DateContentStatus
17/09/2024 Medicine: Pomalidomide AccordUpdated
17/09/2024 Medicine: KisplyxUpdated
17/09/2024 Medicine: LenvimaUpdated
17/09/2024 Medicine: TrumenbaUpdated
17/09/2024 Medicine: CaprelsaUpdated
17/09/2024 Medicine: KerendiaUpdated
17/09/2024 Medicine: RoctavianUpdated
17/09/2024 Medicine: InflectraUpdated
17/09/2024 Medicine: VemlidyUpdated
17/09/2024 Medicine: MinjuviUpdated
17/09/2024 Document: Agenda - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (18 September 2024)Updated
17/09/2024 Document: Pharmacovigilance Risk Assessment Committee (PRAC) criteria to prioritise impact research (Rev.1)Updated
17/09/2024 Medicine: DexdomitorUpdated
17/09/2024 Event: Joint EC/HMA/EMA multi-stakeholder workshop on pharmacogenomicsUpdated
17/09/2024 Document: Recommended submission dates for veterinary medicinal productsUpdated
17/09/2024 Document: Agenda - Information session on the pilot for expert panels' advice for orphan medical devicesUpdated
16/09/2024 Document: Lidocaine (bovine): European Public MRL Assessment Report (EPMAR) - CVMPUpdated
16/09/2024 Document: Lidocaine (porcine species): European Public MRL Assessment Report (EPMAR) - CVMPUpdated
16/09/2024 Page: Handling competing interestsUpdated
16/09/2024 Document: Decision of the Executive Director on transparency measures for senior staff leaving the AgencyNew
16/09/2024 Document: Joint Committee Opinion 27/2020 on criteria and restrictions for senior staff applying for occupational activities within two years after leaving the AgencyNew
16/09/2024 Page: Establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisationUpdated
16/09/2024 Document: Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation applicationNew
16/09/2024 Document: Guidance for competent authorities on how to highlight VNRAsNew
16/09/2024 Event: Joint HMA/EMA multi-stakeholder workshop on submission predictabilityUpdated
16/09/2024 Medicine: SuliquaUpdated
16/09/2024 Medicine: KalydecoUpdated
16/09/2024 Medicine: TecentriqUpdated
16/09/2024 Event: Translating innovation to access for ATMPs: 3rd EU-Innovation network multi-stakeholder meetingNew
16/09/2024 Document: Agenda of the CHMP meeting 16-19 September 2024New
16/09/2024 Event: Clinical Trials Regulation (CTR) Collaborate Stakeholder meeting, supported by ACT EUUpdated
16/09/2024 Medicine: BonvivaUpdated
16/09/2024 Medicine: BondronatUpdated
16/09/2024 Document: IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicantsUpdated
16/09/2024 Page: Healthcare professionals: Key documentsUpdated
16/09/2024 Document: Early dialogue with healthcare professional organisations for marketing authorisation applications: 1-year reportNew
16/09/2024 Medicine: TremfyaUpdated
16/09/2024 Medicine: PalforziaUpdated
16/09/2024 PIP: EMEA-000574-PIP02-12-M04 - paediatric investigation planUpdated
16/09/2024 PIP: EMEA-001475-PIP03-17-M04 - paediatric investigation planUpdated
16/09/2024 PIP: EMEA-001911-PIP01-15-M05 - paediatric investigation planUpdated
16/09/2024 PIP: EMEA-002826-PIP01-20-M04 - paediatric investigation planUpdated
16/09/2024 Medicine: KeytrudaUpdated
16/09/2024 Event: New fee regulation: webinar for human industry stakeholdersNew
16/09/2024 Medicine: Spikevax (previously COVID-19 Vaccine Moderna)Updated
16/09/2024 News: New chair elected for EMA’s Orphan Medicinal Products CommitteeNew
16/09/2024 Page: Human MedicinesUpdated
16/09/2024 Document: Organisation chart: Human MedicinesUpdated
