DateContentStatus
26/04/2024 Document: QRD Form 2 and checklist for the submission of day +25 files - veterinaryUpdated
26/04/2024 Post-authorisation: Alecensa - opinion on variation to marketing authorisationNew
26/04/2024 Post-authorisation: Reyataz - opinion on variation to marketing authorisationNew
26/04/2024 Post-authorisation: Triumeq - opinion on variation to marketing authorisationNew
26/04/2024 Post-authorisation: Sirturo - opinion on variation to marketing authorisationNew
26/04/2024 Post-authorisation: Opdivo - opinion on variation to marketing authorisationNew
26/04/2024 Post-authorisation: Rozlytrek - opinion on variation to marketing authorisationNew
26/04/2024 Post-authorisation: Rybrevant - opinion on variation to marketing authorisationNew
26/04/2024 Medicine: TruqapNew
26/04/2024 Medicine: WezenlaNew
26/04/2024 Medicine: GeGantNew
26/04/2024 Medicine: Eribulin BaxterNew
26/04/2024 Medicine: AltuvoctNew
26/04/2024 Medicine: ObgemsaNew
26/04/2024 Medicine: JeraygoNew
26/04/2024 News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024New
26/04/2024 Page: SME Regulation and reportsUpdated
26/04/2024 Document: Small and medium-sized enterprise (SME) office annual report 2023New
26/04/2024 Event: Follow up EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcomaNew
26/04/2024 Page: ProcurementUpdated
26/04/2024 Medicine: Spikevax (previously COVID-19 Vaccine Moderna)Updated
26/04/2024 Event: Committee for Medicinal Products for Veterinary Use (CVMP): 12-14 March 2024Updated
26/04/2024 Document: Minutes of the CVMP meeting 12-13 March 2024New
25/04/2024 Medicine: XtandiUpdated
25/04/2024 Event: Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 April 2024Updated
25/04/2024 Medicine: Innovax-ND-H5New
25/04/2024 Document: List of centrally authorised products requiring a notification of a change for update of annexesUpdated
25/04/2024 Page: Non-clinical Working PartyUpdated
25/04/2024 Document: Guide on access to unpublished documentsUpdated
25/04/2024 Event: SPOR Status UpdateUpdated
25/04/2024 Event: EMA workshop on the challenges in drug development, regulation and clinical practice in hemoglobinopathiesNew
25/04/2024 Event: Joint HMA/EMA Big Data Steering Group workshop on RWE methodsUpdated
25/04/2024 Document: Agenda - Joint HMA/EMA Big Data Steering Group Workshop on RWE methodsUpdated
25/04/2024 Medicine: Teriflunomide AccordUpdated
25/04/2024 PSUSA: PSUSA/00002068/202308 - periodic safety update report single assessmentNew
25/04/2024 Medicine: SifrolUpdated
25/04/2024 Medicine: QuviviqUpdated
25/04/2024 Medicine: NepextoUpdated
25/04/2024 Medicine: BimervaxUpdated
24/04/2024 Medicine: TecartusUpdated
24/04/2024 Document: List of eligible industry stakeholder organisationsUpdated
24/04/2024 Medicine: Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)Updated
24/04/2024 Medicine: SpedraUpdated
24/04/2024 Document: Agenda - Fourth EMA-AESGP bilateral meetingNew
24/04/2024 Event: Fifth European Medicines Agency (EMA) and the Association of the European Self-Medication Industry (AESGP) bilateral meetingNew
24/04/2024 Document: Minimum inhibitory concentration (MIC) breakpointsUpdated
24/04/2024 Event: Psychedelics and their therapeutic use - Linkedin Live interview with Steffen Thirstrup, EMA's Chief Medical OfficerNew
24/04/2024 Medicine: FruzaqlaNew
23/04/2024 Page: Training and resources for patients and consumersUpdated
23/04/2024 Medicine: Pramipexole TevaUpdated
23/04/2024 Medicine: SivextroUpdated
23/04/2024 Medicine: OntozryUpdated
23/04/2024 Medicine: EmendUpdated
23/04/2024 Document: Emend (aprepitant) supply shortage Updated
23/04/2024 Medicine: KaftrioUpdated
23/04/2024 Medicine: Sitagliptin / Metformin hydrochloride AccordUpdated
23/04/2024 Medicine: RevatioUpdated
23/04/2024 Medicine: OyavasUpdated
23/04/2024 News: New recommendations to strengthen supply chains of critical medicinesNew
23/04/2024 Page: Executive Steering Group on Shortages and Safety of Medicinal ProductsUpdated
23/04/2024 Document: MSSG recommendations to strengthen supply chains of critical medicinal productsNew
23/04/2024 Medicine: HukyndraUpdated
23/04/2024 Document: Contact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved productsUpdated
