the: Treatment of spinal cord injury, 19/02/2021, Positive
23/02/2022 Agenda: Agenda - Third European Medicines Agency and Association of the European Self-Medication Industry (AESGP) annual bilateral meeting
23/02/2022 Third European Medicines Agency and Association of the European Self-Medication Industry (AESGP) annual bilateral meeting , Online, from 14/02/2022 to 14/02/2022
23/02/2022 Orphan designation: 2-[6-(6,7-Dimethoxyquinolin-3-yl)pyridin-3-yl]-N-[3-(1,1,1-trifluoro-2-methylpropan-2-yl)-1,2-oxazol-5-yl]acetamide for the: Treatment of medullary thyroid carcinoma, 19/02/2021, Positive
23/02/2022 Orphan designation: Dodecyl creatine ester, dodecyl creatine ester hydrochloride for the: Treatment of creatine deficiency syndromes, 19/02/2021, Positive
23/02/2022 Orphan designation: Adeno-associated virus serotype 5 containing the human NR2E3 gene for the: Treatment of retinitis pigmentosa, 19/02/2021, Positive
23/02/2022 Orphan designation: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human claudin 18.2 antigen with CD28 and CD3-zeta intracellular signalling domains for the: Treatment of gastric cancer, 19/02/2021, Positive
23/02/2022 Agenda: CHMP PROM agenda for the meeting on 17 January 2022
23/02/2022 Minutes: CHMP PROM minutes for the meeting on 17 January 2022
23/02/2022 Other: Example files - production release version 1.5.4 February 2022 - Veterinary Medicinal Products Regulation: Union Product Database
23/02/2022 DARWIN EU: multi-stakeholder information webinar , Online, 10:30 - 12:00 Amsterdam time (CET), from 24/02/2022 to 24/02/2022
23/02/2022 Newsletter: CTIS newsflash - 18 February 2022
22/02/2022 Other: Release notes - production release version 1.5.4 February 2022 - Veterinary Medicinal Products Regulation: Union Product Database
22/02/2022 Orphan designation: (2S)-2-[(2S)-4-cyclohexyl-2-{[(2S)-1-(4-fluorobenzoyl)pyrrolidin-2-yl]formamido}butanamido]-N-(1-{[(1S)-1-{[(1S)-1-({1-[(1-{[2-({1-[(dimethylamino)methyl]cyclobutyl}carbamoyl)ethyl]carbamoyl}-1-methylethyl)carbamoyl]-1-methylethyl}carbamoyl)-3-methylbutyl]carbamoyl}-3-methylbutyl]carbamoyl}-1-methylethyl)-4-methylpentanamide acetate for the: Treatment of leishmaniasis, 19/02/2021, Positive
22/02/2022 Orphan designation: Rintatolimod for the: Treatment of pancreatic cancer, 19/02/2022, Positive
22/02/2022 Human medicines European public assessment report (EPAR): Noxafil, posaconazole, Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis, 25/10/2005, 32, Authorised
22/02/2022 Human medicines European public assessment report (EPAR): Gencebok, Caffeine citrate, Apnea, 19/08/2020, 6, Authorised
22/02/2022 Direct healthcare professional communication (DHPC): Xagrid (anagrelide hydrochloride): Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation, Active substance: Anagrelide, DHPC type: Safety signal, Last updated: 22/02/2022
22/02/2022 Orphan designation: 2-(2-{[2-(1h-benzimidazol-2-yl)ethyl]amino}ethyl)-n-[(3-fluoropyridin-2-yl)methyl]-1,3-oxazole-4-carboxamide trihydrochloride for the: Treatment of sickle cell disease, 19/02/2021, Positive
22/02/2022 Orphan designation: (1R,3S,5R)-2-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromo-3-methylpyridin-2-yl)-5-methyl-2-azabicyclo[3.1.0]hexane-3-carboxamide for the: Treatment of paroxysmal nocturnal haemoglobinuria, 19/02/2021, Positive
22/02/2022 Human medicines European public assessment report (EPAR): Oprymea, pramipexole dihydrochloride monohydrate, Parkinson Disease, 12/09/2008, Generic, 21, Authorised
22/02/2022 Orphan designation: Anti-SIGLEC8 IgG1 humanised monoclonal antibody for the: Treatment of eosinophilic gastroenteritis, 19/02/2021, Positive
22/02/2022 Orphan designation: 18-(p-[131I]-iodophenyl)octadecyl phosphocholine for the: Treatment of lymphoplasmacytic lymphoma, 19/02/2021, Positive
22/02/2022 Orphan designation: 2'-O-methyl phosphorothioate RNA oligonucleotide, 5'-m5CUGm5CUGm5CUGm5CUGm5CUGm5CUGm5CUG-3' for the: Treatment of spinocerebellar ataxia, 19/02/2021, Positive
22/02/2022 News and press releases: European medicines regulatory network adopts EU common standard for electronic product information
