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CERDELGA
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1713675
Name of medicinal product:
CERDELGA
Active substances:
Eliglustat
Estonian
,
English
,
Latin
ATC code:
A16AX10
Dosage form:
capsule, hard
Route of administration:
oral use
Strengh:
84mg
Amount in package:
14TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1), who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).
Safety features:
Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL):
EST
Labelling:
Last imported to Estonia:
Never imported to Estonia
:
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions
to State Agency of Medicines
.
State Agency of Medicines
Marketing authorization
Marketing authorization holder:
Genzyme Europe B.V.
Marketing authorization number:
EU/1/14/974
Marketing authorization issued on:
January 19, 2015
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Centralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: January 2, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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