23/04/2024 Document: Member states contact points for review of national versions of the content of mobile scanning and other technologiesUpdated
23/04/2024 Document: Contact details of national competent authorities for requests of translation exemptions falling under Art. 63.3 of Directive 2001/83/EC and cases of shortagesUpdated
23/04/2024 Document: Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) GroupUpdated
23/04/2024 Event: Paediatric Committee (PDCO): 23-26 April 2024Updated
23/04/2024 Document: Agenda - PDCO agenda of the 23-26 April 2024 meetingNew
23/04/2024 Document: Agenda of the CHMP meeting 22-25 April 2024Updated
22/04/2024 Medicine: LunsumioUpdated
22/04/2024 PSUSA: PSUSA/00010425/202308 - periodic safety update report single assessmentNew
22/04/2024 PSUSA: PSUSA/00010163/202308 - periodic safety update report single assessmentNew
22/04/2024 Document: List of medicinal products under additional monitoringUpdated
22/04/2024 Document: List of medicinal products under additional monitoringUpdated
22/04/2024 Medicine: LorviquaUpdated
22/04/2024 Medicine: TofidenceNew
22/04/2024 Page: List of medicines under additional monitoringUpdated
22/04/2024 Medicine: JentaduetoUpdated
22/04/2024 Medicine: Posaconazole AHCLUpdated
22/04/2024 Event: Information and Q&A session on updated CAPs in web-based eAFNew
22/04/2024 Medicine: Posaconazole AccordUpdated
22/04/2024 Medicine: LemtradaUpdated
22/04/2024 Page: Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meetingsUpdated
22/04/2024 Event: Clinical Trials Information System (CTIS) Bitesize Talk: How to submit a transitional trial in CTISUpdated
22/04/2024 Medicine: Granupas (previously Para-aminosalicylic acid Lucane)Updated
22/04/2024 Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - April 2024Updated
22/04/2024 Medicine: Nintedanib AccordUpdated
19/04/2024 Medicine: LymphoseekUpdated
19/04/2024 Event: Paediatric Oncology Strategy Forum: 24-25 October 2024New
19/04/2024 Event: Product Management Service (PMS) Info-DayUpdated
19/04/2024 News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 April 2024New
19/04/2024 Medicine: TevimbraUpdated
19/04/2024 Medicine: CyramzaUpdated
19/04/2024 Event: Industry Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRINew
19/04/2024 Event: Network Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRISNew
19/04/2024 Medicine: Respivac TRTNew
19/04/2024 Document: Call for proposals - Grant procedure EMA/GRANT/2024/02/IA “Medicines regulatory systems strengthening in Sub-Saharan Africa”New
19/04/2024 Document: Annex II to the call for proposals - Vendor financial identification formNew
19/04/2024 Document: Annex Va to the call for proposals - Draft grant agreement for an action with one beneficiaryNew
19/04/2024 Document: Annex Vb to the call for proposals - Draft grant agreement for an action with multiple beneficiariesNew
19/04/2024 Event: Product Management Service (PMS) Product UI and API training (access & navigation)New
19/04/2024 Event: EMA multi-stakeholder workshop on psychedelics – Towards an EU regulatory frameworkUpdated
19/04/2024 Event: Committee for Medicinal Products for Human Use (CHMP): 19-22 February 2024Updated
19/04/2024 Medicine: Abiraterone AccordUpdated
19/04/2024 Event: SPOR Status UpdateNew
19/04/2024 Document: Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI)Updated
19/04/2024 Document: Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) - ATMPUpdated
19/04/2024 Document: Timetable: Post-authorisation measure (PAM) Paediatric art. 46 submission - ATMPUpdated
19/04/2024 Document: Timetable: Post-authorisation measure (PAM) assessed by CHMPUpdated
19/04/2024 Document: Timetable: Post-authorisation measure (PAM) Paediatric art. 46 submissionUpdated
19/04/2024 Document: Timetable: Post-authorisation measure (PAM) assessed by PRACUpdated
19/04/2024 Document: Timetable: Post-authorisation measures (PAMs) assessed by PRAC - ATMPUpdated
19/04/2024 Document: Timetable: Post-authorisation measure (PAM) assessed by CATUpdated
19/04/2024 Document: Timetable: Initial (full) marketing authorisation application accelerated assessment timetablesUpdated
