Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1846087
Name of medicinal product: SOGROYA
Active substances:
Somapacitan
Estonian, English, Latin
ATC code: H01AC07
Dosage form: solution for injection in pre-filled pen
Route of administration: subcutaneous use
Strengh: 10mg 1.5ml
Amount in package: 1.5ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
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: 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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: February 23, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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