13/09/2024 Orphan: EU/3/24/2952 - orphan designation for treatment of congenital alpha-1 antitrypsin deficiencyNew
13/09/2024 Orphan: EU/3/24/2958 - orphan designation for treatment of Creutzfeldt-Jakob diseaseNew
13/09/2024 Orphan: EU/3/24/2949 - orphan designation for treatment of peripheral T-cell lymphomaNew
13/09/2024 Orphan: EU/3/24/2957 - orphan designation for treatment of Friedreich's ataxiaNew
13/09/2024 Orphan: EU/3/24/2951 - orphan designation for treatment of spinocerebellar ataxiaNew
13/09/2024 Orphan: EU/3/24/2945 - orphan designation for treatment of primary large B-cell lymphoma of immune-privileged sitesNew
13/09/2024 Orphan: EU/3/24/2954 - orphan designation for treatment of Wolfram syndromeNew
13/09/2024 Orphan: EU/3/24/2956 - orphan designation for treatment of cystic fibrosisNew
13/09/2024 Orphan: EU/3/24/2947 - orphan designation for treatment of variegate porphyriaNew
13/09/2024 Orphan: EU/3/24/2948 - orphan designation for treatment of mitochondrial neurogastrointestinal encephalomyopathy (MNGIE)New
13/09/2024 Orphan: EU/3/24/2946 - orphan designation for treatment of thrombotic thrombocytopenic purpuraNew
13/09/2024 Orphan: EU/3/24/2944 - orphan designation for treatment of non-syndromic inherited retinal dystrophies of the rod-dominant phenotypeNew
13/09/2024 Orphan: EU/3/24/2950 - orphan designation for treatment of hepatocellular carcinomaNew
13/09/2024 Orphan: EU/3/24/2943 - orphan designation for treatment of hepatocellular carcinomaNew
13/09/2024 Orphan: EU/3/24/2955 - orphan designation for treatment of peripheral T-cell lymphomaNew
13/09/2024 Medicine: TauvidUpdated
13/09/2024 Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - September 2024Updated
13/09/2024 Orphan: EU/3/24/2953 - orphan designation for treatment of Prader-Willi syndromeNew
13/09/2024 PIP: EMEA-003316-PIP01-22 - paediatric investigation planNew
13/09/2024 Medicine: RybrevantUpdated
13/09/2024 Medicine: Teriparatide SunUpdated
13/09/2024 PIP: EMEA-003331-PIP02-23 - paediatric investigation planNew
13/09/2024 Medicine: AdenuricUpdated
13/09/2024 PIP: EMEA-003346-PIP01-22 - paediatric investigation planNew
13/09/2024 Medicine: RimmyrahUpdated
13/09/2024 PIP: EMEA-003348-PIP01-22 - paediatric investigation planNew
13/09/2024 PIP: EMEA-003415-PIP01-23 - paediatric investigation planNew
13/09/2024 PIP: EMEA-003418-PIP01-23 - paediatric investigation planNew
13/09/2024 PIP: EMEA-003423-PIP01-23 - paediatric investigation planNew
13/09/2024 PIP: EMEA-003427-PIP01-23 - paediatric investigation planNew
13/09/2024 PIP: EMEA-003427-PIP02-23 - paediatric investigation planNew
13/09/2024 Medicine: ArthriCoxNew
13/09/2024 Medicine: Cirbloc M HyoNew
13/09/2024 News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 September 2024New
13/09/2024 Medicine: FlixabiUpdated
13/09/2024 Medicine: ByoovizUpdated
13/09/2024 PIP: EMEA-003429-PIP01-23 - paediatric investigation planNew
13/09/2024 PIP: EMEA-003429-PIP02-23 - paediatric investigation planNew
13/09/2024 PIP: EMEA-003431-PIP01-23 - paediatric investigation planNew
13/09/2024 PIP: EMEA-002773-PIP01-20-M01 - paediatric investigation planUpdated
13/09/2024 PIP: EMEA-002699-PIP01-19-M01 - paediatric investigation planUpdated
13/09/2024 PIP: EMEA-002677-PIP01-19-M03 - paediatric investigation planUpdated
13/09/2024 PIP: EMEA-002653-PIP01-19-M01 - paediatric investigation planUpdated
13/09/2024 PIP: EMEA-002635-PIP02-21-M02 - paediatric investigation planUpdated
13/09/2024 PIP: EMEA-002342-PIP02-18-M02 - paediatric investigation planUpdated
