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Medicines
Spain
Gemcitabine

AEMPS 2021

Gemcitabine

Gemcitabina Koanaa 200 MG Concentrado Para Solucion Para Perfusion

43,28 mg/ml concentrado para solución para perfusiónSpainAuthorisedAuthorised 24 Feb 2021

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.

Gemcitabine Sandoz Concentrate for Solution for Infusion 40mg/mlSingapore · 40mg/ml · infusion, solution concentrate · Sandoz Singapore Pte. LTD.Same strength and form
Gemcitabine-Teva Concentrate for Solution for Infusion 40MG/MLSingapore · 40mg/ml · infusion, solution concentrate · Teva Pharmaceutical Investments Singapore Pte. LTD.Same strength and form
Gemita® Concentrate for Solution for Infusion 38MG/MLSingapore · 38mg/ml · infusion, solution concentrate · Fresenius Kabi (Singapore) Pte LTDSame strength and form
Gemcitabina AccordItaly · Concentrato per soluzione per infusione · Accord Healthcare, S.L.U.Same form
Gemcitabina Aurobindo Pharma ItaliaItaly · Concentrato per soluzione per infusione · Eugia Pharma (Malta) LimitedSame form

More with the same substance on this register

Gemcitabina Accord 1000 MG Concentrado Para Solucion Para PerfusionGemcitabine · 100 mg · concentrado para solución para perfusiónSpain
GEMCITABINA ACCORD 1500 mg CONCENTRADO PARA SOLUCION PARA PERFUSIONGemcitabine · 100 mg · concentrado para solución para perfusión

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.

Gemcitabina HikmaItaly · Polvere per soluzione per infusione endovenosa · Hikma Farmaceutica (Portugal) S.A.

Same form

🇳🇱Gemcitabine 1000 mg PCH, poeder voor oplossing voor infusieNetherlands · Poeder voor oplossing voor infusie · Pharmachemie B.V.Same form

🇳🇱Gemcitabine 200 mg PCH, poeder voor oplossing voor infusieNetherlands · Poeder voor oplossing voor infusie · Pharmachemie B.V.Same form

🇳🇱Gemcitabine Accord 100 mg/ml Concentraat voor Oplossing voor InfusieNetherlands · Concentraat voor oplossing voor infusie · Accord Healthcare B.V.Same form

🇳🇿DBL GemcitabineNew Zealand · Inj 43.3 mg per ml (equivalent to 38 mg per ml gemcitabine), 26.3 ml vialSame form

🇳🇿Gemcitabine EbeweNew Zealand · Inj 1 gSame form

🇸🇦CITABOL 1000 mg powder for solution for infusionSaudi Arabia · Venus Remedies LimitedSame form

🇸🇦CITABOL 200 mg powder for solution for infusionSaudi Arabia · Venus Remedies LimitedSame form

🇸🇦Citarox 1000MG VialSaudi Arabia · S.C Sindan pharma SRLSame form

🇺🇸Gemcitabine HydrochlorideUnited States · 1GM BASE/VIAL, 1GM/26.3ML, 200MG BASE/VIAL … · injectable · Hospira INCSame form

🇺🇸GemzarUnited States · 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable · LillySame form

🇺🇸GemcitabineUnited States · 200MG, 2G · injectable · Teva ParenteralSame form

🇨🇦Gemcitabine InjectionCanada · 38 MG / ML · Solution · Pfizer Canada UlcSame substance

🇨🇦Gemcitabine InjectionCanada · 40 MG / ML · Solution · Sandoz Canada IncorporatedSame substance

🇨🇦Gemcitabine InjectionCanada · 38 MG / ML · Solution · Apotex INCSame substance

🇭🇷Gemcitabin Accord 100 mg/ml koncentrat za otopinu za infuzijuCroatia · koncentrat za otopinu za infuziju · Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, PoljskaSame substance