19/04/2024 Document: Timetable: Informed consent and multiple applicationUpdated
19/04/2024 Document: Timetable: Initial (full) marketing authorisation application assessmentUpdated
19/04/2024 PSUSA: PSUSA/00010752/202308 - periodic safety update report single assessmentNew
18/04/2024 Document: Timetable: Initial (full) marketing authorisation application accelerated assessment timetables - Advanced therapy medicinal product (ATMP)Updated
18/04/2024 Document: Timetable: Extension applicationUpdated
18/04/2024 Document: Timetable accelerated assessment request for initial marketing authorisation applicationsUpdated
18/04/2024 Document: Timetable: Extension application - ATMPUpdated
18/04/2024 Medicine: Sitagliptin / Metformin hydrochloride MylanUpdated
18/04/2024 Document: Timetable: Companion diagnostic initial consultation - ATMPUpdated
18/04/2024 Medicine: InflectraUpdated
18/04/2024 Medicine: LenvimaUpdated
18/04/2024 Medicine: CystagonUpdated
18/04/2024 Medicine: PonvoryUpdated
18/04/2024 Medicine: KisplyxUpdated
18/04/2024 Medicine: AyvakytUpdated
18/04/2024 Medicine: AlymsysUpdated
18/04/2024 Medicine: JavlorUpdated
18/04/2024 Document: Timetable: Accelerated assessment request for initial marketing authorisations - ATMPUpdated
18/04/2024 Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - March 2024Updated
18/04/2024 Page: European Shortages Monitoring PlatformNew
18/04/2024 Medicine: MenQuadfiUpdated
18/04/2024 Medicine: BetmigaUpdated
18/04/2024 Document: Draft template for assessment report for the development of European herbal monographs and European Union list entries - Revision 6New
18/04/2024 Document: Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1New
18/04/2024 Medicine: ZinplavaUpdated
18/04/2024 Medicine: KinzalkombUpdated
18/04/2024 Medicine: Dabigatran Etexilate Leon FarmaUpdated
18/04/2024 Document: Timetable: Initial (full) marketing authorisation application accelerated assessment timetables - Advanced therapy medicinal product (ATMP)Updated
18/04/2024 Event: Clinical Trials Information System (CTIS): Walk-in clinic - May 2024Updated
18/04/2024 Medicine: TakhzyroUpdated
17/04/2024 Document: Medicinal products for human use: monthly figures - March 2024New
17/04/2024 Document: Timetable: Companion diagnostic follow-up consultationUpdated
17/04/2024 Document: Timetable: Companion diagnostic follow-up consultation - ATMPUpdated
17/04/2024 Document: Timetable: Companion diagnostic initial consultationUpdated
17/04/2024 Medicine: XolairUpdated
17/04/2024 PSUSA: PSUSA/00010444/202309 - periodic safety update report single assessmentNew
17/04/2024 PSUSA: PSUSA/00009201/202308 - periodic safety update report single assessmentNew
17/04/2024 PIP: EMEA-002981-PIP01-21 - paediatric investigation planUpdated
17/04/2024 Medicine: TalzennaUpdated
17/04/2024 Event: EMA/FVE info session on restrictions for the use of certain antimicrobials in animalsUpdated
17/04/2024 Medicine: TepkinlyUpdated
17/04/2024 Medicine: OcalivaUpdated
17/04/2024 Medicine: OrserduUpdated
17/04/2024 Medicine: VenclyxtoUpdated
17/04/2024 News: COVID-19 vaccine strain updates: Global regulators agree on timing and data requirementsNew
17/04/2024 Page: International Coalition of Medicines Regulatory Authorities (ICMRA)Updated
16/04/2024 Medicine: GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.)Updated
16/04/2024 Medicine: OrkambiUpdated
16/04/2024 Medicine: Briviact (in Italy: Nubriveo)Updated
16/04/2024 Page: Paediatric investigation plans: submitting documentsUpdated
16/04/2024 Medicine: EntyvioUpdated
16/04/2024 Medicine: EvrenzoUpdated
16/04/2024 Medicine: VeozaUpdated
16/04/2024 Event: EMA traineeship programme informative sessionNew
16/04/2024 Medicine: Zoonotic Influenza Vaccine SeqirusUpdated
16/04/2024 Page: Clinical Trials Information System: training and supportUpdated
16/04/2024 Event: Clinical Trials Information System Webinar: Last Year of TransitionUpdated
16/04/2024 Document: Final Minutes – HMA-EMA joint Big Data Steering Group teleconference - 26 February 2024Updated
16/04/2024 Event: Committee for Advanced Therapies (CAT): 17-19 April 2024Updated
