Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1197301
Name of medicinal product: QUADRAMET
Active substances:
Samarium (153Sm) lexidronam
Estonian, English, Latin
ATC code: V10BX02
Dosage form: solution for injection
Route of administration: intravenous use
Strengh: 1,3GBq 1ml
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: QUADRAMET is indicated for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium [99mTc]-labelled biphosphonates on bone scan. The presence of osteoblastic metastases which take up technetium [99mTc]-labelled biphosphonates should be confirmed prior to therapy.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Last imported to Estonia: August 6, 2020
Marketing authorization holder: Cis Bio International 
Marketing authorization number: EU/1/97/057 
Marketing authorization issued on: February 5, 1998 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Entry/Changing date: November 30, 2012
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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