Pediatric Medicines Approved in the EU (EMA)

Each number has its full source under its own list below.

Medicines authorised in the EU

170 medicines (authorised now). Newest first. Each links to its EMA page.

18Sep2026
Ruxolitinib Viatris
Active substance: ruxolitinib hemifumarate
EMEA/H/C/006618
20Aug2026
Daybu
Active substance: trofinetide
EMEA/H/C/006482
15Jul2026
Vijoice
Active substance: alpelisib
EMEA/H/C/006539
20Apr2026
Ojemda
Active substance: tovorafenib
EMEA/H/C/006140
26Mar2026
Kygevvi
Active substance: doxecitine;Doxribtimine
EMEA/H/C/005119
24Mar2026
Rezurock
Active substance: belumosudil mesilate
EMEA/H/C/006421
8Jan2026
Teizeild
Active substance: teplizumab
EMEA/H/C/005496
24Sep2025
Macitentan Accord
Active substance: macitentan
EMEA/H/C/006524
24Sep2025
Macitentan AccordPharma
Active substance: macitentan
EMEA/H/C/006523
17Sep2025
Usrenty
Active substance: ustekinumab
EMEA/H/C/006794
14Aug2025
Usymro
Active substance: ustekinumab
EMEA/H/C/006467
28Jul2025
Riulvy
Active substance: tegomil fumarate
EMEA/H/C/006427
17Jul2025
Ezmekly
Active substance: mirdametinib
EMEA/H/C/006460
19Jun2025
Sephience
Active substance: sepiapterin
EMEA/H/C/006331
2Jun2025
Ryjunea
Active substance: atropine sulfate
EMEA/H/C/006324