Topotecan

HYCAMTIN 4 mg POLVO CONCENTRADO PARA SOLUCION PARA PERFUSION

4 mg polvo para concentrado para solución para perfusiónSpainMarketedAuthorised 28 Feb 1997

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Topotecan

HYCAMTIN 4 mg POLVO CONCENTRADO PARA SOLUCION PARA PERFUSION

4 mg polvo para concentrado para solución para perfusiónSpainMarketedAuthorised 28 Feb 1997

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Hycamtin 4 mg, poeder voor infusievloeistof 4 mgNetherlands · Poeder voor oplossing voor injectie · Sandoz Pharmaceuticals d.d.

Hycamtin 0,25mg, Capsule, hardNetherlands · Capsule, hard · Sandoz Pharmaceuticals d.d.

Hycamtin 4MG I.V. VialSaudi Arabia · Glaxo Smithkline Manufacturing S.P.A.

HycamtinUnited States · 4MG BASE/VIAL · injectable · Sandoz

HycamtinUnited States · 0.25MG BASE, 1MG BASE · capsule · Sandoz

PotactasolItaly · Polvere per soluzione per infusione endovenosa · Actavis Group PTC Ehf

Topotecan AhclItaly · Concentrato per soluzione per infusione · Accord Healthcare, S.L.U.

Topotecan HydrochlorideUnited States · 4MG BASE/VIAL · injectable · Sagent Pharms

Cloridrato de TopotecanaBrazil · Accord Farmacêutica Ltda

Teva-TopotecanCanada · 4 MG / VIAL · Powder For Solution · Teva Canada Limited

Topotecan Hydrochloride for InjectionCanada · 1 MG / ML · Solution · Pfizer Canada Ulc

PotactasolEuropean Union · Actavis Group PTC ehf

Topotecan HospiraEuropean Union · Pfizer Europe MA EEIG

Topotekan Alpha-Medical 4 mg prašak za koncentrat za otopinu za infuzijuCroatia · prašak za koncentrat za otopinu za infuziju · Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska

PotactasolCroatia

TOPOTECAN ACCORD 1 mg/mlRomania · 1 mg/ml · conc. pt. sol. perf. · Accord Healthcare Polska SP Z.O.O.

Topotecan HospiraSaudi Arabia · Zydas Hospira Oncology Private Limited (Zhopl)

Packs

Pack	Code	Status
HYCAMTIN 4 mg POLVO CONCENTRADO PARA SOLUCION PARA PERFUSION, 5 viales	658518

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.

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: Topotecan
Strength: 4 mg
Dosage form: polvo para concentrado para solución para perfusión
Route: vía intravenosa
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 28 Feb 1997
Registration: 96027001
Marketing authorisation holder: Sandoz Pharmaceuticals D.D.
Procedure: EU centralised
Supply: Uso Hospitalario

Spain

HYCAMTIN 0,25 mg CAPSULAS DURASTopotecan · 0,25 mg · cápsula duraSpain

HYCAMTIN 1 mg CAPSULAS DURASTopotecan · 1 mg · cápsula duraSpain

TOPOTECAN ACTAVIS 1mg POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFGTopotecan · 1 mg · polvo para concentrado para solución para perfusiónSpainWithdrawn

TOPOTECAN ACTAVIS 4 mg POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFGTopotecan · 4 mg · polvo para concentrado para solución para perfusiónSpainWithdrawn

Topotecan Farmalider 4 MG Polvo Para Concentrado Para Solucion Para Perfusion EfgTopotecan · 4,35 mg · polvo para concentrado para solución para perfusiónSpainWithdrawn