|
20/01/2026 |
|
Updated |
|
20/01/2026 |
|
Updated |
|
20/01/2026 |
Medicine: Aflunov zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
|
Updated |
|
20/01/2026 |
Medicine: Daptomycin Hospira daptomycin
|
Updated |
|
20/01/2026 |
Medicine: Evrysdi risdiplam
|
Updated |
|
20/01/2026 |
|
Updated |
|
20/01/2026 |
|
Updated |
|
20/01/2026 |
|
Updated |
|
20/01/2026 |
|
Updated |
|
20/01/2026 |
Medicine: Degevma denosumab
|
Updated |
|
20/01/2026 |
Medicine: Ponlimsi denosumab
|
Updated |
|
20/01/2026 |
|
Updated |
|
20/01/2026 |
|
New |
|
20/01/2026 |
|
Updated |
|
20/01/2026 |
|
Updated |
|
20/01/2026 |
|
New |
|
19/01/2026 |
Medicine: Abiraterone Mylan abiraterone acetate
|
Updated |
|
19/01/2026 |
Medicine: Xenpozyme olipudase alfa
|
Updated |
|
19/01/2026 |
Medicine: Effentora fentanyl
|
Updated |
|
19/01/2026 |
Medicine: Brintellix vortioxetine
|
Updated |
|
19/01/2026 |
Medicine: Wegovy semaglutide
|
Updated |
|
19/01/2026 |
|
Updated |
|
19/01/2026 |
|
New |
|
19/01/2026 |
|
Updated |
|
19/01/2026 |
Medicine: Opuviz aflibercept
|
Updated |
|
19/01/2026 |
Medicine: Rybelsus semaglutide
|
Updated |
|
19/01/2026 |
|
New |
|
19/01/2026 |
Medicine: Darzalex daratumumab
|
Updated |
|
19/01/2026 |
Medicine: Imuldosa ustekinumab
|
Updated |
|
19/01/2026 |
|
Updated |
|
19/01/2026 |
Medicine: Relistor methylnaltrexone bromide
|
Updated |
|
19/01/2026 |
Medicine: Zercepac trastuzumab
|
Updated |
|
19/01/2026 |
|
New |
|
19/01/2026 |
Medicine: Skyrizi risankizumab
|
Updated |
|
19/01/2026 |
Medicine: Tagrisso osimertinib
|
Updated |
|
19/01/2026 |
Medicine: Ziagen abacavir
|
Updated |
|
19/01/2026 |
Medicine: Trizivir abacavir; lamivudine; zidovudine
|
Updated |
|
19/01/2026 |
Medicine: Kivexa abacavir; lamivudine
|
Updated |
|
19/01/2026 |
Medicine: Teduglutide Viatris teduglutide
|
Updated |
|
19/01/2026 |
|
Updated |
|
19/01/2026 |
|
Updated |
|
19/01/2026 |
|
New |
|
19/01/2026 |
|
New |
|
19/01/2026 |
|
Updated |
|
19/01/2026 |
Medicine: Aprovel irbesartan
|
Updated |
|
19/01/2026 |
|
New |
|
16/01/2026 |
|
Updated |
|
16/01/2026 |
Medicine: Rystiggo rozanolixizumab
|
Updated |
|
16/01/2026 |
Medicine: Namuscla mexiletine hcl
|
Updated |
|
16/01/2026 |
|
New |
|
16/01/2026 |
|
New |
|
16/01/2026 |
PSUSA: PSUSA/00001128/202505 - periodic safety update report single assessment diphtheria / tetanus vaccines (adsorbed), diphtheria vaccines (adsorbed)
|
New |
|
16/01/2026 |
|
New |
|
16/01/2026 |
|
New |
|
16/01/2026 |
|
New |
|
16/01/2026 |
|
New |
|
16/01/2026 |
|
New |
|
16/01/2026 |
Medicine: Kerendia finerenone
|
Updated |
|
16/01/2026 |
Medicine: Sugammadex Adroiq sugammadex
|
Updated |
|
16/01/2026 |
Medicine: Ervebo Ebola Zaire vaccine (rVSV∆G-ZEBOV-GP, live)
|
Updated |
|
16/01/2026 |
Medicine: Elrexfio elranatamab
|
Updated |
|
16/01/2026 |
Medicine: Aripiprazole Zentiva aripiprazole
|
Updated |
|
16/01/2026 |
Medicine: Intuniv guanfacine
|
Updated |
|
16/01/2026 |
Medicine: Alimta pemetrexed
|
Updated |
|
16/01/2026 |
|
Updated |
|
16/01/2026 |
Medicine: Xospata gilteritinib
|
Updated |
|
16/01/2026 |
|
New |
|
16/01/2026 |
Medicine: Terrosa teriparatide
|
