|
Product class:
|
Authorized package
|
|
Medicinal product class:
|
For human use
|
|
Package code:
|
1503683
|
|
Name of medicinal product:
|
RUCONEST
|
|
Active substances:
|
|
|
ATC code:
|
B06AC04
|
|
Dosage form:
|
powder for solution for injection
|
|
Route of administration:
|
intravenous use
|
|
Strengh:
|
2100ühik
|
|
Amount in package:
|
1TK
|
|
Legal status for supply*:
|
Subject to medicinal prescription
|
|
Class of active substance:
|
|
|
Additional information:
|
|
|
Indication:
|
Ruconest is indicated for treatment of acute angioedema attacks in adults, adolescents, and children (aged
2 years and above) with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency.
|
|
Safety features:
|
Yes
|
|
Summary of product characteristics (SPC):
|
|
|
Package information leaflet (PIL):
|
EST
|
|
Labelling:
|
|
|
Last imported to Estonia:
|
December 15, 2020
|
|
Marketing authorization holder:
|
Pharming Group N.V.
|
|
Marketing authorization number:
|
EU/1/10/641
|
|
Marketing authorization issued on:
|
October 28, 2010
|
|
Marketing authorization expires on:
|
Unlimited
|
|
Marketing authorization procedure type:
|
Centralised
|
|
Reference price:
|
|
|
Under reference price:
|
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
May 19, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader fromhere