22/02/2022 Product-information requirements
22/02/2022 Report: Report on public consultation on EU Common Standard for electronic product information (ePI) - Summary of comments received and next steps
22/02/2022 Overview of comments: EU Common Standard for electronic product information (ePI) - categorised comments received following public consultation
22/02/2022 Human medicines European public assessment report (EPAR): Rekambys, rilpivirine, HIV Infections, 17/12/2020, Additional monitoring, 5, Authorised
22/02/2022 Human medicines European public assessment report (EPAR): Epidyolex, Cannabidiol, Lennox Gastaut Syndrome; Epilepsies, Myoclonic, 19/09/2019, Orphan, 10, Authorised
22/02/2022 Veterinary medicines European public assessment report (EPAR): Letifend, Recombinant protein Q from Leishmania infantum MON-1, 20/04/2016, 11, Authorised
21/02/2022 World Health Organization (WHO)
21/02/2022 Paediatric Committee (PDCO): 20-23 July 2021 , Virtual meeting, from 20/07/2021 to 23/07/2021
21/02/2022 Minutes: Minutes - PDCO minutes of the 20-23 July 2021 meeting
21/02/2022 Work programme: PDCO work plan 2022
21/02/2022 Union Pharmacovigilance Database: follow up webinar on collection and recording of suspected adverse events for veterinary medicinal products , Online, 10:00-13:00 Amsterdam time (CET), from 18/01/2022 to 18/01/2022
21/02/2022 News and press releases: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 February 2022
21/02/2022 Summary of opinion: RenuTend, tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells, 16/02/2022, Positive
21/02/2022 Summary of opinion: Chanaxin, tulathromycin, 16/02/2022, Positive
21/02/2022 Agenda: Agenda - CHMP agenda of the 21-24 February 2022 meeting
21/02/2022 Human medicines European public assessment report (EPAR): Suboxone, buprenorphine, naloxone, Opioid-Related Disorders, 26/09/2006, 20, Authorised
21/02/2022 Orphan designation: Octreotide acetate for the: Treatment of acromegaly, 05/08/2013, Positive
21/02/2022 Periodic safety update single assessment: Acenocoumarol : List of nationally authorised medicinal products - PSUSA/00000027/202107
21/02/2022 Periodic safety update single assessment: Urapidil : List of nationally authorised medicinal products - PSUSA/00003078/202107
21/02/2022 Human medicines European public assessment report (EPAR): Akynzeo, netupitant, palonosetron hydrochloride, Vomiting; Neoplasms; Nausea; Cancer, 27/05/2015, 13, Authorised
21/02/2022 Veterinary medicines European public assessment report (EPAR): Vectra 3D, dinotefuran, pyriproxyfen, permethrin, 04/12/2013, 7, Authorised
21/02/2022 Agenda: Agenda - COMP agenda of the 15-17 February 2022 meeting
21/02/2022 Veterinary medicines European public assessment report (EPAR): Librela, bedinvetmab, 10/11/2020, 1, Authorised
21/02/2022 Human medicines European public assessment report (EPAR): Orencia, Abatacept, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid, 21/05/2007, 37, Authorised
18/02/2022 Human medicines European public assessment report (EPAR): Evotaz, cobicistat, atazanavir, HIV Infections, 13/07/2015, 12, Authorised
18/02/2022 Human medicines European public assessment report (EPAR): Reyataz, atazanavir (as sulfate), HIV Infections, 01/03/2004, 52, Authorised
18/02/2022 Orphan designation: Sirolimus for the: Treatment of sporadic lymphangioleiomyomatosis, 14/07/2016, Positive
18/02/2022 Human medicines European public assessment report (EPAR): Leganto, rotigotine, Restless Legs Syndrome; Parkinson Disease, 16/06/2011, 19, Withdrawn
18/02/2022 Financial management and budgetary reporting
18/02/2022 Other: Union Product Database - FAQs - questions and answers for industry users
18/02/2022 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 12-15 October 2021
18/02/2022 Regulatory and procedural guideline: Member states contact points for translations review
18/02/2022 Other: Principal documents taken into account for the preparation of procedures for GCP inspections requested by the CHMP
18/02/2022 Human medicines European public assessment report (EPAR): Temozolomide Teva, temozolomide, Glioma; Glioblastoma, 28/01/2010, Generic, 21, Authorised
