|
08/05/2026 |
|
New |
|
08/05/2026 |
|
Updated |
|
08/05/2026 |
|
New |
|
08/05/2026 |
|
New |
|
08/05/2026 |
|
Updated |
|
08/05/2026 |
|
Updated |
|
08/05/2026 |
Medicine: Olanzapine Glenmark olanzapine
|
Updated |
|
08/05/2026 |
Medicine: Elebrato Ellipta fluticasone furoate; umeclidinium; vilanterol
|
Updated |
|
08/05/2026 |
Medicine: Trelegy Ellipta fluticasone furoate; umeclidinium; vilanterol
|
Updated |
|
08/05/2026 |
Medicine: Opdivo nivolumab
|
Updated |
|
08/05/2026 |
|
Updated |
|
08/05/2026 |
Medicine: Remsima infliximab
|
Updated |
|
08/05/2026 |
Medicine: Arava leflunomide
|
Updated |
|
08/05/2026 |
|
New |
|
08/05/2026 |
|
Updated |
|
08/05/2026 |
PSUSA: PSUSA/00000448/202508 - periodic safety update report single assessment buclizine / codeine / paracetamol, caffeine / codeine / paracetamol
|
New |
|
08/05/2026 |
Medicine: Genvoya elvitegravir; cobicistat; emtricitabine; tenofovir alafenamide
|
Updated |
|
08/05/2026 |
Medicine: Ixiaro Japanese encephalitis vaccine (inactivated, adsorbed)
|
Updated |
|
08/05/2026 |
Medicine: Gardasil 9 human papillomavirus 9-valent vaccine (recombinant, adsorbed)
|
Updated |
|
08/05/2026 |
Medicine: Loargys pegzilarginase
|
Updated |
|
08/05/2026 |
|
Updated |
|
08/05/2026 |
Medicine: Esbriet pirfenidone
|
Updated |
|
08/05/2026 |
|
Updated |
|
08/05/2026 |
Medicine: Bimzelx bimekizumab
|
Updated |
|
08/05/2026 |
Medicine: Teduglutide Viatris teduglutide
|
Updated |
|
08/05/2026 |
Medicine: Bylvay odevixibat
|
Updated |
|
08/05/2026 |
Medicine: Strimvelis autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence
|
Updated |
|
08/05/2026 |
Medicine: Latuda lurasidone
|
Updated |
|
08/05/2026 |
|
Updated |
|
08/05/2026 |
|
Updated |
|
08/05/2026 |
|
Updated |
|
08/05/2026 |
Medicine: Itovebi inavolisib
|
Updated |
|
08/05/2026 |
|
New |
|
08/05/2026 |
|
Updated |
|
08/05/2026 |
|
New |
|
08/05/2026 |
Medicine: Pomalidomide Viatris pomalidomide
|
Updated |
|
08/05/2026 |
Medicine: Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris emtricitabine; rilpivirine; tenofovir alafenamide
|
Updated |
|
08/05/2026 |
Medicine: Mayzent siponimod
|
Updated |
|
08/05/2026 |
PIP: EMEA-001976-PIP02-18 - paediatric investigation plan 3-[5-[(1R,2S)-2-(2,2-difluoropropanoylamino)-1-(2,3-dihydro-1,4-benzodioxin-6-yl)propoxy]indazol-1- yl]-N-[(3R)-tetrahydrofuran-3-yl]benzamide (AZD7594)
|
Updated |
|
08/05/2026 |
PIP: EMEA-001017-PIP01-10-M01 - paediatric investigation plan chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis
|
Updated |
|
08/05/2026 |
|
Updated |
|
08/05/2026 |
PIP: EMEA-001013-PIP01-10-M01 - paediatric investigation plan chemically modified extract of trees pollen from birch and alder
|
Updated |
|
08/05/2026 |
PIP: EMEA-001011-PIP01-10-M01 - paediatric investigation plan chemically modified house dust mites allergen extract of Dermatophagoides pteronyssinus and Dermatophagoides farina
|
Updated |
|
08/05/2026 |
PIP: EMEA-001374-PIP01-12 - paediatric investigation plan exon 53 specific phosphorothioate oligonucleotide
|
Updated |
|
08/05/2026 |
PIP: EMEA-001369-PIP01-12 - paediatric investigation plan exon 45 specific phosphorothioate oligonucleotide
|
Updated |
|
08/05/2026 |
Medicine: Nintedanib Viatris nintedanib
|
Updated |
|
08/05/2026 |
|
Updated |
|
08/05/2026 |
Medicine: Kanjinti trastuzumab
|
Updated |
|
08/05/2026 |
Medicine: Teizeild teplizumab
|
Updated |
|
08/05/2026 |
|
New |
|
08/05/2026 |
Medicine: Dupixent dupilumab
|
Updated |
|
08/05/2026 |
|
New |
|
07/05/2026 |
Medicine: Mysildecard sildenafil
|
Updated |
|
07/05/2026 |
|
Updated |
|
07/05/2026 |
|
Updated |
|
07/05/2026 |
Medicine: Eltrombopag Viatris eltrombopag
|
Updated |
|
07/05/2026 |
|
Updated |
|
07/05/2026 |
|
Updated |
|
07/05/2026 |
Medicine: Ibandronic Acid Sandoz ibandronic acid
|
