Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1847437
Name of medicinal product: ORLADEYO
Active substances:
Berotralstat
Estonian, English, Latin
ATC code: B06AC06
Dosage form: capsule, hard
Route of administration: oral use
Strengh: 150mg
Amount in package: 28TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
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 holder: BioCryst Ireland Limited 
Marketing authorization number: EU/1/21/1544 
Marketing authorization issued on: April 30, 2021 
Marketing authorization expires on: May 4, 2026 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: May 6, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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