18/02/2022 Orphan designation: Pracinostat for the: Treatment of acute myeloid leukaemia, 16/10/2017, Withdrawn
18/02/2022 Orphan designation: Pevonedistat for the: Treatment of acute myeloid leukaemia, 25/07/2019, Withdrawn
18/02/2022 Orphan designation: Pevonedistat for the: Treatment of myelodysplastic syndromes, 14/12/2018, Withdrawn
18/02/2022 Human medicines European public assessment report (EPAR): Byannli (previously Paliperidone Janssen-Cilag International), paliperidone palmitate, Schizophrenia, 18/06/2020, 2, Authorised
17/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Pegcetacoplan, PM: decision on the application for modification of an agreed PIP, P/0210/2021
17/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): dostarlimab, PM: decision on the application for modification of an agreed PIP, P/0211/2021
17/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Cipaglucosidase alfa, PM: decision on the application for modification of an agreed PIP, P/0204/2021
17/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Zejula, Niraparib (tosilate monohydrate), PM: decision on the application for modification of an agreed PIP, P/0184/2021
17/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Zynrelef, bupivacaine,meloxicam (HTX-011), PM: decision on the application for modification of an agreed PIP, P/0182/2021
17/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Sarclisa, Isatuximab, PM: decision on the application for modification of an agreed PIP, P/0185/2021
17/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Avacopan, PM: decision on the application for modification of an agreed PIP, P/0181/2021
17/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Byfavo, Remimazolam (as besilate), PM: decision on the application for modification of an agreed PIP, P/0180/2021
17/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Birch pollen extract (Betula verrucosa), PM: decision on the application for modification of an agreed PIP, P/0207/2021
17/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Pegunigalsidase alfa, PM: decision on the application for modification of an agreed PIP, P/0193/2021
17/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Symtuza, darunavir,cobicistat,emtricitabine,tenofovir alafenamide, PM: decision on the application for modification of an agreed PIP, P/0198/2021
17/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Juluca, rilpivirine,dolutegravir, PM: decision on the application for modification of an agreed PIP, P/0209/2021
17/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab, PM: decision on the application for modification of an agreed PIP, P/0196/2021
17/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Rxulti, brexpiprazole, PM: decision on the application for modification of an agreed PIP, P/0191/2021
17/02/2022 Orphan designation: lonapegsomatropin for the: Treatment of growth hormone deficiency, 17/10/2019, Positive
17/02/2022 Report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: December 2021
17/02/2022 Orphan designation: Pridopidine hydrochloride for the: Treatment of amyotrophic lateral sclerosis, 19/07/2021, Positive
16/02/2022 Human medicines European public assessment report (EPAR): Steglatro, ertugliflozin l-pyroglutamic acid, Diabetes Mellitus, Type 2, 21/03/2018, Additional monitoring, 7, Authorised
16/02/2022 Agenda: Agenda - CAT agenda of the 16-17 February 2022 meeting
16/02/2022 Human medicines European public assessment report (EPAR): Segluromet, ertugliflozin l-pyroglutamic acid, metformin hydrochloride, Diabetes Mellitus, Type 2, 23/03/2018, Additional monitoring, 5, Authorised
16/02/2022 Clinical pharmacology and pharmacokinetics: questions and answers
16/02/2022 Periodic safety update single assessment: Nadroparin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002104/202103
16/02/2022 Periodic safety update single assessment: Nadroparin : List of nationally authorised medicinal products - PSUSA/00002104/202103
16/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Kisplyx, Lenvatinib, PM: decision on the application for modification of an agreed PIP, P/0205/2021
