Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1673928
Name of medicinal product: SCENESSE
Active substances:
Afamelanotide
Estonian, English, Latin
ATC code: D02BB02
Dosage form: implant
Route of administration: subcutaneous use
Strengh: 16mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: SCENESSE is indicated for prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
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: Clinuvel Europe Limited 
Marketing authorization number: EU/1/14/969 
Marketing authorization issued on: December 22, 2014 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: December 10, 2019
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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