Is Somapacitan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Somapacitan, including Sogroya 10 mg / 1.5 ml (6.7 mg/ml, Solution for injection, SAR 2048.00); Sogroya 15 mg / 1.5 ml (10 mg/ml, Solution for injection in pre-filled pen, SAR 3072.00); Sogroya 5 mg / 1.5ml (3.3 mg/ml, Solution for injection in pre-filled pen, SAR 1024.00).

Is Somapacitan approved by the US FDA?

Drugs@FDA lists 1 application product line for Somapacitan, including SOGROYA (Prescription).

Is Somapacitan authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Somapacitan: Sogroya.

Are there safety signals or safety updates for Somapacitan?

US FDA: 1 entry (latest 2026-02-27).

Active substance

Somapacitan

SFDA 3
US FDA 1
EMA 1
Health Canada 3
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Sogroya 10 mg / 1.5 ml	6.7 mg/ml	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 2048.00	Biological · Prescription	NOVO NORDISK	Valid
Sogroya 15 mg / 1.5 ml	10 mg/ml	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 3072.00	Biological · Prescription	NOVO NORDISK	Valid
Sogroya 5 mg / 1.5ml	3.3 mg/ml	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 1024.00	Biological · Prescription	NOVO NORDISK	Valid

Indications — CHI Daman Drug Formulary

ADULT GROWTH HORMONE DEFICIENCY; CHILD GROWTH HORMONE DEFICIENCY

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
SOGROYA	10MG/1.5ML	solution · subcutaneous	NOVO NORDISK INC	Prescription	28 Aug 2020

EMA European Union — centrally authorised medicines

Sogroya Novo Nordisk A/S · Authorised · authorised 31 Mar 2021 · ATC H01AC07

Therapeutic indication (EMA)

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).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SOGROYA	02539934	5 MG / 1.5 ML	SOLUTION · SUBCUTANEOUS	NOVO NORDISK CANADA INC
SOGROYA	02539942	10 MG / 1.5 ML	SOLUTION · SUBCUTANEOUS	NOVO NORDISK CANADA INC
SOGROYA	02539950	15 MG / 1.5 ML	SOLUTION · SUBCUTANEOUS	NOVO NORDISK CANADA INC

Safety signals and safety-related labeling changes

US FDA 27 Feb 2026 SOGROYA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for somapacitan →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.