16/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Xgeva, denosumab, PM: decision on the application for modification of an agreed PIP, P/0213/2021
16/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): NexoBrid, Concentrate of proteolytic enzymes in bromelain, PM: decision on the application for modification of an agreed PIP, P/0189/2021
16/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Translarna, Ataluren, PM: decision on the application for modification of an agreed PIP, P/0195/2021
16/02/2022 Human medicines European public assessment report (EPAR): Empliciti, Elotuzumab, Multiple Myeloma, 11/05/2016, Accelerated assessment, Additional monitoring, 9, Authorised
16/02/2022 Human medicines European public assessment report (EPAR): Karvea, irbesartan, Hypertension, 26/08/1997, 43, Authorised
16/02/2022 Human medicines European public assessment report (EPAR): Karvezide, irbesartan, hydrochlorothiazide, Hypertension, 16/10/1998, 43, Authorised
16/02/2022 Human medicines European public assessment report (EPAR): Aprovel, irbesartan, Hypertension, 26/08/1997, 45, Authorised
16/02/2022 Human medicines European public assessment report (EPAR): CoAprovel, irbesartan, hydrochlorothiazide, Hypertension, 14/10/1998, 45, Authorised
16/02/2022 Veterinary medicines European public assessment report (EPAR): Tessie, Tasipimidine sulfate, 16/08/2021, Authorised
16/02/2022 Veterinary medicines European public assessment report (EPAR): NexGard Combo, eprinomectin, esafoxolaner, praziquantel, 06/01/2021, 1, Authorised
15/02/2022 Periodic safety update single assessment: Tamsulosin : List of nationally authorised medicinal products : PSUSA/00002847/202107
15/02/2022 Periodic safety update single assessment: Dexchlorpheniramine : List of nationally authorised medicinal products - PSUSA/00000989/202106
15/02/2022 Other: Timetable: Type II variation and worksharing application alternative monthly assessment
15/02/2022 Newsletter: CTIS newsflash - 11 February 2022
15/02/2022 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Matricariae flos
15/02/2022 Herbal medicinal product: Helichrysi flos, Helichrysi flos, F: Assessment finalised
15/02/2022 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Helichrysi flos
15/02/2022 Human medicines European public assessment report (EPAR): Raylumis, Tanezumab, Osteoarthritis; Pain, 15/11/2021, Refused
15/02/2022 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Ginkgo folium
15/02/2022 Medicine QA: Questions and answers on the refusal of the marketing authorisation for Raylumis (tanezumab)
15/02/2022 Herbal medicinal product: Eschscholziae herba, Eschscholziae herba, F: Assessment finalised
15/02/2022 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Eschscholziae herba
15/02/2022 Periodic safety update single assessment: Quinapril : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002591/202104
15/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): sumatriptan,naproxen (sodium), W: decision granting a waiver in all age groups for all conditions or indications, P/0208/2021
15/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Pembrolizumab,quavonlimab, W: decision granting a waiver in all age groups for all conditions or indications, P/0192/2021
15/02/2022 News and press releases: Veterinary medicines: highlights of 2021
15/02/2022 Periodic safety update single assessment: Allergen for therapy: betula verrucosa (sublingual tablet) : List of nationally authorised medicinal products - PSUSA/00010815/202107
15/02/2022 News and press releases: Human medicines: highlights of 2021
15/02/2022 Report: Human medicines highlights 2021
15/02/2022 Report: Veterinary medicines highlights 2021
15/02/2022 Periodic safety update single assessment: Bovine lung phospholipid : List of nationally authorised medicinal products - PSUSA/00010791/202106
15/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): (S)-N-(1-amino-4-(dimethylamino)-1-oxobutan-2-yl)-5-(2,4-difluorophenoxy)-1-isobutyl-1H-indazole- 6-carboxamide, W: decision granting a waiver in all age groups for all conditions or indications, P/0183/2021