16/04/2024 Event: ACT EU Clinical Trials Analytics Workshop - January 2024Updated
16/04/2024 Event: Committee for Orphan Medicinal Products (COMP): 16-18 April 2024Updated
16/04/2024 Event: Simultaneous National Scientific Advice - information and training webinar Updated
16/04/2024 Document: Organisation chart: Advisory functionsUpdated
16/04/2024 Document: Organisation chart: Stakeholders and CommunicationUpdated
15/04/2024 Document: Template - Application for transfer of marketing authorisation from transferor to transferee, cover letterUpdated
15/04/2024 PSUSA: PSUSA/00010224/202308 - periodic safety update report single assessmentNew
15/04/2024 PSUSA: PSUSA/00010242/202308 - periodic safety update report single assessmentNew
15/04/2024 PSUSA: PSUSA/00003151/202308 - periodic safety update report single assessmentNew
15/04/2024 PSUSA: PSUSA/00000435/202308 - periodic safety update report single assessmentNew
15/04/2024 PSUSA: PSUSA/00002322/202308 - periodic safety update report single assessmentNew
15/04/2024 PSUSA: PSUSA/00002392/202308 - periodic safety update report single assessmentNew
15/04/2024 PSUSA: PSUSA/00003012/202308 - periodic safety update report single assessmentNew
15/04/2024 Medicine: XevudyUpdated
15/04/2024 Medicine: TranslarnaUpdated
15/04/2024 PSUSA: PSUSA/00002834/202308 - periodic safety update report single assessmentNew
15/04/2024 PSUSA: PSUSA/00000986/202309 - periodic safety update report single assessmentNew
15/04/2024 Medicine: ScemblixUpdated
15/04/2024 Medicine: JakaviUpdated
15/04/2024 Medicine: VargatefUpdated
15/04/2024 Medicine: XospataUpdated
15/04/2024 Medicine: HoloclarUpdated
15/04/2024 Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working PartyUpdated
15/04/2024 Herbal: Pilosellae herba cum radice - herbal medicinal productUpdated
15/04/2024 Herbal: Eucalypti aetheroleum - herbal medicinal productUpdated
15/04/2024 Page: Template for a European Union herbal monographUpdated
15/04/2024 Document: Template for a European Union herbal monographNew
12/04/2024 Event: Committee for Advanced Therapies (CAT) meeting with interested parties, May 2023New
12/04/2024 Medicine: DarzalexUpdated
12/04/2024 Medicine: ZeposiaUpdated
12/04/2024 Event: Cancer Medicines Forum: February 2024New
12/04/2024 Page: Big dataUpdated
12/04/2024 Document: Guidance on real-world evidence provided by EMA: support for regulatory decision-makingNew
12/04/2024 Document: Minutes of the 122nd meeting of the Management Board, 13-14 December 2023New
12/04/2024 PSUSA: PSUSA/00002506/202308 - periodic safety update report single assessmentNew
12/04/2024 PSUSA: PSUSA/00000858/202307 - periodic safety update report single assessmentNew
12/04/2024 PSUSA: PSUSA/00001850/202307 - periodic safety update report single assessmentNew
12/04/2024 PSUSA: PSUSA/00001040/202307 - periodic safety update report single assessmentNew
12/04/2024 PSUSA: PSUSA/00003134/202305 - periodic safety update report single assessmentNew
12/04/2024 Medicine: EladynosUpdated
12/04/2024 News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2024New
12/04/2024 PSUSA: PSUSA/00002411/202303 - periodic safety update report single assessmentNew
12/04/2024 PSUSA: PSUSA/00010178/202308 - periodic safety update report single assessmentNew
12/04/2024 Page: Pharmaceutical quality of inhalation and nasal products - Scientific guidelineUpdated
12/04/2024 Document: Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal productsNew
12/04/2024 Document: Draft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossierNew
12/04/2024 Document: Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)New
11/04/2024 PIP: EMEA-000727-PIP01-09-M07 - paediatric investigation planUpdated
11/04/2024 Medicine: WegovyUpdated
11/04/2024 Medicine: RybelsusUpdated
11/04/2024 Medicine: OzempicUpdated
11/04/2024 PSUSA: PSUSA/00001392/202308 - periodic safety update report single assessmentNew
11/04/2024 Orphan: EU/3/16/1714 - orphan designation for treatment of mucopolysaccharidosis type IUpdated
11/04/2024 Orphan: EU/3/14/1236 - orphan designation for treatment of epidermolysis bullosaUpdated
11/04/2024 Document: Membership list: HMA-EMA joint Big Data Steering GroupUpdated