13/09/2024 PIP: EMEA-002342-PIP01-18-M03 - paediatric investigation planUpdated
13/09/2024 PIP: EMEA-002269-PIP01-17-M02 - paediatric investigation planUpdated
13/09/2024 PIP: EMEA-002214-PIP01-17-M02 - paediatric investigation planUpdated
13/09/2024 PIP: EMEA-002029-PIP01-16-M04 - paediatric investigation planUpdated
13/09/2024 PIP: EMEA-002028-PIP01-16-M04 - paediatric investigation planUpdated
13/09/2024 PIP: EMEA-002012-PIP01-16-M04 - paediatric investigation planUpdated
13/09/2024 PIP: EMEA-001739-PIP02-16-M02 - paediatric investigation planUpdated
13/09/2024 PIP: EMEA-001664-PIP02-15-M06 - paediatric investigation planUpdated
13/09/2024 Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - June 2024Updated
13/09/2024 Document: Minutes – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (26 June 2024)New
12/09/2024 Page: Environmental risk assessment of medicinal products for human use - Scientific guidelineUpdated
12/09/2024 Event: Third European Medicines Agency (EMA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meetingNew
12/09/2024 Event: Second European Medicines Agency and COCIR bilateral meetingNew
12/09/2024 Referral: Ocaliva - referralUpdated
12/09/2024 PSUSA: PSUSA/00001853/202401 - periodic safety update report single assessmentNew
12/09/2024 PSUSA: PSUSA/00000389/202312 - periodic safety update report single assessmentNew
12/09/2024 Medicine: DzuveoUpdated
12/09/2024 Medicine: ToluraUpdated
12/09/2024 Event: New fee regulation: webinar for veterinary industry stakeholdersNew
12/09/2024 Document: European Medicines Agency’s data protection notice for the Referentials Management System (RMS) activitiesNew
12/09/2024 Medicine: VeraSealUpdated
12/09/2024 Medicine: TofidenceUpdated
12/09/2024 Medicine: ResolorUpdated
12/09/2024 Medicine: DupixentUpdated
12/09/2024 Event: Sixth European Medicines Agency - EuropaBio bilateral meetingNew
12/09/2024 Event: Information session on the pilot for expert panels' advice for orphan medical devicesUpdated
12/09/2024 Document: PRIME eligibility requests: 2025 deadlines for submission and timetable for assessmentNew
12/09/2024 PSUSA: PSUSA-00001276-202312 - periodic safety update report single assessmentNew
12/09/2024 Medicine: EvrysdiUpdated
12/09/2024 PSUSA: PSUSA/00001169/232312 - periodic safety update report single assessmentNew
12/09/2024 Medicine: Lopinavir/Ritonavir Viatris (previously Ritonavir Mylan)Updated
12/09/2024 Medicine: XareltoUpdated
12/09/2024 Medicine: RozlytrekUpdated
12/09/2024 Document: Agenda of the Medicine Shortages SPOC Working Party meeting - 11 September 2024New
11/09/2024 Medicine: Nilotinib AccordUpdated
11/09/2024 Medicine: SteqeymaUpdated
11/09/2024 Medicine: Fingolimod AccordUpdated
11/09/2024 Medicine: Ritonavir Viatris (previously Ritonavir Mylan)Updated
11/09/2024 Medicine: Ibandronic acid AccordUpdated
11/09/2024 Medicine: CresembaUpdated
11/09/2024 Document: Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA)Updated
11/09/2024 Document: Timetable: Post-authorisation measures (PAMs) assessed by PRAC - ATMPUpdated
11/09/2024 Document: Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) - Advanced therapy medicinal products (ATMPs)Updated
11/09/2024 Page: Questions and answers on the guideline on the environmental risk assessment of medicinal products for human useUpdated
11/09/2024 Document: Timetable: Safety signal - Assessment of responses to request for supplementary information (RSI) - ATMPUpdated
