Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1871951
Name of medicinal product: ASPAVELI
Active substances:
Pegcetacoplan
Estonian, English, Latin
ATC code: L04AJ03
Dosage form: solution for infusion
Route of administration: subcutaneous use
Strengh: 1080mg 20ml
Amount in package: 20ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: ASPAVELI is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least 3 months.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: February 1, 2024
: 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 holder: Swedish Orphan Biovitrum AB (publ) 
Marketing authorization number: EU/1/21/1595 
Marketing authorization issued on: December 13, 2021 
Marketing authorization expires on: December 14, 2026 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 6, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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