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Medicines
Spain
Axitinib

AEMPS 2024

Axitinib

Axitinib Teva 5 MG Comprimidos Recubiertos con Pelicula Efg

5 mg comprimido recubierto con películaSpainMarketedAuthorised 19 Jul 2024

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

InlytaCanada · 1 MG · Tablet · Pfizer Canada UlcSame form
InlytaCanada · 5 MG · Tablet · Pfizer Canada UlcSame form
InlytaCanada · 3 MG · Tablet · Pfizer Canada UlcSame 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

More with the same substance on this register

Axitinib Accord 1 MG Comprimidos Recubiertos con Pelicula EfgAxitinib · 1 mg · comprimido recubierto con películaSpain
Axitinib Accord 3 MG Comprimidos Recubiertos con Pelicula EfgAxitinib · 3 mg · comprimido recubierto con película

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

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

🇳🇱Axitinib Accord 1 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Accord Healthcare S.L.U.Same form

🇳🇱Axitinib Accord 3 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Accord Healthcare S.L.U.Same form

🇳🇱Axitinib Accord 5 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Accord Healthcare S.L.U.Same form

🇳🇿InlytaNew Zealand · Tab 5 mgSame form

🇳🇿InlytaNew Zealand · Tab 1 mgSame form

🇷🇸Axitinib STADASerbia · 1mg · film tableta · Hemofarm Ad VRŠAcSame form

🇷🇸Axitinib STADASerbia · 1mg · film tableta · Hemofarm Ad VRŠAcSame form

🇷🇸Axitinib STADASerbia · 5mg · 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

Packs

Pack	Code	Status
AXITINIB TEVA 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG, 56 comprimidos	765300

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 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
Strength: 5 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 19 Jul 2024
Registration: 89675
Marketing authorisation holder: Teva Gmbh
Procedure: National, MRP or DCP
Supply: Uso Hospitalario

🇪🇸Spain

AEMPSAxitinib Accord 5 MG Comprimidos Recubiertos con Pelicula EfgAxitinib · 5 mg · comprimido recubierto con película🇪🇸Spain

AEMPSAxitinib Stada 1 MG Comprimidos Recubiertos con Pelicula EfgAxitinib · 1 mg · comprimido recubierto con película🇪🇸Spain

AEMPSAxitinib Stada 5 MG Comprimidos Recubiertos con Pelicula EfgAxitinib · 5 mg · comprimido recubierto con película🇪🇸Spain

AEMPSAxitinib Teva 1 MG Comprimidos Recubiertos con Pelicula EfgAxitinib · 1 mg · comprimido recubierto con película🇪🇸Spain

AEMPSInlyta 1 MG Comprimidos Recubiertos con PeliculaAxitinib · 1,00 mg · comprimido recubierto con película🇪🇸Spain

AEMPSInlyta 5 MG Comprimidos Recubiertos con PeliculaAxitinib · 5,00 mg · comprimido recubierto con película🇪🇸Spain