Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1364598
Name of medicinal product: HYCAMTIN
Active substances:
Topotecan
Estonian, English, Latin
ATC code: L01CE01
Dosage form: capsule, hard
Route of administration: oral use
Strengh: 0,25mg
Amount in package: 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: HYCAMTIN capsules are indicated as monotherapy for the treatment of adult 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).
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: EU/1/96/027 
Marketing authorization issued on: March 18, 2008 
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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