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ELAPRASE
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1279986
Name of medicinal product:
ELAPRASE
Active substances:
Idursulfase
Estonian
,
English
,
Latin
ATC code:
A16AB09
Dosage form:
concentrate for solution for infusion
Route of administration:
intravenous use
Strengh:
2mg 1ml
Amount in package:
3ml 10TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in the clinical trials.
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:
Takeda Pharmaceuticals International AG Ireland Branch
Marketing authorization number:
EU/1/06/365
Marketing authorization issued on:
January 8, 2007
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Centralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: May 2, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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