DateContentStatus
29/05/2024 Medicine: DynastatUpdated
29/05/2024 Page: National registers of authorised medicinesUpdated
29/05/2024 Medicine: Zolsketil pegylated liposomalUpdated
29/05/2024 Medicine: OmlycloUpdated
28/05/2024 Medicine: Zoonotic Influenza Vaccine SeqirusUpdated
28/05/2024 PSUSA: PSUSA/00001642/202309 - periodic safety update report single assessmentNew
28/05/2024 Medicine: FilspariUpdated
28/05/2024 PIP: EMEA-002233-PIP01-17-M02 - paediatric investigation planUpdated
28/05/2024 Medicine: TruvadaUpdated
28/05/2024 Medicine: XromiUpdated
28/05/2024 Medicine: ReagilaUpdated
28/05/2024 Document: Sodium salicylate (poultry other than turkey): European Public MRL Assessment Report (EPMAR) - CVMPNew
28/05/2024 Medicine: SarclisaUpdated
28/05/2024 Medicine: Filgrastim HexalUpdated
28/05/2024 Document: Agenda - PDCO agenda of the 28-31 May 2024 meetingNew
28/05/2024 Event: DARWIN EU Advisory Board meeting - 11 December 2023Updated
28/05/2024 Medicine: ZarzioUpdated
28/05/2024 Medicine: RetsevmoUpdated
28/05/2024 Medicine: BetmigaUpdated
28/05/2024 Medicine: NuceivaUpdated
27/05/2024 Medicine: LoargysUpdated
27/05/2024 Document: Agenda of the CHMP meeting 27-30 May 2024New
27/05/2024 Medicine: Vectormune FP ILTUpdated
27/05/2024 Medicine: RonapreveUpdated
27/05/2024 Medicine: RotarixUpdated
24/05/2024 Medicine: SotyktuUpdated
24/05/2024 Medicine: Tenofovir disoproxil ZentivaUpdated
24/05/2024 Medicine: VyvgartUpdated
24/05/2024 Medicine: RinvoqUpdated
24/05/2024 Medicine: Vyxeos liposomal (previously known as Vyxeos)Updated
24/05/2024 Medicine: SaphneloUpdated
24/05/2024 Medicine: NexviadymeUpdated
24/05/2024 Medicine: BenlystaUpdated
24/05/2024 Event: Committee for Herbal Medicinal Products (HMPC): 27-29 May 2024Updated
24/05/2024 Medicine: OrserduUpdated
24/05/2024 Medicine: SkyriziUpdated
24/05/2024 Medicine: TachoSilUpdated
24/05/2024 Medicine: LocametzUpdated
24/05/2024 Medicine: SprycelUpdated
24/05/2024 Medicine: Atazanavir Viatris (previously Atazanavir Mylan)Updated
24/05/2024 Post-authorisation: Bluevac BTV (previously known as Bluevac BTV8) - opinion on variation to marketing authorisationNew
24/05/2024 Medicine: Nobilis Multriva RT+IBm+ND+Gm+REOmNew
24/05/2024 Medicine: Nobilis Multriva RT+IBm+ND+EDSNew
24/05/2024 News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 May 2024New
24/05/2024 Medicine: Darunavir Viatris (previously Darunavir Mylan)Updated
24/05/2024 Page: Industry annual bilateral meetingsUpdated
24/05/2024 Event: Seventh European Medicines Agency - Medicines for Europe annual bilateral meetingNew
23/05/2024 Event: European Shortages Monitoring Platform Essentials and Industry Reporting RequirementsNew
23/05/2024 Medicine: BinocritUpdated
23/05/2024 Medicine: Epoetin Alfa HexalUpdated
23/05/2024 Medicine: AbseamedUpdated
23/05/2024 Medicine: SpravatoUpdated
23/05/2024 Medicine: TizveniUpdated
23/05/2024 Event: Environmental Risk Assessment (ERA) Assessors TrainingNew
23/05/2024 Medicine: StrangvacUpdated
23/05/2024 Medicine: LumykrasUpdated
23/05/2024 Medicine: ArexvyUpdated
23/05/2024 Herbal: Rhodiolae roseae rhizoma et radix - herbal medicinal productUpdated
23/05/2024 Medicine: LysaKareUpdated
23/05/2024 Medicine: Zonisamide MylanUpdated
23/05/2024 Medicine: Enerzair BreezhalerUpdated
23/05/2024 Medicine: LoxitabUpdated
23/05/2024 Medicine: EluracatUpdated
23/05/2024 Medicine: OxmaxUpdated
23/05/2024 Medicine: Atectura BreezhalerUpdated
23/05/2024 Medicine: CerezymeUpdated
22/05/2024 Medicine: IbranceUpdated
22/05/2024 Medicine: NubeqaUpdated
22/05/2024 Medicine: ImvanexUpdated
22/05/2024 Medicine: FlixabiUpdated
22/05/2024 Medicine: Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)Updated
22/05/2024 Medicine: AmgevitaUpdated