15/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): anti-CD40L humanized monoclonal antibody (SAR441344), W: decision granting a waiver in all age groups for all conditions or indications, P/0200/2021
15/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): (S)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropane-2-yl)-1H-pyrazole-4-carboxamide, W: decision granting a waiver in all age groups for all conditions or indications, P/0197/2021
15/02/2022 EudraVigilance: electronic reporting
15/02/2022 Agenda: Agenda - CVMP agenda of the 15-17 February 2022 meeting
15/02/2022 Newsletter: Medicinal products for human use: monthly figures - December 2021
15/02/2022 Newsletter: Big Data highlights - Issue 1
15/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Argon,oxygen, W: decision granting a waiver in all age groups for all conditions or indications, P/0187/2021
15/02/2022 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Epilobii herba
15/02/2022 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Crataegi folium cum flore - Revision 1
15/02/2022 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Capsici fructus
15/02/2022 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Agrimoniae herba - Revision 1
14/02/2022 Periodic safety update single assessment: Desogestrel : List of nationally authorised medicinal products - PSUSA/00000966/202107
14/02/2022 Periodic safety update single assessment: Fosinopril, fosinopril / hydrochlorothiazide : List of nationally authorised medicinal products - PSUSA/00010463/202107
14/02/2022 Veterinary medicines European public assessment report (EPAR): Mhyosphere PCV ID, Mycoplasma hyopneumoniae, strain 7304 (Nexhyon), expressing the capsid protein of porcine circovirus type 2a, inactivated, 18/08/2020, 1, Authorised
14/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Respiratory syncytial virus stabilised prefusion f subunit vaccine (RSVpreF), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0202/2021
14/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): edaravone, W: decision granting a waiver in all age groups for all conditions or indications, P/0203/2021
14/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Deferoxamine (mesylate),histidine,tryptophan,aspartic acid,n-acetyl-histidine (monohydrate),glycine,alpha-ketoglutaric acid,arginine,potassium chloride,magnesium chloride (hexahydrate),calcium chloride (dihydrate),sodium chloride,alanine,3,4-dimethoxy-N-methylbenzohydroxamic acid (Custodiol-N), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0190/2021
14/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Human anti-interleukin-15 (IL-15) monoclonal antibody, W: decision granting a waiver in all age groups for all conditions or indications, P/0199/2021
14/02/2022 Orphan designation: Rilzabrutinib for the: Treatment of immune thrombocytopenia, 04/06/2020, Positive
14/02/2022 Human medicines European public assessment report (EPAR): Bridion, sugammadex, Neuromuscular Blockade, 25/07/2008, 20, Authorised
14/02/2022 Direct healthcare professional communication (DHPC): Mavenclad (cladribine) – risk of serious liver injury and new recommendations about liver function monitoring, Active substance: Cladribine, DHPC type: Adverse event, Last updated: 14/02/2022
14/02/2022 Human medicines European public assessment report (EPAR): Tukysa, Tucatinib, Breast Neoplasms; Neoplasm Metastasis, 11/02/2021, Additional monitoring, 2, Authorised
11/02/2022 Human medicines European public assessment report (EPAR): Zyprexa Velotab, olanzapine, Schizophrenia; Bipolar Disorder, 03/02/2000, 31, Authorised
11/02/2022 Human medicines European public assessment report (EPAR): Zypadhera, olanzapine pamoate, Schizophrenia, 19/11/2008, 21, Authorised
11/02/2022 Human medicines European public assessment report (EPAR): Buccolam, midazolam, Epilepsy, 04/09/2011, 15, Authorised
11/02/2022 Human medicines European public assessment report (EPAR): Alkindi, hydrocortisone, Adrenal Insufficiency, 09/02/2018, 7, Authorised
11/02/2022 Human medicines European public assessment report (EPAR): Baraclude, Entecavir, Hepatitis B, Chronic, 26/06/2006, 27, Authorised