11/04/2024 Orphan: EU/3/23/2873 - orphan designation for treatment of tenosynovial giant cell tumour, localised and diffuse typeUpdated
11/04/2024 Orphan: EU/3/17/1861 - orphan designation for treatment of pulmonary arterial hypertensionUpdated
11/04/2024 Orphan: EU/3/22/2723 - orphan designation for treatment of ovarian cancerUpdated
11/04/2024 Orphan: EU/3/20/2265 - orphan designation for treatment of acute myeloid leukaemiaUpdated
11/04/2024 Orphan: EU/3/15/1515 - orphan designation for treatment of cutaneous T-cell lymphomaUpdated
11/04/2024 Orphan: EU/3/19/2184 - orphan designation for treatment of neurofibromatosis type 1Updated
11/04/2024 Orphan: EU/3/05/317 - orphan designation for treatment of graft-versus-host diseaseUpdated
11/04/2024 Medicine: YorvipathUpdated
11/04/2024 Orphan: EU/3/10/756 - orphan designation for prevention of scarring post glaucoma filtration surgeryUpdated
11/04/2024 Orphan: EU/3/20/2311 - orphan designation for treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodesUpdated
11/04/2024 Orphan: EU/3/20/2319 - orphan designation for treatment of long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiencyUpdated
11/04/2024 Orphan: EU/3/18/2010 - orphan designation for treatment of spinal muscular atrophyUpdated
11/04/2024 Event: Focus group on veterinary pharmacovigilance reporting in aquacultureUpdated
11/04/2024 Medicine: MyclausenUpdated
11/04/2024 Orphan: EU/3/17/1938 - orphan designation for treatment of epidermolysis bullosaUpdated
11/04/2024 Orphan: EU/3/18/2080 - orphan designation for treatment of haemophilia BUpdated
11/04/2024 Medicine: Febuxostat Viatris (previously Febuxostat Mylan)Updated
11/04/2024 Orphan: EU/3/24/2897 - orphan designation for treatment of focal segmental glomerulosclerosisNew
11/04/2024 Medicine: Lacosamide UCBUpdated
11/04/2024 Orphan: EU/3/24/2901 - orphan designation for treatment of fibrodysplasia ossificans progressivaNew
11/04/2024 Event: Clinical Trials Information System (CTIS): Walk-in clinic - March 2024Updated
11/04/2024 Orphan: EU/3/24/2890 - orphan designation for treatment of ovarian cancerNew
11/04/2024 Orphan: EU/3/24/2892 - orphan designation for treatment of small cell lung cancerNew
11/04/2024 Medicine: CellCeptUpdated
11/04/2024 Orphan: EU/3/24/2891 - orphan designation for treatment of gliomaNew
11/04/2024 Orphan: EU/3/24/2899 - orphan designation for treatment of acute respiratory distress syndrome (ARDS)New
11/04/2024 Medicine: PadcevUpdated
11/04/2024 Orphan: EU/3/24/2898 - orphan designation for treatment of hereditary angioedemaNew
11/04/2024 Orphan: EU/3/24/2900 - orphan designation for treatment of AL amyloidosisNew
11/04/2024 Orphan: EU/3/24/2896 - orphan designation for treatment of ATTR amyloidosisNew
11/04/2024 Event: Eighth Industry Standing Group (ISG) meetingUpdated
11/04/2024 Orphan: EU/3/23/2887 - orphan designation for treatment of recurrent respiratory papillomatosisNew
11/04/2024 Orphan: EU/3/23/2888 - orphan designation for treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome)New
11/04/2024 Orphan: EU/3/23/2881 - orphan designation for treatment of acute myeloid leukaemiaNew
11/04/2024 Orphan: EU/3/23/2877 - orphan designation for treatment of amyotrophic lateral sclerosisNew
11/04/2024 Orphan: EU/3/23/2884 - orphan designation for treatment of Rett syndromeNew
11/04/2024 Orphan: EU/3/23/2883 - orphan designation for alpha-thalassaemia X-linked intellectual disability syndrome (due to mutations in the ATRX gene)New
11/04/2024 Orphan: EU/3/23/2876 - orphan designation for treatment of small cell lung cancerNew
11/04/2024 Medicine: GlivecUpdated
11/04/2024 Medicine: Fampridine AccordUpdated
11/04/2024 Medicine: XromiUpdated
11/04/2024 Medicine: Entecavir Viatris (previously Entecavir Mylan)Updated
11/04/2024 Orphan: EU/3/23/2885 - orphan designation for treatment of patients undergoing haematopoietic stem cell transplantationNew
11/04/2024 Orphan: EU/3/23/2889 - orphan designation for treatment of thalassaemia intermedia and majorNew
11/04/2024 Orphan: EU/3/23/2875 - orphan designation for diagnosis of gliomaNew
11/04/2024 Orphan: EU/3/23/2879 - orphan designation for treatment of insulinomaNew