22/05/2024 Medicine: KrazatiUpdated
22/05/2024 Medicine: TevimbraUpdated
22/05/2024 Medicine: SpexotrasUpdated
22/05/2024 Medicine: RoclandaUpdated
22/05/2024 Medicine: StayveerUpdated
22/05/2024 Medicine: Fulvestrant MylanUpdated
22/05/2024 Medicine: MekinistUpdated
22/05/2024 Medicine: ViagraUpdated
21/05/2024 PIP: EMEA-003273-PIP02-22 - paediatric investigation planNew
21/05/2024 PSUSA: PSUSA/00000958/202309 - periodic safety update report single assessmentNew
21/05/2024 PIP: EMEA-003090-PIP02-22 - paediatric investigation planNew
21/05/2024 PIP: EMEA-003355-PIP01-22 - paediatric investigation planNew
21/05/2024 Medicine: TafinlarUpdated
21/05/2024 Medicine: FinleeUpdated
21/05/2024 Medicine: TecentriqUpdated
21/05/2024 Medicine: QuviviqUpdated
21/05/2024 Medicine: ErleadaUpdated
21/05/2024 Medicine: TepmetkoUpdated
21/05/2024 Event: Product Management Service (PMS) Product UI and API training (access & navigation)Updated
21/05/2024 Medicine: Palonosetron AccordUpdated
21/05/2024 News: EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine TranslarnaUpdated
21/05/2024 Document: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)Updated
21/05/2024 Medicine: MysildecardUpdated
21/05/2024 Document: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changesUpdated
21/05/2024 Medicine: Apremilast AccordUpdated
21/05/2024 Medicine: CresembaUpdated
21/05/2024 Medicine: Temozolomide SunUpdated
21/05/2024 Document: Agenda of the CVMP meeting 21-23 May 2024New
21/05/2024 Document: Agenda of the COMP meeting 21-23 May 2024New
21/05/2024 Medicine: EvenityUpdated
21/05/2024 Medicine: RekambysUpdated
17/05/2024 PSUSA: PSUSA/00010768/202310 - periodic safety update report single assessmentNew
17/05/2024 Medicine: TrepulmixUpdated
17/05/2024 Medicine: AjovyUpdated
17/05/2024 Medicine: VoydeyaUpdated
17/05/2024 Medicine: Onivyde pegylated liposomal (previously known as Onivyde)Updated
17/05/2024 Page: Outcomes of imposed non-interventional post-authorisation safety studiesUpdated
17/05/2024 Medicine: Miglustat Gen.OrphUpdated
17/05/2024 News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024New
17/05/2024 Medicine: TracleerUpdated
17/05/2024 Medicine: ZepatierUpdated
16/05/2024 PSUSA: PSUSA/00002569/202309 - periodic safety update report single assessmentNew
16/05/2024 PSUSA: PSUSA/00000034/202309 - periodic safety update report single assessmentNew
16/05/2024 PSUSA: PSUSA/00010806/202310 - periodic safety update report single assessmentNew
16/05/2024 Document: Sodium tetradecyl sulphate: List of nationally authorised medicinal products - PSUSA/00002767/202304 New
16/05/2024 Medicine: NplateUpdated
16/05/2024 Medicine: KalydecoUpdated
16/05/2024 Medicine: Temozolomide TevaUpdated
16/05/2024 Document: PDCO minutes of the 19-22 March 2024 meetingNew
16/05/2024 Medicine: ColobreatheUpdated
16/05/2024 Medicine: Fingolimod AccordUpdated
16/05/2024 Event: Information and Q&A session on updated CAPs in web-based eAFUpdated
16/05/2024 Medicine: Pregabalin SandozUpdated
16/05/2024 Medicine: Pregabalin MylanUpdated
16/05/2024 Medicine: Ibuprofen Gen.OrphUpdated
15/05/2024 Medicine: BrukinsaUpdated
15/05/2024 Document: Policy 78: EMA environmental policyUpdated
15/05/2024 Medicine: TasignaUpdated
15/05/2024 Medicine: RyzneutaUpdated
15/05/2024 Medicine: ImcivreeUpdated
15/05/2024 Medicine: NeuraceqUpdated
15/05/2024 Medicine: LyricaUpdated
15/05/2024 Medicine: KaftrioUpdated
15/05/2024 Medicine: UptraviUpdated
14/05/2024 Medicine: Thalidomide LipomedUpdated
14/05/2024 Medicine: MayzentUpdated
14/05/2024 Event: Clinical Trials Information System (CTIS): Walk-in clinic - July 2024Updated
14/05/2024 Medicine: Olanzapine MylanUpdated
14/05/2024 Medicine: VegzelmaUpdated
14/05/2024 Medicine: PoteligeoUpdated
