Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: SKYTROFA
Active substances:
Lonapegsomatropin
Estonian, English, Latin
ATC code: H01AC09
Dosage form: powder and solvent for solution for injection in cartridge
Strength: 11mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
: 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 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1873997  SKYTROFA  powder and solvent for solution for injection in cartridge  11mg 4TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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