11/02/2022 Periodic safety update single assessment: Daunorubicin : List of nationally authorised medicinal products - PSUSA/00000936/202106
11/02/2022 Veterinary medicines European public assessment report (EPAR): Poulvac E. coli, Live aroA gene deleted Escherichia coli, type 078, strain EC34195, 15/06/2012, 10, Authorised
11/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Pelgraz, pegfilgrastim, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0206/2021
11/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): rAAV8 viral vector encoding the human UGT1A1 transgene (rAAV8-hUGT1A1), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0194/2021
11/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Reparixin, RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s), P/0188/2021
11/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Entyvio, vedolizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0186/2021
11/02/2022 Veterinary medicines European public assessment report (EPAR): Tulinovet, tulathromycin, 16/09/2020, Generic, 2, Authorised
11/02/2022 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 - 10 February 2022
11/02/2022 News and press releases: PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
11/02/2022 News and press releases: EMA starts safety review of Janus kinase inhibitors for inflammatory disorders
11/02/2022 Referral: Hydroxyethyl starch (HES) containing medicinal products , hydroxyethyl starch, Article 107i procedures, European Commission final decision, 26/10/2017, 17/07/2018, 11/02/2022
11/02/2022 EMA regular press briefing on COVID-19 , Online, 14:00 - 14:30 Amsterdam time (CET), from 17/02/2022 to 17/02/2022
11/02/2022 Notifying EMA of changes to contact persons (veterinary medicines)
11/02/2022 Other: List of eligible industry stakeholder organisations
11/02/2022 Changing the (invented) name of a veterinary medicine
11/02/2022 Periodic safety update single assessment: Cefepime : List of nationally authorised medicinal products - PSUSA/00000593/202106
11/02/2022 Periodic safety update single assessment: Lidocaine hydrochloride/phenylephrine hydrochloride/tropicamide : List of nationally authorised medicinal products : PSUSA/00010390/202107
11/02/2022 Periodic safety update single assessment: Solifenacin-tamsulosin : List of nationally authorised medicinal products - PSUSA/00010285/202107
11/02/2022 Periodic safety update single assessment: Ibuprofen / pseudoephedrine : List of nationally authorised medicinal products - PSUSA/00001711/202107
10/02/2022 Report: Annual Report of the Good Clinical Practice Inspectors Working Group 2019
10/02/2022 Clinical Trials Information System (CTIS) demonstration for stakeholders , Online, 09:00-17:00 Amsterdam time (CET), from 20/01/2022 to 20/01/2022
10/02/2022 Human medicines European public assessment report (EPAR): Translarna, Ataluren, Muscular Dystrophy, Duchenne, 31/07/2014, Orphan, Additional monitoring, Conditional approval, 21, Authorised
10/02/2022 Minutes: CHMP PROM minutes for the meeting on 6 December 2021
10/02/2022 Agenda: CHMP PROM agenda for the meeting on 6 December 2021
10/02/2022 Other: Timetable: Annual renewal application of conditional marketing authorisation - ATMP
10/02/2022 Other: Timetable: Initial (full) marketing authorisation application assessment
10/02/2022 Human medicines European public assessment report (EPAR): Efavirenz Teva, efavirenz, HIV Infections, 09/01/2012, Generic, 11, Authorised
10/02/2022 Eligible healthcare professionals' organisations
10/02/2022 Human medicines European public assessment report (EPAR): DaTSCAN, ioflupane (123l), Tomography, Emission-Computed, Single-Photon; Lewy Body Disease; Parkinson Disease; Alzheimer Disease, 27/07/2000, 23, Authorised
10/02/2022 Veterinary medicines European public assessment report (EPAR): Loxicom, meloxicam, 10/02/2009, Generic, 17, Authorised
09/02/2022 Report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 24-26 January 2022
09/02/2022 Veterinary medicines European public assessment report (EPAR): Tulaven, tulathromycin, 24/04/2020, Generic, 3, Authorised
