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.
- InlytaCanada · 1 MG · Tablet · Pfizer Canada UlcSame form
- InlytaCanada · 5 MG · Tablet · Pfizer Canada UlcSame form
- InlytaCanada · 7 MG · Tablet · Pfizer Canada UlcSame form
- Axitinib Accord 1 MG Comprimidos Recubiertos con Pelicula EfgSpain · 1 mg · comprimido recubierto con película · Accord Healthcare S.L.U.Same form
- Axitinib Accord 3 MG Comprimidos Recubiertos con Pelicula EfgSpain · 3 mg · comprimido recubierto con película · Accord Healthcare S.L.U.Same form
- Axitinib Accord 5 MG Comprimidos Recubiertos con Pelicula EfgSpain · 5 mg · comprimido recubierto con película · Accord Healthcare S.L.U.Same form
- Aksitinib Alpha-Medical 1 mg filmom obložene tableteCroatia · Filmom obložena tableta · Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, HrvatskaSame form
- Aksitinib Alpha-Medical 5 mg filmom obložene tableteCroatia · Filmom obložena tableta · Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, HrvatskaSame form
- Aksitinib Teva 1 mg filmom obložene tableteCroatia · Filmom obložena tableta · Teva GmbH, Graf-Arco-Strasse 3, Ulm, NjemačkaSame form
- Axitinib AccordItaly · Compressa rivestita con film · Accord Healthcare, S.L.U.Same form
- Axitinib EgItaly · Compressa rivestita con film · Eg S.P.A.Same form
- Axitinib SandozItaly · Compressa rivestita con film · Sandoz S.P.A.Same form
- InlytaNew Zealand · Tab 5 mgSame form
- InlytaNew Zealand · Tab 1 mgSame form
- Axitinib STADASerbia · 3mg · film tableta · Hemofarm Ad VRŠAcSame form
- Axitinib STADASerbia · 3mg · film tableta · Hemofarm Ad VRŠAcSame form
- Axitinib STADASerbia · 1mg · film tableta · Hemofarm Ad VRŠAcSame form
- INLYTA 1 mg film-coated tabletSaudi Arabia · PfizerSame form
- INLYTA 5 mg film-coated tabletSaudi Arabia · PfizerSame form
- Axitinib Sandoz Film Coated Tablet 1 MGSingapore · 1.00 mg · tablet, film coated · Sandoz Singapore Pte. LTD.Same form
- Axitinib Sandoz Film Coated Tablet 5 MGSingapore · 5.00 mg · tablet, film coated · Sandoz Singapore Pte. LTD.Same form
- Inlyta Tablets 1MGSingapore · 1.000mg · tablet, film coated · Pfizer Private LimitedSame form
- InlytaUnited States · 1MG, 5MG · tablet · PF Prism CVSame form
- AxitinibUnited States · 1MG · tablet · Sandoz INCSame form
- AxitinibUnited States · 1MG, 5MG · tablet · Teva PharmsSame form
- InlytaBrazil · Pfizer Brasil LtdaSame substance
- InlytaBrazil · Laboratórios Pfizer LtdaSame substance
- Axitinib AccordEuropean Union · Accord Healthcare S.L.U.Same substance
- InlytaEuropean Union · Pfizer Europe MA EEIGSame substance
- InlytaRomania · 1 mg · compr. film. · Pfizer Europe Ma EeigSame substance
- INLYTA 1 mgRomania · 1mg · compr. film. · Pfizer LimitedSame substance
- INLYTA 5 mgRomania · 5mg · compr. film. · Pfizer LimitedSame substance
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
- Axitinib
- Dosage form
- Filmomhulde tablet
- Route
- Oraal gebruik
- Register
- Netherlands (CBG-MEB)
- Status
- Authorised
- Status in the register
- Ingeschreven
- Authorised
- 19 Sept 2024
- Registration
- EU/1/24/1847
- Marketing authorisation holder
- Accord Healthcare S.L.U.
- ATC code
- L01EK01
- Procedure
- EU centralised
- Supply
- Uitsluitend recept
- EMA product number
- EMEA/H/C/006206
- EU number
- EU/1/24/1847



