Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1873975
Name of medicinal product: SKYTROFA
Active substances:
Lonapegsomatropin
Estonian, English, Latin
ATC code: H01AC80
Dosage form: powder and solvent for solution for injection in cartridge
Route of administration: subcutaneous use
Strengh: 7,6mg
Amount in package: 4TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD]).
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: Ascendis Pharma Endocrinology Division A/S 
Marketing authorization number: EU/1/21/1607 
Marketing authorization issued on: January 11, 2022 
Marketing authorization expires on: January 17, 2027 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: October 27, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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