|
Product class:
|
Authorized package
|
|
Medicinal product class:
|
For human use
|
|
Package code:
|
1617184
|
|
Name of medicinal product:
|
LUTATHERA
|
|
Active substances:
|
|
|
ATC code:
|
V10XX04
|
|
Dosage form:
|
solution for infusion
|
|
Route of administration:
|
intravenous use
|
|
Strengh:
|
370MBq 1ml
|
|
Amount in package:
|
20.5ml 1TK
|
|
Legal status for supply*:
|
Subject to medicinal prescription
|
|
Class of active substance:
|
|
|
Additional information:
|
|
|
Indication:
|
Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.
|
|
Safety features:
|
Yes
|
|
Summary of product characteristics (SPC):
|
|
|
Package information leaflet (PIL):
|
EST
|
|
Labelling:
|
|
|
Last imported to Estonia:
|
November 15, 2023
|
|
Marketing authorization holder:
|
Advanced Accelerator Applications
|
|
Marketing authorization number:
|
EU/1/17/1226
|
|
Marketing authorization issued on:
|
September 28, 2017
|
|
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:
September 1, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader fromhere