11/04/2024 Orphan: EU/3/23/2882 - orphan designation for treatment of eosinophilic granulomatosis with polyangiitisNew
11/04/2024 Orphan: EU/3/23/2878 - orphan designation for treatment of diffuse large B-cell lymphomaNew
11/04/2024 Orphan: EU/3/23/2886 - orphan designation for treatment of acquired factor X deficiencyNew
11/04/2024 Orphan: EU/3/23/2874 - orphan designation for treatment of systemic sclerosisNew
11/04/2024 Orphan: EU/3/24/2894 - orphan designation for treatment of cystic fibrosisNew
11/04/2024 Event: Cancer Medicines Forum workshop: April 2024Updated
11/04/2024 Medicine: Gardasil 9Updated
11/04/2024 Medicine: ZaltrapUpdated
11/04/2024 Medicine: Ambrisentan MylanUpdated
11/04/2024 Medicine: TessieUpdated
11/04/2024 Page: Scientific publicationsUpdated
10/04/2024 Medicine: MyfenaxUpdated
10/04/2024 Medicine: Mycophenolate mofetil TevaUpdated
10/04/2024 Medicine: Ranexa (previously Latixa)Updated
10/04/2024 Document: Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA)Updated
10/04/2024 Medicine: Cancidas (previously Caspofungin MSD)Updated
10/04/2024 Medicine: GavretoUpdated
10/04/2024 Medicine: NivestimUpdated
10/04/2024 Medicine: Abilify MaintenaUpdated
10/04/2024 Medicine: SarclisaUpdated
10/04/2024 Medicine: KyprolisUpdated
10/04/2024 Medicine: AerinazeUpdated
09/04/2024 Medicine: NinlaroUpdated
09/04/2024 Medicine: TepadinaUpdated
09/04/2024 Medicine: DupixentUpdated
09/04/2024 Event: Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRISUpdated
09/04/2024 Page: Variations not requiring assessment (veterinary medicines)Updated
09/04/2024 Event: Focus group on veterinary pharmacovigilance reporting in poultryUpdated
09/04/2024 Orphan: EU/3/18/2090 - orphan designation for treatment of haemophilia BUpdated
09/04/2024 Orphan: EU/3/10/830 - orphan designation for treatment of ovarian cancerUpdated
09/04/2024 Orphan: EU/3/14/1265 - orphan designation for treatment of ovarian cancerUpdated
09/04/2024 Orphan: EU/3/11/902 - orphan designation for treatment of neuroblastomaUpdated
09/04/2024 Orphan: EU/3/16/1808 - orphan designation for treatment of systemic sclerosisUpdated
09/04/2024 Orphan: EU/3/20/2334 - orphan designation for treatment of aspartylglucosaminuriaUpdated
09/04/2024 Orphan: EU/3/16/1736 - orphan designation for treatment of cystic fibrosisUpdated
09/04/2024 Orphan: EU/3/18/2070 - orphan designation for treatment of dermatomyositisUpdated
09/04/2024 Orphan: EU/3/20/2324 - orphan designation for treatment of von Hippel-Lindau diseaseUpdated
09/04/2024 Orphan: EU/3/20/2309 - orphan designation for treatment of idiopathic pulmonary fibrosisUpdated
09/04/2024 Orphan: EU/3/09/632 - orphan designation for treatment of acute intermittent porphyriaUpdated
09/04/2024 Orphan: EU/3/12/974 - orphan designation for treatment of primary hyperoxaluria type 1Updated
09/04/2024 Orphan: EU/3/09/663 - orphan designation for treatment of Duchenne muscular dystrophyUpdated
09/04/2024 Orphan: EU/3/16/1631 - orphan designation for diagnosis of gliomaUpdated
09/04/2024 Orphan: EU/3/16/1632 - orphan designation for diagnosis of hepatocellular carcinomaUpdated
09/04/2024 Orphan: EU/3/22/2593 - orphan designation for treatment of phenylalanine hydroxylase deficiencyUpdated
09/04/2024 Orphan: EU/3/20/2341 - orphan designation for treatment of Fabry diseaseUpdated
09/04/2024 Orphan: EU/3/18/2015 - orphan designation for treatment of haemophilia AUpdated
09/04/2024 Orphan: EU/3/20/2326 - orphan designation for treatment of Gaucher diseaseUpdated
09/04/2024 Medicine: KomboglyzeUpdated
09/04/2024 Medicine: MyozymeUpdated
09/04/2024 Medicine: BraftoviUpdated
09/04/2024 Document: Minutes of the PRAC meeting 5-8 February 2024New
08/04/2024 Medicine: BondronatUpdated
08/04/2024 Medicine: BonvivaUpdated
08/04/2024 Medicine: XydalbaUpdated
08/04/2024 Orphan: EU/3/19/2135 - orphan designation for treatment of DiGeorge syndromeUpdated
08/04/2024 Orphan: EU/3/19/2136 - orphan designation for treatment of CHARGE syndromeUpdated
08/04/2024 Orphan: EU/3/21/2568 - orphan designation for prevention of bronchopulmonary dysplasiaUpdated
08/04/2024 Orphan: EU/3/19/2183 - orphan designation for treatment of WHIM syndromeUpdated
