Neonatal Medicines Approved in the EU (EMA)

• 47medicines authorised in the EU (authorised now)

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

• 15Apr2026

  Enflonsia

  Active substance: clesrovimab

  EMEA/H/C/006497
• 27May2024

  Neoatricon

  Active substance: dopamine hydrochloride;Dopamine

  EMEA/H/C/006044
• 19Apr2024

  Celldemic

  Active substance: Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen

  EMEA/H/C/006052
• 16Feb2024

  Vlustozik (previously Ibuprofen Gen.Orph)

  Active substance: Ibuprofen

  EMEA/H/C/006129
• 5Jan2024

  Rystiggo

  Active substance: rozanolixizumab

  EMEA/H/C/005824
• 23Aug2023

  Abrysvo

  Active substance: respiratory syncytial virus vaccine (bivalent, recombinant)

  EMEA/H/C/006027
• 26Jul2023

  Ztalmy

  Active substance: ganaxolone

  EMEA/H/C/005825
• 31Oct2022

  Beyfortus

  Active substance: nirsevimab

  EMEA/H/C/005304
• 13Dec2021

  Vaxneuvance

  Active substance: pneumococcal polysaccharide conjugate vaccine (adsorbed)

  EMEA/H/C/005477
• 17Dec2020

  Libmeldy

  Active substance: atidarsagene autotemcel

  EMEA/H/C/005321
• 19Aug2020

  Gencebok

  Active substance: Caffeine citrate

  EMEA/H/C/005435
• 20Sep2018

  Kigabeq

  Active substance: vigabatrin

  EMEA/H/C/004534
• 24May2018

  Amglidia

  Active substance: glibenclamide

  EMEA/H/C/004379
• 9Feb2018

  Alkindi

  Active substance: hydrocortisone

  EMEA/H/C/004416
• 10Apr2017

  Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau)

  Active substance: chenodeoxycholic acid

  EMEA/H/C/004061

Source: European Medicines Agency, Centrally authorised human medicines (EPAR), authorised now. Retrieved 12 Nov 2026.

• Infant deaths
• Newborn deaths (first 28 days)
• Low-birthweight babies

• Pediatric
• Maternal
• Biologics and biosimilars
• Vaccines
• Hepatitis
• Infectious diseases