DateContentStatus
07/06/2024 PIP: EMEA-003184-PIP01-22 - paediatric investigation planNew
07/06/2024 PIP: EMEA-003080-PIP03-22 - paediatric investigation planNew
07/06/2024 PIP: EMEA-002612-PIP02-22 - paediatric investigation planNew
07/06/2024 PIP: EMEA-003079-PIP01-22 - paediatric investigation planNew
07/06/2024 Orphan: EU/3/13/1200 - orphan designation for treatment of papillary thyroid cancerUpdated
07/06/2024 Orphan: EU/3/13/1199 - orphan designation for treatment of follicular thyroid cancerUpdated
07/06/2024 Medicine: NexavarUpdated
07/06/2024 Medicine: SylvantUpdated
07/06/2024 Orphan: EU/3/07/508 - orphan designation for treatment of Castleman's diseaseUpdated
07/06/2024 Medicine: Lamivudine TevaUpdated
07/06/2024 Medicine: Emtricitabine/Tenofovir disoproxil ZentivaUpdated
07/06/2024 PIP: EMEA-000032-PIP02-22 - paediatric investigation planNew
07/06/2024 Medicine: Irbesartan/Hydrochlorothiazide TevaUpdated
07/06/2024 PIP: EMEA-003370-PIP01-22 - paediatric investigation planNew
07/06/2024 PIP: EMEA-003364-PIP02-22 - paediatric investigation planNew
07/06/2024 PIP: EMEA-003339-PIP02-23 - paediatric investigation planNew
07/06/2024 PIP: EMEA-003302-PIP01-22 - paediatric investigation planNew
07/06/2024 PIP: EMEA-003279-PIP01-22 - paediatric investigation planNew
07/06/2024 PIP: EMEA-003251-PIP01-22 - paediatric investigation planNew
07/06/2024 PIP: EMEA-003208-PIP02-22 - paediatric investigation planNew
07/06/2024 PIP: EMEA-001231-PIP02-13-M10 - paediatric investigation planUpdated
07/06/2024 Medicine: ParsabivUpdated
06/06/2024 Event: Follow up EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcomaUpdated
06/06/2024 PIP: EMEA-001214-PIP09-21-M01 - paediatric investigation planUpdated
06/06/2024 PIP: EMEA-001194-PIP01-11-M06 - paediatric investigation planUpdated
06/06/2024 Medicine: SkyclarysUpdated
06/06/2024 Medicine: LitfuloUpdated
06/06/2024 Medicine: RizmoicUpdated
06/06/2024 Medicine: HizentraUpdated
06/06/2024 Medicine: Sitagliptin / Metformin hydrochloride SunUpdated
06/06/2024 Medicine: ByfavoUpdated
06/06/2024 Medicine: TysabriUpdated
06/06/2024 Medicine: MimparaUpdated
06/06/2024 Medicine: JubbontiUpdated
06/06/2024 Document: List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)Updated
06/06/2024 Medicine: QdengaUpdated
06/06/2024 PSUSA: PSUSA/00003043/202308 - periodic safety update report single assessmentNew
06/06/2024 Medicine: EnbrelUpdated
06/06/2024 Event: Product Management Service (PMS) Product UI training (access & navigation)Updated
06/06/2024 Medicine: TrodelvyUpdated
06/06/2024 Medicine: Myocet liposomal (previously Myocet)Updated
06/06/2024 Medicine: GiaprezaUpdated
05/06/2024 PSUSA: PSUSA/00003121/202308 - periodic safety update report single assessmentNew
05/06/2024 Medicine: ReyatazUpdated
05/06/2024 Medicine: ErbituxUpdated
05/06/2024 Medicine: BeyfortusUpdated
05/06/2024 Medicine: PecFentUpdated
05/06/2024 Medicine: AlprolixUpdated
05/06/2024 Medicine: CamceviUpdated
05/06/2024 Medicine: Abilify MaintenaUpdated
05/06/2024 Document: List of medicines currently in PRIME schemeUpdated
05/06/2024 Document: Application form for European Medicines Agency certificates of medicinal productsUpdated
04/06/2024 Medicine: XromiUpdated
04/06/2024 Medicine: OxbrytaUpdated
04/06/2024 Medicine: OnpattroUpdated
04/06/2024 Medicine: SuliquaUpdated
04/06/2024 Medicine: XultophyUpdated
04/06/2024 PSUSA: PSUSA/00002114/202308 - periodic safety update report single assessmentNew
03/06/2024 Medicine: CredelioUpdated
03/06/2024 News: EU recommendations for 2024/2025 seasonal flu vaccine compositionUpdated
03/06/2024 Medicine: ComirnatyUpdated
03/06/2024 Document: IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicantsUpdated
03/06/2024 Medicine: XareltoUpdated
03/06/2024 Document: Template - Request for compliance check on an agreed paediatric investigation plan (PIP)Updated
03/06/2024 Medicine: DacogenUpdated
03/06/2024 Document: Template for scientific documentUpdated
03/06/2024 Document: Paediatric investigation plan (PIP) - Key elements guidanceUpdated
03/06/2024 Medicine: SomaKit TOCUpdated
03/06/2024 Medicine: Sunitinib AccordUpdated
03/06/2024 Medicine: SuboxoneUpdated
03/06/2024 Medicine: CircovacUpdated
03/06/2024 Medicine: FilspariUpdated
03/06/2024 Medicine: AwiqliUpdated
03/06/2024 Medicine: XtandiUpdated
03/06/2024 Page: Recommendations on medication errorsUpdated
03/06/2024 Medicine: BravectoUpdated
03/06/2024 Medicine: ImfinziUpdated
03/06/2024 Medicine: ImjudoUpdated
03/06/2024 Medicine: BimervaxUpdated
03/06/2024 Medicine: CufenceUpdated
03/06/2024 Medicine: ZilbrysqUpdated
03/06/2024 Medicine: Innovax-ND-H5Updated
03/06/2024 Medicine: RozlytrekUpdated
03/06/2024 Medicine: OmlycloUpdated
03/06/2024 Document: Shortage of human normal immunoglobulinsNew