In other countries
The same active substances on other registers, the same brand first.
Authorised centrally in the EU
This national listing belongs to a medicine the European Commission authorised for the whole EU.
- PemazyreBrazil · United Medical LtdaSame brand
- PemazyreCanada · 9 MG · Tablet · Incyte CorporationSame brand
- PemazyreCanada · 4.5 MG · Tablet · Incyte CorporationSame brand
- PemazyreCanada · 13.5 MG · Tablet · Incyte CorporationSame brand
- PEMAZYRE 13,5 mg COMPRIMIDOSSpain · 13,5 mg · comprimido · Incyte Biosciences Distribution B.V.Same brand
- PEMAZYRE 4,5 mg COMPRIMIDOSSpain · 4,5 mg · comprimido · Incyte Biosciences Distribution B.V.Same brand
- PEMAZYRE 9 mg COMPRIMIDOSSpain · 9 mg · comprimido · Incyte Biosciences Distribution B.V.Same brand
- PemazyreEuropean Union · Incyte Biosciences Distribution B.V.Same brand
- PemazyreCroatiaSame brand
- PemazyreItaly · Compressa · Incyte Biosciences Distribution B.V.Same brand
- Pemazyre Tablets 13.5 MGSingapore · 13.50 mg · tablet · Specialised Therapeutics Asia Pte LTDSame brand
- Pemazyre Tablets 4.5 MGSingapore · 4.50 mg · tablet · Specialised Therapeutics Asia Pte LTDSame brand
- Pemazyre Tablets 9 MGSingapore · 9.00 mg · tablet · Specialised Therapeutics Asia Pte LTDSame brand
- PemazyreUnited States · 13.5MG, 4.5MG, 9MG · tablet · Incyte CorpSame brand
- PemigatinibUnited States · 4.5MG, 9MG · tablet · Sandoz INCSame form
Documents
The official texts, at the regulator.
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
College ter Beoordeling van Geneesmiddelen, Geneesmiddeleninformatiebank metadata, source update 07-10-2026; downloaded 08-10-2026; factual adaptation.
Licence: Conditional noncreative administrative factual metadata; no dataset-wide CC0 claim · Added 8 Oct 2026
Report an error or request removalCorrections from the holder or the register are welcome.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Active substance
- Pemigatinib
- Dosage form
- Tablet
- Route
- Oraal gebruik
- Register
- Netherlands (CBG-MEB)
- Status
- Authorised
- Status in the register
- Ingeschreven
- Authorised
- 26 Mar 2021
- Registration
- EU/1/21/1535
- Marketing authorisation holder
- Incyte Biosciences Distribution B.V.
- ATC code
- L01EN02
- Procedure
- EU centralised
- Supply
- Uitsluitend recept
- EMA product number
- EMEA/H/C/005266
- EU number
- EU/1/21/1535