Updated |
|
16/01/2026 |
Medicine: Karvea irbesartan
|
Updated |
|
16/01/2026 |
Medicine: Tauvid flortaucipir (18F)
|
Updated |
|
16/01/2026 |
|
Updated |
|
16/01/2026 |
Medicine: Cyramza ramucirumab
|
Updated |
|
16/01/2026 |
Medicine: Amyvid florbetapir (18F)
|
Updated |
|
16/01/2026 |
Medicine: Abiraterone Krka abiraterone acetate
|
Updated |
|
16/01/2026 |
|
New |
|
16/01/2026 |
Medicine: Lotilaner / Milbemycin Elanco lotilaner; milbemycin oxime
|
New |
|
16/01/2026 |
Referral: Oxbryta - referral voxelotor
|
Updated |
|
16/01/2026 |
Medicine: Victoza liraglutide
|
Updated |
|
16/01/2026 |
Medicine: Ifirmacombi irbesartan; hydrochlorothiazide
|
Updated |
|
16/01/2026 |
Medicine: Irbesartan/Hydrochlorothiazide Teva irbesartan; hydrochlorothiazide
|
Updated |
|
16/01/2026 |
Medicine: Rivastigmine 1 A Pharma rivastigmine
|
Updated |
|
16/01/2026 |
Medicine: Rivastigmine Hexal rivastigmine
|
Updated |
|
16/01/2026 |
Medicine: Rivastigmine Sandoz rivastigmine
|
Updated |
|
16/01/2026 |
|
New |
|
16/01/2026 |
|
Updated |
|
16/01/2026 |
|
New |
|
16/01/2026 |
|
New |
|
16/01/2026 |
|
New |
|
16/01/2026 |
|
Updated |
|
15/01/2026 |
|
New |
|
15/01/2026 |
|
New |
|
15/01/2026 |
|
Updated |
|
15/01/2026 |
|
New |
|
15/01/2026 |
|
New |
|
15/01/2026 |
|
New |
|
15/01/2026 |
|
New |
|
15/01/2026 |
|
New |
|
15/01/2026 |
|
New |
|
15/01/2026 |
|
New |
|
15/01/2026 |
|
New |
|
15/01/2026 |
|
New |
|
15/01/2026 |
PIP: EMEA-003402-PIP01-23 - paediatric investigation plan fibroblast growth factor 21 analogue (NNC194-0499) / semaglutide
|
Updated |
|
15/01/2026 |
|
Updated |
|
15/01/2026 |
|
Updated |
|
15/01/2026 |
Medicine: Verkazia ciclosporin
|
Updated |
|
15/01/2026 |
Medicine: Ikervis ciclosporin
|
Updated |
|
15/01/2026 |
Medicine: Rhokiinsa netarsudil
|
Updated |
|
15/01/2026 |
Medicine: Bekemv eculizumab
|
Updated |
|
15/01/2026 |
Medicine: Roclanda latanoprost / netarsudil
|
Updated |
|
15/01/2026 |
|
New |
|
15/01/2026 |
|
New |
|
15/01/2026 |
|
Updated |
|
15/01/2026 |
Medicine: Ebglyss lebrikizumab
|
Updated |
|
15/01/2026 |
Medicine: Vyvgart efgartigimod alfa
|
Updated |
|
15/01/2026 |
|
Updated |
|
15/01/2026 |
Medicine: Blincyto blinatumomab
|
Updated |
|
15/01/2026 |
|
New |
|
15/01/2026 |
|
Updated |
|
15/01/2026 |
|
Updated |
|
15/01/2026 |
|
Updated |
|
14/01/2026 |
|
New |
|
14/01/2026 |
Medicine: Roctavian valoctocogene roxaparvovec
|
Updated |
|
14/01/2026 |
Medicine: Triumeq abacavir; dolutegravir; lamivudine
|
Updated |
|
14/01/2026 |
|
New |
|
14/01/2026 |
Medicine: Otezla apremilast
|
Updated |
|
14/01/2026 |
|
New |
|
14/01/2026 |
Medicine: Yesafili aflibercept
|
Updated |
|
14/01/2026 |
Medicine: Zvogra denosumab
|
Updated |
|
14/01/2026 |
Medicine: Abiraterone Accord abiraterone
|
Updated |
|
14/01/2026 |
Medicine: Stoboclo denosumab
|
Updated |
|
14/01/2026 |
Medicine: Abevmy bevacizumab
|
Updated |
|
14/01/2026 |
Medicine: Nemluvio nemolizumab
|
Updated |
|
14/01/2026 |
Medicine: Rydapt midostaurin
|
Updated |
|
14/01/2026 |
|
Updated |
|
14/01/2026 |
|
Updated |
|
14/01/2026 |
|
Updated |
|
13/01/2026 |
Medicine: Aranesp darbepoetin alfa
|
Updated |