08/04/2024 Document: Agenda of the PRAC meeting 8-11 April 2024New
08/04/2024 Orphan: EU/3/20/2271 - orphan designation for treatment in haematopoietic stem cell transplantationUpdated
08/04/2024 Orphan: EU/3/15/1534 - orphan designation for treatment of Rett syndromeUpdated
08/04/2024 Orphan: EU/3/15/1529 - orphan designation for treatment of fragile X syndromeUpdated
08/04/2024 Orphan: EU/3/19/2203 - orphan designation for treatment of Netherton syndromeUpdated
08/04/2024 Orphan: EU/3/19/2214 - orphan designation for treatment of soft tissue sarcomaUpdated
08/04/2024 Orphan: EU/3/21/2511 - orphan designation for treatment of Krabbe diseaseUpdated
08/04/2024 Orphan: EU/3/16/1759 - orphan designation for treatment of Duchenne muscular dystrophyUpdated
08/04/2024 Orphan: EU/3/21/2563 - orphan designation for treatment of invasive ScopulariopsisUpdated
08/04/2024 Orphan: EU/3/12/978 - orphan designation for treatment of perinatal asphyxiaUpdated
08/04/2024 Orphan: EU/3/21/2407 - orphan designation for treatment of cystinosisUpdated
08/04/2024 Orphan: EU/3/21/2449 - orphan designation for treatment of pulmonary arterial hypertensionUpdated
08/04/2024 Orphan: EU/3/07/434 - orphan designation for treatment of Leber's hereditary optic neuropathyUpdated
08/04/2024 Orphan: EU/3/20/2354 - orphan designation for treatment of microvillus inclusion diseaseUpdated
08/04/2024 Orphan: EU/3/22/2606 - orphan designation for treatment of haemophilia AUpdated
08/04/2024 Orphan: EU/3/19/2232 - orphan designation for treatment of amyotrophic lateral sclerosisUpdated
08/04/2024 Orphan: EU/3/22/2715 - orphan designation for treatment of spinocerebellar ataxiaUpdated
08/04/2024 Medicine: ViagraUpdated
08/04/2024 Page: Contacts at the European Medicines AgencyUpdated
08/04/2024 Page: Services and databasesUpdated
08/04/2024 Medicine: EnjaymoUpdated
08/04/2024 News: EMA systems disruption expected from 11 to 17 AprilNew
08/04/2024 Post-authorisation: Orencia - withdrawal of application for variation to marketing authorisationUpdated
08/04/2024 PIP: EMEA-001821-PIP01-15-M06 - paediatric investigation planUpdated
08/04/2024 PIP: EMEA-002063-PIP01-16-M02 - paediatric investigation planUpdated
08/04/2024 PIP: EMEA-002070-PIP01-16-M07 - paediatric investigation planUpdated
08/04/2024 PIP: EMEA-002079-PIP01-16-M03 - paediatric investigation planUpdated
08/04/2024 PIP: EMEA-003170-PIP01-21-M01 - paediatric investigation planUpdated
08/04/2024 Medicine: CibinqoUpdated
05/04/2024 PIP: EMEA-000334-PIP01-08-M11 - paediatric investigation planUpdated
05/04/2024 PIP: EMEA-000576-PIP01-09-M14 - paediatric investigation planUpdated
05/04/2024 PIP: EMEA-000997-PIP01-10-M06 - paediatric investigation planUpdated
05/04/2024 PIP: EMEA-001220-PIP01-11-M07 - paediatric investigation planUpdated
05/04/2024 PIP: EMEA-003238-PIP01-22 - paediatric investigation planNew
05/04/2024 PIP: EMEA-003241-PIP01-22 - paediatric investigation planNew
05/04/2024 PIP: EMEA-003245-PIP01-22 - paediatric investigation planNew
05/04/2024 Medicine: ImfinziUpdated
05/04/2024 PIP: EMEA-003317-PIP02-22 - paediatric investigation planNew
05/04/2024 Medicine: AspaveliUpdated
05/04/2024 Medicine: StrimvelisUpdated
05/04/2024 PIP: EMEA-003032-PIP01-21-M01 - paediatric investigation planUpdated
05/04/2024 Medicine: LonsurfUpdated
05/04/2024 Medicine: PerjetaUpdated
05/04/2024 PIP: EMEA-001809-PIP01-15-M03 - paediatric investigation planUpdated
05/04/2024 PIP: EMEA-001744-PIP01-14-M02 - paediatric investigation planUpdated
05/04/2024 PIP: EMEA-001734-PIP01-14-M06 - paediatric investigation planUpdated
05/04/2024 PIP: EMEA-001332-PIP01-12-M06 - paediatric investigation planUpdated
05/04/2024 PIP: EMEA-001429-PIP01-13-M07 - paediatric investigation planUpdated
05/04/2024 PIP: EMEA-003237-PIP01-22 - paediatric investigation planUpdated
05/04/2024 PIP: EMEA-003218-PIP01-22 - paediatric investigation planUpdated
05/04/2024 PIP: EMEA-003171-PIP01-21 - paediatric investigation planUpdated
05/04/2024 PIP: EMEA-001371-PIP03-22 - paediatric investigation planNew
05/04/2024 PIP: P/0096/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for pembrolizumab (Keytruda), (EMEA-001474-PIP03-22) - paediatric investigation planNew
