Is Somatrogon registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Somatrogon, including NGENLA (24 mg, Solution for injection, SAR 795.00); NGENLA (60 mg, Solution for injection, SAR 1987.45).

Is Somatrogon approved by the US FDA?

Drugs@FDA lists 1 application product line for Somatrogon, including NGENLA (Prescription).

Is Somatrogon authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Somatrogon: Ngenla.

Are there safety signals or safety updates for Somatrogon?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2026-04-29).

Active substance

Somatrogon

SFDA 2
US FDA 1
EMA 1
Health Canada 2
NHS prices 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
NGENLA	24 mg	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 795.00	Biological · Prescription	Pfizer Europe MA EEIG	Valid
NGENLA	60 mg	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 1987.45	Biological · Prescription	Pfizer Europe MA EEIG	Valid

Indications — CHI Daman Drug Formulary

CHILD GROWTH HORMONE DEFICIENCY

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

Product	Strength	Form · route	Applicant	Status	First approved
NGENLA	24MG; 60MG	injectable · injection	PFIZER IRELAND PHARMACEUTICALS	Prescription	27 Jun 2023

EMA European Union — centrally authorised medicines

Ngenla Pfizer Europe MA EEIG · Authorised · authorised 14 Feb 2022 · ATC H01AC08

Therapeutic indication (EMA)

Indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
NGENLA	02521679	20 MG / ML	SOLUTION · SUBCUTANEOUS	PFIZER CANADA ULC
NGENLA	02521687	50 MG / ML	SOLUTION · SUBCUTANEOUS	PFIZER CANADA ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Somatrogon 60mg/1.2ml solution for injection pre-filled disposable devices	£415.20	1 pre-filled disposable injection	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 29 Apr 2026 NGENLA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 4 Sep 2025 PRAC signal: Lipoatrophy
Action for MAH: update of the product information: Yes
EMA PRAC 8 May 2025 PRAC signal: Lipoatrophy
Action for MAH: update of the product information: No

All safety entries for somatrogon →

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.