Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1044627
Name of medicinal product: HYCAMTIN
Active substances:
Topotecan
Estonian, English, Latin
ATC code: L01CE01
Dosage form: powder for concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 4mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Topotecan monotherapy is indicated for the treatment of: - patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. - patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1). Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination (see section 5.1).
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: October 14, 2010
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: EU/1/96/027 
Marketing authorization issued on: December 17, 1999 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: January 23, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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