11/09/2024 Event: Union Product Database webinar for veterinary marketing authorisation holders on an industry-dedicated read APINew
11/09/2024 Medicine: Tadalafil LillyUpdated
11/09/2024 Page: Questions and answers regarding co-processed excipients used in solid oral dosage formsNew
11/09/2024 Document: Questions and answers regarding co-processed excipients used in solid oral dosage forms (H & V)New
11/09/2024 Medicine: CialisUpdated
11/09/2024 Medicine: TalzennaUpdated
11/09/2024 Medicine: Pregabalin Viatris (previously Pregabalin Mylan)Updated
10/09/2024 Document: EMA guidance on the use of medicinal products for treatment and prophylaxis in case of exposure to biological agents used as weapons of terrorism, crime or warfareUpdated
10/09/2024 Document: EMA guidance on the use of medicinal products for treatment in case of exposure to chemical agents used as weapons of terrorism, crime, or warfareUpdated
10/09/2024 Page: Haematology Working PartyUpdated
10/09/2024 Document: Consolidated 3-year rolling work plan for the Haematology Working Party (HAEMWP) : January 2025 - December 2027New
10/09/2024 Page: Oncology Working PartyUpdated
10/09/2024 Document: Consolidated 3-year rolling work plan for the Oncology Working Party : January 2025 - December 2027New
10/09/2024 Page: Rheumatology/Immunology Working PartyUpdated
10/09/2024 Document: Draft 3-year rolling work plan for the Rheumatology and Immunology Working Party (RIWP) : 2025-2027New
10/09/2024 Document: CAT quarterly highlights and approved ATMPs - May-July 2024New
10/09/2024 Page: ProcurementUpdated
10/09/2024 Event: Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 July 2024Updated
10/09/2024 Document: Minutes of the PRAC meeting 8-11 July 2024New
10/09/2024 Medicine: Nobilis Multriva RT+IBm+ND+Gm+REOmUpdated
10/09/2024 Medicine: Nobilis Multriva RT+IBm+ND+EDSUpdated
10/09/2024 PSUSA: PSUSA/00001910/202312 - periodic safety update report single assessmentNew
10/09/2024 PSUSA: PSUSA/00003047/202312 - periodic safety update report single assessmentNew
10/09/2024 PSUSA: PSUSA/00001813/202310 - periodic safety update report single assessmentNew
10/09/2024 PSUSA: PSUSA/00001351/202309 - periodic safety update report single assessmentNew
10/09/2024 PSUSA: PSUSA/00000277/202312 - periodic safety update report single assessmentNew
10/09/2024 Medicine: PrometaxUpdated
10/09/2024 EU-M4all: Fexinidazole WinthropUpdated
10/09/2024 PSUSA: PSUSA/00002797/202312 - periodic safety update report single assessmentNew
10/09/2024 Medicine: AbrysvoUpdated
10/09/2024 Medicine: InstanylUpdated
10/09/2024 Medicine: ImvanexUpdated
10/09/2024 Document: CTIS newsflash - 10 September 2024New
10/09/2024 Document: Membership list: HMA-EMA joint Big Data Steering GroupUpdated
09/09/2024 Medicine: TysabriUpdated
09/09/2024 Medicine: OlumiantUpdated
09/09/2024 Medicine: Nyxthracis (previously Obiltoxaximab SFL)Updated
09/09/2024 Event: Scientific Symposium on Advanced Therapy Medicinal Products - ‘Contribution, evolution, revolution’New
09/09/2024 Event: Info session on web-based electronic Application Form (eAF) add packageUpdated
09/09/2024 Document: Questions and answers - Info session on web-based electronic Application Form (eAF) add packageNew
09/09/2024 Document: Member states contact points for translations reviewUpdated
09/09/2024 Medicine: LytenavaUpdated
09/09/2024 Document: Agenda of the CVMP meeting 10-12 September 2024New
09/09/2024 Medicine: Tadalafil MylanUpdated
09/09/2024 PSUSA: PSUSA/00001662/202401 - periodic safety update report single assessmentNew