14/05/2024 Medicine: AspaveliUpdated
13/05/2024 Medicine: GONAL-fUpdated
13/05/2024 Medicine: AgamreeUpdated
13/05/2024 Medicine: AxuminUpdated
13/05/2024 Medicine: BexseroUpdated
13/05/2024 Medicine: Ghryvelin (previously Macimorelin Aeterna Zentaris)Updated
13/05/2024 Medicine: ScenesseUpdated
13/05/2024 Medicine: Anagrelide Viatris (previously Anagrelide Mylan)Updated
13/05/2024 Medicine: MyozymeUpdated
13/05/2024 Medicine: FabrazymeUpdated
13/05/2024 Medicine: KaulivUpdated
13/05/2024 Medicine: OnglyzaUpdated
13/05/2024 Medicine: Rasagiline MylanUpdated
13/05/2024 Medicine: Plerixafor AccordUpdated
13/05/2024 Medicine: AtrianceUpdated
13/05/2024 Medicine: SpinrazaUpdated
13/05/2024 Medicine: Granupas (previously Para-aminosalicylic acid Lucane)Updated
13/05/2024 Medicine: VyndaqelUpdated
13/05/2024 Medicine: DupixentUpdated
13/05/2024 Medicine: Telmisartan ActavisUpdated
13/05/2024 Medicine: LuxturnaUpdated
13/05/2024 Medicine: LeqvioUpdated
13/05/2024 Medicine: Heplisav BUpdated
13/05/2024 Medicine: OrkambiUpdated
13/05/2024 Medicine: ReblozylUpdated
13/05/2024 Medicine: AbrysvoUpdated
13/05/2024 Medicine: KeytrudaUpdated
13/05/2024 Medicine: TresibaUpdated
13/05/2024 Medicine: IsentressUpdated
13/05/2024 Medicine: RyzodegUpdated
08/05/2024 Document: Timetable: Post-authorisation safety study (PASS) protocols and final resultsUpdated
08/05/2024 Document: Timetable: Initial (Full) marketing authorisation application - ATMPUpdated
07/05/2024 Medicine: Vaxzevria (previously COVID-19 Vaccine AstraZeneca)Updated
07/05/2024 Herbal: Hippocastani cortex - herbal medicinal productUpdated
07/05/2024 News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024Updated
07/05/2024 Event: Information session on Call for Proposals "EU 4 AMA: leveraging European expertise for medicines regulation in Africa"New
07/05/2024 Document: List of medicines currently in PRIME schemeUpdated
07/05/2024 Medicine: EmblaveoUpdated
06/05/2024 Event: EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcomaUpdated
06/05/2024 PSUSA: PSUSA/00002310/202308 - periodic safety update report single assessmentNew
06/05/2024 Document: Meeting report - Joint EMA/EORTC Workshop on Soft Tissue and Bone Sarcoma WorkshopNew
06/05/2024 Medicine: AdynoviUpdated
06/05/2024 Medicine: AdvateUpdated
06/05/2024 Document: PRAC recommendations on signals adopted at the 8-11 April 2024 PRAC meetingNew
03/05/2024 Medicine: MenQuadfiUpdated
03/05/2024 PIP: EMEA-003157-PIP01-21 - paediatric investigation planUpdated
03/05/2024 Document: Agenda - Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicinesUpdated
03/05/2024 PSUSA: PSUSA/00002589/202307 - periodic safety update report single assessmentNew
03/05/2024 Medicine: BriumviUpdated
03/05/2024 Medicine: SivextroUpdated
03/05/2024 Medicine: TalzennaUpdated
02/05/2024 Document: Template for scientific document (part B-F)Updated
02/05/2024 Herbal: Malvae sylvestris flos - herbal medicinal productUpdated
02/05/2024 Medicine: PelmegUpdated
02/05/2024 Medicine: NoxafilUpdated
02/05/2024 Medicine: Teriflunomide AccordUpdated
02/05/2024 Medicine: ByoovizUpdated
02/05/2024 Medicine: PluvictoUpdated
02/05/2024 Medicine: RotaTeqUpdated
02/05/2024 Medicine: VolibrisUpdated
02/05/2024 Herbal: Malvae folium - herbal medicinal productUpdated
02/05/2024 Medicine: VafseoUpdated
02/05/2024 Medicine: IncellipanUpdated
02/05/2024 Medicine: CelldemicUpdated
02/05/2024 Medicine: ZynyzUpdated
02/05/2024 Document: CAT quarterly highlights and approved ATMPs - February - April 2024New
02/05/2024 Page: Stability testing for applications for variations to a marketing authorisation for veterinary medicinal products - Scientific guidelineUpdated
02/05/2024 Medicine: MirapexinUpdated