Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: SOGROYA
Active substances:
Somapacitan
Estonian, English, Latin
ATC code: H01AC07
Dosage form: solution for injection in pre-filled pen
Strength: 10mg 1.5ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Sogroya is indicated for the replacement of endogenous growth hormone (GH) in children aged 3 years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric GHD), and in adults with growth hormone deficiency (adult 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: Novo Nordisk A/S 
Marketing authorization number: EU/1/20/1501 
Marketing authorization issued on: March 31, 2021 
Marketing authorization expires on: April 6, 2026 
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
1846087  SOGROYA  solution for injection in pre-filled pen  10mg 1.5ml 1.5ml 1TK  Prescription           
1846098  SOGROYA  solution for injection in pre-filled pen  10mg 1.5ml 1.5ml 5TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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