09/09/2024 PSUSA: PSUSA/00002487/202401 - periodic safety update report single assessmentNew
09/09/2024 PSUSA: PSUSA/00001596/202401 - periodic safety update report single assessmentNew
09/09/2024 Document: Veterinary pre-submission meeting request form - in accordance with Regulation (EU) No 2019/6Updated
09/09/2024 Event: Committee for Advanced Therapies (CAT): 11-12 September 2024Updated
09/09/2024 Page: Clinical development of medicinal products for the treatment and prevention of bipolar disorderUpdated
09/09/2024 Document: Draft guideline on clinical development of medicinal products for the treatment and prevention of bipolar disorder - Revision 1New
06/09/2024 Page: Scientific publicationsUpdated
06/09/2024 Medicine: Zimbus BreezhalerUpdated
06/09/2024 PSUSA: PSUSA/00001996/202401 - periodic safety update report single assessmentNew
06/09/2024 PSUSA: PSUSA/00000616/202312 - periodic safety update report single assessmentNew
06/09/2024 PSUSA: PSUSA/00002781/202401 - periodic safety update report single assessmentNew
06/09/2024 PSUSA: PSUSA/00009074/202401 - periodic safety update report single assessmentNew
06/09/2024 PSUSA: PSUSA/00002680/202312 - periodic safety update report single assessmentNew
06/09/2024 PSUSA: PSUSA/00000928/202312 - periodic safety update report single assessmentNew
06/09/2024 Document: Applications for new human medicines under evaluation: September 2024New
06/09/2024 Medicine: RystiggoUpdated
06/09/2024 Medicine: RepathaUpdated
06/09/2024 Herbal: Soiae oleum raffinatum - herbal medicinal productUpdated
06/09/2024 Herbal: Mastic - herbal medicinal productUpdated
06/09/2024 Medicine: AspaveliUpdated
06/09/2024 Referral: Lorazepam Macure 4 mg/ml, solution for injection - referralUpdated
06/09/2024 Medicine: EntrestoUpdated
06/09/2024 Medicine: NeparvisUpdated
06/09/2024 Medicine: NoxafilUpdated
06/09/2024 Referral: Metamizole-containing medicinal products - referralUpdated
06/09/2024 Medicine: SaveneUpdated
06/09/2024 Medicine: Ivabradine AccordUpdated
06/09/2024 Medicine: PaxlovidUpdated
06/09/2024 News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2024New
06/09/2024 PSUSA: PSUSA/00010710/202401 - periodic safety update report single assessmentNew
06/09/2024 Medicine: CholestagelUpdated
06/09/2024 PSUSA: PSUSA/00000850/202312 - periodic safety update report single assessmentNew
06/09/2024 Medicine: mResviaUpdated
05/09/2024 Medicine: MultaqUpdated
05/09/2024 Medicine: CamzyosUpdated
05/09/2024 Medicine: MektoviUpdated
05/09/2024 Medicine: BraftoviUpdated
05/09/2024 Medicine: ViagraUpdated
05/09/2024 Medicine: LyxumiaUpdated
05/09/2024 Medicine: BimervaxUpdated
05/09/2024 Medicine: NuvaxovidUpdated
05/09/2024 News: Harnessing AI in medicines regulation: use of large language models (LLMs)New
05/09/2024 Page: Artificial intelligenceUpdated
05/09/2024 Document: Guiding principles on the use of large language models in regulatory science and for medicines regulatory activitiesNew
05/09/2024 Document: Factsheet - four principles for safe and responsible use of large language modelsNew
05/09/2024 Medicine: EurneffyUpdated
05/09/2024 Medicine: Dapagliflozin ViatrisUpdated
05/09/2024 Medicine: Pemetrexed SandozUpdated
05/09/2024 Page: Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)Updated
05/09/2024 Medicine: Pregabalin SandozUpdated
05/09/2024 Medicine: ApexelsinUpdated
05/09/2024 Medicine: AravaUpdated
05/09/2024 Medicine: ReagilaUpdated
05/09/2024 Medicine: BetmigaUpdated
04/09/2024 Medicine: BeyfortusUpdated