Updated |
|
07/05/2026 |
Medicine: Dapagliflozin Viatris dapagliflozin
|
Updated |
|
07/05/2026 |
|
Updated |
|
07/05/2026 |
Medicine: Rapilysin reteplase
|
Updated |
|
07/05/2026 |
Medicine: Afiveg aflibercept
|
Updated |
|
07/05/2026 |
|
Updated |
|
07/05/2026 |
Medicine: Loqtorzi toripalimab
|
Updated |
|
07/05/2026 |
Medicine: Humira adalimumab
|
Updated |
|
07/05/2026 |
|
Updated |
|
07/05/2026 |
Medicine: Ilumetri tildrakizumab
|
Updated |
|
07/05/2026 |
Medicine: Comtan entacapone
|
Updated |
|
07/05/2026 |
Medicine: Arixtra fondaparinux sodium
|
Updated |
|
07/05/2026 |
|
Updated |
|
07/05/2026 |
Medicine: Fintepla fenfluramine
|
Updated |
|
07/05/2026 |
Medicine: Uzpruvo ustekinumab
|
Updated |
|
07/05/2026 |
Medicine: Dimethyl fumarate Mylan dimethyl fumarate
|
Updated |
|
07/05/2026 |
Medicine: Beovu brolucizumab
|
Updated |
|
07/05/2026 |
Medicine: Truvelog Mix 30 insulin aspart
|
Updated |
|
07/05/2026 |
|
New |
|
07/05/2026 |
|
Updated |
|
07/05/2026 |
Medicine: CellCept mycophenolate mofetil
|
Updated |
|
07/05/2026 |
Medicine: Uplizna inebilizumab
|
Updated |
|
07/05/2026 |
Medicine: Olumiant baricitinib
|
Updated |
|
07/05/2026 |
Medicine: Kerendia finerenone
|
Updated |
|
07/05/2026 |
|
Updated |
|
07/05/2026 |
Medicine: Oncaspar pegaspargase
|
Updated |
|
07/05/2026 |
|
Updated |
|
07/05/2026 |
|
New |
|
07/05/2026 |
|
New |
|
07/05/2026 |
|
New |
|
07/05/2026 |
Medicine: Usgena ustekinumab
|
Updated |
|
06/05/2026 |
|
Updated |
|
06/05/2026 |
|
New |
|
06/05/2026 |
Shortage: NexoBrid concentrate of proteolytic enzymes enriched in bromelain
|
New |
|
06/05/2026 |
Medicine: Tolucombi telmisartan; hydrochlorothiazide
|
Updated |
|
06/05/2026 |
|
Updated |
|
06/05/2026 |
PIP: EMA/PE/0000290054 - paediatric investigation plan human polyclonal immunoglobulin G against thymocyte
|
New |
|
06/05/2026 |
|
New |
|
06/05/2026 |
Medicine: Integrilin eptifibatide
|
Updated |
|
06/05/2026 |
PIP: EMEA-002414-PIP01-18 - paediatric investigation plan Humanized anti-CD19, Fc engineered, monoclonal antibody (XmAb5871)
|
Updated |
|
06/05/2026 |
|
Updated |
|
06/05/2026 |
Medicine: Imcivree setmelanotide
|
Updated |
|
06/05/2026 |
Medicine: Korjuny catumaxomab
|
Updated |
|
06/05/2026 |
Medicine: Truqap capivasertib
|
Updated |
|
06/05/2026 |
|
Updated |
|
06/05/2026 |
Medicine: Irbesartan Teva irbesartan
|
Updated |
|
06/05/2026 |
Medicine: Ogsiveo nirogacestat
|
Updated |
|
05/05/2026 |
Medicine: Rhapsido remibrutinib
|
Updated |
|
05/05/2026 |
|
Updated |
|
05/05/2026 |
|
Updated |
|
05/05/2026 |
|
New |
|
05/05/2026 |
|
New |
|
05/05/2026 |
|
New |
|
05/05/2026 |
|
Updated |
|
05/05/2026 |
|
Updated |
|
05/05/2026 |
Medicine: Bimervax COVID-19 Vaccine (recombinant, adjuvanted)
|
Updated |
|
05/05/2026 |
Medicine: Onerji levodopa; carbidopa
|
Updated |
|
05/05/2026 |
Medicine: Palsonify paltusotine
|
Updated |
|
05/05/2026 |
Medicine: Ilaris canakinumab
|
Updated |
|
05/05/2026 |
|
Updated |
|
05/05/2026 |
Medicine: Mvabea Ebola vaccine (MVA-BN-Filo [recombinant])
|
Updated |
|
05/05/2026 |
Medicine: Zabdeno ebola vaccine (Ad26.ZEBOV-GP [recombinant])
|
Updated |
|
05/05/2026 |
Medicine: Qutenza capsaicin
|
Updated |
|
05/05/2026 |
Medicine: Comirnaty COVID-19 mRNA vaccine
|
Updated |
|
04/05/2026 |
|
Updated |
|
04/05/2026 |
|
Updated |
|
04/05/2026 |
|
Updated |
|
04/05/2026 |
|
New |
|
04/05/2026 |
|
New |
|
04/05/2026 |
|
Updated |
|
04/05/2026 |
|
New |
|
04/05/2026 |
|
Updated |
|
04/05/2026 |
|
Updated |
|
04/05/2026 |
|
Updated |
|
04/05/2026 |
|
Updated |
|
04/05/2026 |
Medicine: Leqembi lecanemab
|
Updated |
|
04/05/2026 |
Medicine: Rapamune sirolimus
|
Updated |
|
04/05/2026 |
Medicine: Yeytuo lenacapavir
|
Updated |
|
04/05/2026 |
|
Updated |
|
04/05/2026 |
|
Updated |
|
04/05/2026 |
|
New |
|
04/05/2026 |
|
New |