Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1197301
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Name of medicinal product:
|
QUADRAMET
|
Active substances:
|
|
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
|
Labelling:
|
|
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:
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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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