04/09/2024 Document: Standard operating procedure for assignment of micro-, small- or medium-sized-enterprise statusUpdated
04/09/2024 Document: Standard operating procedure for renewal of micro-, small- or medium-sized-enterprise statusUpdated
04/09/2024 Medicine: Infanrix HexaUpdated
04/09/2024 Event: Fourth veterinary big data stakeholder forumUpdated
04/09/2024 Page: Plasma master file certificatesUpdated
04/09/2024 Medicine: AbecmaUpdated
04/09/2024 Medicine: BreyanziUpdated
04/09/2024 Medicine: SpravatoUpdated
04/09/2024 Event: Quarterly System Demo – Q3 2024Updated
04/09/2024 Event: EMA multi-stakeholder workshop on qualification of novel methodologiesUpdated
04/09/2024 Medicine: Dovprela (previously Pretomanid FGK)Updated
04/09/2024 Referral: Havrix - referralUpdated
04/09/2024 Medicine: EfientUpdated
04/09/2024 Event: Clinical Trials Information System (CTIS): Walk-in clinic - November 2024New
04/09/2024 Document: Appendix 1: Acceptable intakes established for N-nitrosaminesUpdated
04/09/2024 Document: Rapid alert notification of a quality defect / recallUpdated
04/09/2024 Document: Follow-up and non-urgent information for quality defectsUpdated
04/09/2024 Document: Sponsor's report on the maintenance of the designation criteria at the time of marketing authorisation for a designated orphan-medicinal-productUpdated
04/09/2024 Medicine: Rivastigmine ActavisUpdated
04/09/2024 Medicine: XgevaUpdated
04/09/2024 Medicine: FabrazymeUpdated
04/09/2024 Medicine: PegasysUpdated
03/09/2024 Medicine: Revinty ElliptaUpdated
03/09/2024 Event: Clinical Trials Information System (CTIS): Information dayNew
03/09/2024 Medicine: Relvar ElliptaUpdated
03/09/2024 Medicine: HizentraUpdated
03/09/2024 Medicine: RenvelaUpdated
03/09/2024 Page: ICH guideline E11A on pediatric extrapolation - Scientific guidelineUpdated
03/09/2024 Document: ICH guideline E11A on pediatric extrapolation Step 5Updated
03/09/2024 Medicine: RenagelUpdated
03/09/2024 Medicine: Carmustine medac (previously Carmustine Obvius)Updated
03/09/2024 Medicine: PhesgoUpdated
03/09/2024 Medicine: JevtanaUpdated
03/09/2024 Medicine: VenclyxtoUpdated
03/09/2024 Medicine: Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)Updated
03/09/2024 Document: Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to LabellingUpdated
03/09/2024 PSUSA: PSUSA/00000262/202311 - periodic safety update report single assessmentNew
02/09/2024 Medicine: Pramipexole TevaUpdated
02/09/2024 Medicine: TafinlarUpdated
02/09/2024 DHPC: Ozempic / Victoza - direct healthcare professional communication (DHPC)New
02/09/2024 Event: Paediatric Committee (PDCO): 3-6 September 2024Updated
02/09/2024 Document: Agenda - PDCO agenda of the 3-6 September 2024 meetingNew
02/09/2024 Event: Paediatric Committee (PDCO): 25-28 June 2024Updated
02/09/2024 Document: PDCO minutes of the 25-28 June 2024 meetingNew
02/09/2024 Document: Agenda of the PRAC meeting 2-5 September 2024New
02/09/2024 Medicine: LynparzaUpdated
02/09/2024 Medicine: Toujeo (previously Optisulin)Updated
02/09/2024 Document: Amoxicillin and amoxicillin/clavulanic acid supply shortageUpdated
02/09/2024 Document: European Medicines Agency’s data protection notice for EudraVigilance Human (EV)Updated
02/09/2024 Medicine: JylamvoUpdated
02/09/2024 Medicine: VabysmoUpdated
02/09/2024 Medicine: ImfinziUpdated
02/09/2024 Medicine: LantusUpdated
02/09/2024 Medicine: Olanzapine TevaUpdated
02/09/2024 PSUSA: PSUSA/00001529/202311 - periodic safety update report single assessmentNew