09/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human βA-T87Q-globin gene, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0234/2019
09/02/2022 Human medicines European public assessment report (EPAR): Zercepac, trastuzumab, Breast Neoplasms; Stomach Neoplasms, 27/07/2020, Additional monitoring, Biosimilar, 7, Authorised
09/02/2022 Data Analysis and Real World Interrogation Network (DARWIN EU)
09/02/2022 News and press releases: Initiation of DARWIN EU® Coordination Centre advances integration of real-world evidence into assessment of medicines in the EU
09/02/2022 Human medicines European public assessment report (EPAR): Atosiban SUN, atosiban (as acetate), Premature Birth, 31/07/2013, Generic, 9, Authorised
09/02/2022 Orphan designation: 68Ga-2,2'-(7-(4-((S)-1-((4S,7S,10S,13R,16S,19R)-4-((R)-1-amino-3-(4-hydroxyphenyl)-1-oxopropan-2-ylcarbamoyl)-10-(4-aminobutyl)-16-(4-((S)-2,6-dioxohexahydropyrimidine-4-carboxamido)benzyl)-7-((R)-1-hydroxyethyl)-6,9,12,15,18-pentaoxo-13-(4-ureidobenzyl)-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-19-ylamino)-3-(4-chlorophenyl)-1-oxopropan-2-ylamino)-1-carboxy-4-oxobutyl)-1,4,7-triazonane-1,4-diyl)diacetic acid (satoreotide trixozetan)  for the: Diagnosis of gastro-entero-pancreatic neuroendocrine tumours, 19/02/2014, Positive
09/02/2022 Orphan designation: Lutetium-177(3+), S2,S7-cyclo[N-{4,7,10-tricarboxymethyl-1,4,7,10-tetraaza-cyclododecan-1-yl-acetyl}-4-chloro-L-phenylalanyl-D-cysteinyl-4-[(4S)-2,6-dioxo-1,3-diazinane-4-carboxamido]-L-phenylalanyl-4-(carbamoylamino)-D-phenylalanyl-L-lysyl-L-threonyl-L-cysteinyl-D-tyrosinamide]- for the: Treatment of gastro-entero-pancreatic neuroendocrine tumours, 20/09/2016, Positive
09/02/2022 Human medicines European public assessment report (EPAR): Ifirmacombi, irbesartan, hydrochlorothiazide, Hypertension, 04/03/2011, Generic, 14, Authorised
09/02/2022 Human medicines European public assessment report (EPAR): Rasilez, aliskiren, Hypertension, 22/08/2007, 25, Authorised
09/02/2022 Human medicines European public assessment report (EPAR): Javlor, vinflunine, Carcinoma, Transitional Cell; Urologic Neoplasms, 21/09/2009, 9, Authorised
09/02/2022 Human medicines European public assessment report (EPAR): Emselex, darifenacin hydrobromide, Urinary Incontinence, Urge; Urinary Bladder, Overactive, 22/10/2004, 25, Authorised
09/02/2022 Human medicines European public assessment report (EPAR): Busilvex, busulfan, Hematopoietic Stem Cell Transplantation, 09/07/2003, 19, Authorised
09/02/2022 Human medicines European public assessment report (EPAR): Invanz, ertapenem sodium, Community-Acquired Infections; Streptococcal Infections; Staphylococcal Infections; Gram-Negative Bacterial Infections; Surgical Wound Infection; Pneumonia, Bacterial, 18/04/2002, 25, Authorised
08/02/2022 Committee for Advanced Therapies (CAT) meeting with interested parties , Online, from 26/10/2021 to 26/10/2021
08/02/2022 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 7-10 September 2021
08/02/2022 News and press releases: EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty in adolescents
08/02/2022 Human medicines European public assessment report (EPAR): Staquis, Crisaborole, Dermatitis, Atopic, 27/03/2020, Additional monitoring, 6, Withdrawn
08/02/2022 Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0146/2018
08/02/2022 Periodic safety update single assessment: Hydrochlorothiazide / quinapril : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002592/202104
08/02/2022 Periodic safety update single assessment: Hydrochlorothiazide / quinapril : List of nationally authorised medicinal products - PSUSA/00002592/202104
08/02/2022 Periodic safety update single assessment: Quinapril : List of nationally authorised medicinal products - PSUSA/00002591/202104
08/02/2022 Human medicines European public assessment report (EPAR): Deferasirox Accord, deferasirox, Iron Overload; beta-Thalassemia, 09/01/2020, Generic, 3, Authorised
08/02/2022 Network Portfolio
08/02/2022 Other: Network Portfolio Advisory Group (NPAG) - Membership and role
08/02/2022 Other: Network Portfolio Advisory Group (NPAG) - Terms of reference
08/02/2022 Other: EMA Agile governance model