|
13/01/2026 |
Medicine: Welireg belzutifan
|
Updated |
|
13/01/2026 |
Medicine: Mavenclad cladribine
|
Updated |
|
13/01/2026 |
Medicine: Kisunla donanemab
|
Updated |
|
13/01/2026 |
Medicine: Yesintek ustekinumab
|
Updated |
|
13/01/2026 |
Medicine: Besremi ropeginterferon alfa-2b
|
Updated |
|
13/01/2026 |
Medicine: Inrebic fedratinib
|
Updated |
|
13/01/2026 |
Medicine: GalenVita germanium (68Ge) chloride; gallium (68Ga) chloride
|
Updated |
|
13/01/2026 |
|
Updated |
|
13/01/2026 |
Medicine: Winlevi clascoterone
|
Updated |
|
13/01/2026 |
Medicine: Voydeya danicopan
|
Updated |
|
13/01/2026 |
|
Updated |
|
13/01/2026 |
|
Updated |
|
13/01/2026 |
Medicine: Entresto sacubitril; valsartan
|
Updated |
|
13/01/2026 |
Medicine: Neparvis sacubitril; valsartan
|
Updated |
|
12/01/2026 |
PIP: EMA/PE/0000232896 - paediatric investigation plan antisense oligonucleotide against patatin like phospholipase domain containing protein 3 gene (PNPLA3), conjugated to N-acetylgalactosamine (AZD2693), sodium salt
|
Updated |
|
12/01/2026 |
PIP: EMEA-000976-PIP01-10 - paediatric investigation plan Grass pollen allergen extract from Dactylis glomerata L., Anthoxanthum odoratum L., Lolium perenne L., Poa prantensis L. and Phleum pratense L.
|
Updated |
|
12/01/2026 |
|
Updated |
|
12/01/2026 |
Medicine: Celsentri maraviroc
|
Updated |
|
12/01/2026 |
Medicine: Hetronifly serplulimab
|
Updated |
|
12/01/2026 |
|
New |
|
12/01/2026 |
Medicine: Latuda lurasidone
|
Updated |
|
12/01/2026 |
|
Updated |
|
12/01/2026 |
|
New |
|
12/01/2026 |
|
New |
|
12/01/2026 |
|
Updated |
|
12/01/2026 |
|
Updated |
|
12/01/2026 |
|
Updated |
|
12/01/2026 |
|
Updated |
|
12/01/2026 |
Medicine: Libmyris adalimumab
|
Updated |
|
12/01/2026 |
Medicine: Bosulif bosutinib
|
Updated |
|
12/01/2026 |
Medicine: Abilify aripiprazole
|
Updated |
|
12/01/2026 |
Medicine: Xeljanz tofacitinib
|
Updated |
|
12/01/2026 |
|
Updated |
|
12/01/2026 |
Medicine: Tremfya guselkumab
|
Updated |
|
12/01/2026 |
Medicine: Hepcludex bulevirtide
|
Updated |
|
09/01/2026 |
|
Updated |
|
09/01/2026 |
Medicine: Usymro ustekinumab
|
Updated |
|
09/01/2026 |
Medicine: Bilprevda denosumab
|
Updated |
|
09/01/2026 |
Medicine: Tolvaptan Accord tolvaptan
|
Updated |
|
09/01/2026 |
Medicine: Onureg azacitidine
|
Updated |
|
09/01/2026 |
Medicine: Praluent alirocumab
|
Updated |
|
09/01/2026 |
|
New |
|
09/01/2026 |
Medicine: Ayvakyt avapritinib
|
Updated |
|
09/01/2026 |
Medicine: Nurzigma pridopidine
|
Updated |
|
09/01/2026 |
Medicine: Tysabri natalizumab
|
Updated |
|
09/01/2026 |
Medicine: Fintepla fenfluramine
|
Updated |
|
09/01/2026 |
Medicine: Harvoni ledispavir; sofosbuvir
|
Updated |
|
09/01/2026 |
Medicine: Sovaldi sofosbuvir
|
Updated |
|
09/01/2026 |
Medicine: Rimmyrah ranibizumab
|
Updated |
|
08/01/2026 |
|
Updated |
|
08/01/2026 |
|
New |
|
08/01/2026 |
|
Updated |
|
08/01/2026 |
|
New |
|
08/01/2026 |
Medicine: Ecovaxxin MS Mycoplasma synoviae, strain K588A, Live
|
Updated |
|
08/01/2026 |
|
Updated |
|
08/01/2026 |
|
Updated |
|
08/01/2026 |
Medicine: Reagila cariprazine
|
Updated |
|
08/01/2026 |
Medicine: Xalkori crizotinib