🇭🇷Gemcitabin Sandoz 40 mg/ml koncentrat za otopinu za infuzijuCroatia · koncentrat za otopinu za infuziju · Sandoz d.o.o., Maksimirska 120, Zagreb, HrvatskaSame substance

🇷🇴GEMCIRENA 38 mg/mlRomania · 38mg/ml · pulb. pt. sol. perf. · Fresenius Kabi Romania S.R.L.Same substance

🇷🇴GEMCITABINA ACCORD 100mg/mlRomania · 100mg/ml · conc. pt. sol. perf. · Accord Healthcare LimitedSame substance

🇷🇴GEMCITABINA ACORD 100 mg/mlRomania · 100 mg/ml · conc. pt. sol. perf. · Accord Healthcare Polska SP Z.O.O.Same substance

🇷🇸Gemcitabin Ebewe®Serbia · 40mg/mL · koncentrat za rastvor za infuziju · PredstavniŠTvo Sandoz Pharmaceuticals D.D. BeogradSame substance

🇷🇸Gemcitabin Ebewe®Serbia · 40mg/mL · koncentrat za rastvor za infuziju · PredstavniŠTvo Sandoz Pharmaceuticals D.D. BeogradSame substance

🇷🇸Gemcitabine CorapharmSerbia · 200mg · prašak za rastvor za infuziju · Corapharm D.O.O.Same substance

Packs

Pack	Code	Status
GEMCITABINA KOANAA 200 MG CONCENTRADO PARA SOLUCION PARA PERFUSION, 1 vial de 5,26 ml	730466

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: Gemcitabine
Strength: 43,28 mg/ml
Dosage form: concentrado para solución para perfusión
Route: vía intravenosa
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 24 Feb 2021
Registration: 85802
Marketing authorisation holder: Koanaa Healthcare Gmbh
Procedure: National, MRP or DCP
Supply: Uso Hospitalario

🇪🇸Spain

AEMPSGEMCITABINA ACCORD 200 mg CONCENTRADO PARA SOLUCION PARA PERFUSIONGemcitabine · 100 mg · concentrado para solución para perfusión🇪🇸Spain

AEMPSGEMCITABINA ACCORD 2000 mg CONCENTRADO PARA SOLUCION PARA PERFUSIONGemcitabine · 100 mg · concentrado para solución para perfusión🇪🇸Spain

AEMPSGemcitabina Aurovitas Spain 1000 MG Concentrado Para Solucion Para PerfusionGemcitabine · 45,6 mg · concentrado para solución para perfusión🇪🇸Spain

AEMPSGemcitabina Aurovitas Spain 2000 MG Concentrado Para Solucion Para PerfusionGemcitabine · 45,6 mg · concentrado para solución para perfusión🇪🇸Spain

AEMPSGemcitabina Hikma 1000 MG Concentrado Para Solucion Para PerfusionGemcitabine · 1140 mg · concentrado para solución para perfusión🇪🇸Spain

AEMPSGemcitabina Hikma 200 MG Concentrado Para Solucion Para PerfusionGemcitabine · 228 mg · concentrado para solución para perfusión🇪🇸Spain

AEMPSGemcitabina Hikma 2000 MG Concentrado Para Solucion Para PerfusionGemcitabine · 2280 mg · concentrado para solución para perfusión🇪🇸Spain

AEMPSGEMCITABINA HOSPIRA 1000 mg CONCENTRADO PARA SOLUCION PARA PERFUSIONGemcitabine · 38 mg · concentrado para solución para perfusión🇪🇸Spain

AEMPSGEMCITABINA HOSPIRA 200 mg CONCENTRADO PARA SOLUCION PARA PERFUSIONGemcitabine · 38 mg · concentrado para solución para perfusión🇪🇸Spain

AEMPSGEMCITABINA HOSPIRA 2000 mg CONCENTRADO PARA SOLUCION PARA PERFUSIONGemcitabine · 38 mg · concentrado para solución para perfusión🇪🇸Spain