Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1503683
Name of medicinal product: RUCONEST
Active substances:
Conestat alfa
Estonian, English, Latin
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

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