05/04/2024 Event: Third European Medicines Agency and Affordable Medicines Europe bilateral meetingNew
05/04/2024 Document: Traineeship - Frequently asked questions (FAQs)Updated
05/04/2024 PIP: EMEA-002690-PIP02-22 - paediatric investigation planNew
05/04/2024 PIP: EMEA-003166-PIP01-21 - paediatric investigation planNew
05/04/2024 PIP: EMEA-003215-PIP01-22 - paediatric investigation planNew
05/04/2024 Medicine: InstanylUpdated
04/04/2024 Page: Transfer of marketing authorisation: questions and answersUpdated
04/04/2024 Document: List of industry subject matter experts and list of planned calls for industry subject matter expertsUpdated
04/04/2024 PSUSA: PSUSA/00002307/202306 - periodic safety update report single assessmentNew
04/04/2024 PSUSA: PSUSA/00001711/202307 - periodic safety update report single assessmentNew
04/04/2024 Referral: Pseudoephedrine-containing medicinal products - referralUpdated
04/04/2024 Medicine: NiapelfNew
04/04/2024 Medicine: OpdivoUpdated
04/04/2024 Medicine: Prevenar 13Updated
04/04/2024 Medicine: Abiraterone MylanUpdated
04/04/2024 Event: Paediatric Committee (PDCO): 20-23 February 2024Updated
04/04/2024 PSUSA: PSUSA/00002655/202306 - periodic safety update report single assessmentNew
04/04/2024 PSUSA: PSUSA/00001713/202212 - periodic safety update report single assessmentNew
04/04/2024 PSUSA: PSUSA/00001356/202212 - periodic safety update report single assessmentNew
04/04/2024 PSUSA: PSUSA/00002664/202211 - periodic safety update report single assessmentNew
04/04/2024 Medicine: KeytrudaUpdated
04/04/2024 Medicine: PecFentUpdated
04/04/2024 Document: Day 80 assessment report - Clinical template with guidance - Rev.04.24 RevampUpdated
04/04/2024 Medicine: EffentoraUpdated
04/04/2024 Medicine: DovatoUpdated
04/04/2024 Medicine: VfendUpdated
04/04/2024 Page: Assessment templates and guidanceUpdated
04/04/2024 PSUSA: PSUSA/00003002/202306 - periodic safety update report single assessmentNew
04/04/2024 Page: Reflection papers on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) - Scientific guidelineUpdated
03/04/2024 Document: List of medicines currently in PRIME schemeUpdated
03/04/2024 Medicine: RubracaUpdated
03/04/2024 Medicine: SixmoUpdated
03/04/2024 Medicine: Ertapenem SUNUpdated
03/04/2024 Medicine: Bovilis Nasalgen-CUpdated
03/04/2024 Medicine: Sorafenib AccordUpdated
03/04/2024 Medicine: Levodopa/Carbidopa/Entacapone OrionUpdated
03/04/2024 Medicine: RevestiveUpdated
03/04/2024 Medicine: YuflymaUpdated
03/04/2024 Event: Committee for Orphan Medicinal Products (COMP): 13-15 February 2024Updated
03/04/2024 PSUSA: PSUSA/00002256/202307 - periodic safety update report single assessmentNew
03/04/2024 Medicine: AbecmaUpdated
03/04/2024 Page: Marketing authorisation templatesUpdated
02/04/2024 Medicine: Celdoxome pegylated liposomalUpdated
02/04/2024 Medicine: SutentUpdated
02/04/2024 Medicine: PedmarqsiUpdated
02/04/2024 Medicine: PylclariUpdated
02/04/2024 Page: Data protection and privacyUpdated
02/04/2024 Page: Medical devicesUpdated
02/04/2024 Medicine: LocametzUpdated
02/04/2024 Medicine: Teriparatide SunUpdated
02/04/2024 PSUSA: PSUSA/00002165/202306 - periodic safety update report single assessmentNew
02/04/2024 Medicine: CometriqUpdated
02/04/2024 Orphan: EU/3/08/610 - orphan designation for treatment of medullary thyroid carcinomaUpdated
02/04/2024 Herbal: Verbasci flos - herbal medicinal productUpdated
02/04/2024 Herbal: Vitis viniferae folium - herbal medicinal productUpdated
02/04/2024 Page: Procedures for monograph and list entry establishmentUpdated
02/04/2024 Herbal: Oenotherae oleum - herbal medicinal productUpdated
02/04/2024 Herbal: Uvae ursi folium - herbal medicinal productUpdated
02/04/2024 Herbal: Melissae folium - herbal medicinal productUpdated
02/04/2024 Herbal: Myrrha - herbal medicinal productUpdated
02/04/2024 Herbal: Meliloti herba - herbal medicinal productUpdated
02/04/2024 Herbal: Cynarae folium - herbal medicinal productUpdated
02/04/2024 Herbal: Curcumae longae rhizoma - herbal medicinal productUpdated
02/04/2024 Medicine: MetalyseUpdated
02/04/2024 Document: List of signals discussed at PRAC since September 2012Updated