|
Updated |
|
08/01/2026 |
|
Updated |
|
08/01/2026 |
Medicine: Wayrilz rilzabrutinib
|
Updated |
|
08/01/2026 |
|
Updated |
|
08/01/2026 |
|
New |
|
07/01/2026 |
Medicine: Cabazitaxel Accord cabazitaxel
|
Updated |
|
07/01/2026 |
Medicine: Rotarix rotavirus vaccine, live
|
Updated |
|
07/01/2026 |
|
Updated |
|
07/01/2026 |
Medicine: Herzuma trastuzumab
|
Updated |
|
07/01/2026 |
|
Updated |
|
07/01/2026 |
Medicine: Norvir ritonavir
|
Updated |
|
07/01/2026 |
|
Updated |
|
07/01/2026 |
Medicine: Dupixent dupilumab
|
Updated |
|
07/01/2026 |
|
Updated |
|
07/01/2026 |
Medicine: Lunsumio mosunetuzumab
|
Updated |
|
07/01/2026 |
Medicine: Vaxxinact H5 Avian influenza virus, subtype H5, haemagglutinin (recombinant)
|
Updated |
|
07/01/2026 |
|
Updated |
|
07/01/2026 |
Medicine: Gazyvaro obinutuzumab
|
Updated |
|
07/01/2026 |
|
Updated |
|
07/01/2026 |
Medicine: Apremilast Accord apremilast
|
Updated |
|
07/01/2026 |
Medicine: Voraxaze glucarpidase
|
Updated |
|
07/01/2026 |
Medicine: Kuvan sapropterin
|
Updated |
|
07/01/2026 |
|
Updated |
|
07/01/2026 |
|
New |
|
07/01/2026 |
|
New |
|
07/01/2026 |
|
New |
|
07/01/2026 |
|
New |
|
07/01/2026 |
Medicine: Trazimera trastuzumab
|
Updated |
|
06/01/2026 |
|
Updated |
|
06/01/2026 |
Medicine: Kapruvia difelikefalin
|
Updated |
|
06/01/2026 |
Medicine: Itovebi inavolisib
|
Updated |
|
06/01/2026 |
|
Updated |
|
06/01/2026 |
Medicine: Obodence denosumab
|
Updated |
|
06/01/2026 |
|
New |
|
06/01/2026 |
|
New |
|
06/01/2026 |
|
New |
|
06/01/2026 |
|
New |
|
06/01/2026 |
|
New |
|
06/01/2026 |
|
New |
|
06/01/2026 |
|
New |
|
06/01/2026 |
|
New |
|
06/01/2026 |
|
New |
|
06/01/2026 |
|
New |
|
06/01/2026 |
|
New |
|
06/01/2026 |
Medicine: Tyverb lapatinib
|
Updated |
|
06/01/2026 |
Medicine: Bildyos denosumab
|
Updated |
|
06/01/2026 |
Medicine: Imlygic talimogene laherparepvec
|
Updated |
|
06/01/2026 |
Medicine: Eltrombopag Viatris eltrombopag
|
Updated |
|
06/01/2026 |
Medicine: Ofev nintedanib
|
Updated |
|
06/01/2026 |
Medicine: Spedra avanafil
|
Updated |
|
06/01/2026 |
|
Updated |
|
06/01/2026 |
Medicine: Vabysmo faricimab
|
Updated |
|
06/01/2026 |
|
Updated |
|
06/01/2026 |
Medicine: Veklury remdesivir
|
Updated |
|
06/01/2026 |
Medicine: Vaxneuvance pneumococcal polysaccharide conjugate vaccine (adsorbed)
|
Updated |
|
06/01/2026 |
Medicine: Efmody hydrocortisone
|
Updated |
|
06/01/2026 |
|
Updated |
|
06/01/2026 |
|
Updated |
|
06/01/2026 |
|
Updated |
|
06/01/2026 |
|
Updated |
|
06/01/2026 |
|
New |
|
05/01/2026 |
Medicine: Levetiracetam Sun levetiracetam
|
Updated |
|
05/01/2026 |
Medicine: Jalra vildagliptin
|
Updated |
|
05/01/2026 |
Medicine: Alymsys bevacizumab
|
Updated |
|
05/01/2026 |
Medicine: Junod denosumab
|
Updated |
|
05/01/2026 |
Medicine: Telzir fosamprenavir
|
Updated |
|
05/01/2026 |
|
Updated |
|
05/01/2026 |
Medicine: Kefdensis denosumab
|
Updated |
|
05/01/2026 |
Medicine: Xiliarx vildagliptin
|
Updated |
|
05/01/2026 |
Medicine: Cablivi caplacizumab
|
Updated |
|
05/01/2026 |
|
New |
|
05/01/2026 |
|
Updated |
|
05/01/2026 |
|
Updated |
|
05/01/2026 |
|
Updated |
|
05/01/2026 |
|
New |