Is Pegvisomant 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 Pegvisomant, including Somavert (10 mg, Powder and solvent for solution for injection, SAR 7391.65); Somavert (15 mg, Powder and solvent for solution for injection, SAR 11087.45); Somavert (20 mg, Powder and solvent for solution for injection, SAR 14783.30).

Is Pegvisomant approved by the US FDA?

Drugs@FDA lists 1 application product line for Pegvisomant, including SOMAVERT (Prescription).

Is Pegvisomant authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Pegvisomant: Somavert.

Are there safety signals or safety updates for Pegvisomant?

US FDA: 1 entry (latest 2023-07-27).

Active substance

Pegvisomant

SFDA 3
US FDA 1
EMA 1
Health Canada 5
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
Somavert	10 mg	Powder and solvent for solution for injection · Subcutaneous use	30 Vial	SAR 7391.65	Biological · Prescription	Pfizer Europe MA EEIG	Valid
Somavert	15 mg	Powder and solvent for solution for injection · Subcutaneous use	30 Vial	SAR 11087.45	Biological · Prescription	Pfizer Europe MA EEIG	Valid
Somavert	20 mg	Powder and solvent for solution for injection · Subcutaneous use	30 Vial	SAR 14783.30	Biological · Prescription	Pfizer Europe MA EEIG	Valid

Indications — CHI Daman Drug Formulary

ACROMEGALY

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

Product	Strength	Form · route	Applicant	Status	First approved
SOMAVERT	10MG/VIAL; 15MG/VIAL; 20MG/VIAL; 25MG/VIAL; 30MG/VIAL	injectable · subcutaneous	PHARMACIA	Prescription	25 Mar 2003

EMA European Union — centrally authorised medicines

Somavert Pfizer Europe MA EEIG · Authorised · authorised 12 Nov 2002 · ATC H01AX01

Therapeutic indication (EMA)

Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF-I concentrations or was not tolerated. Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF -I concentrations or was not tolerated.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SOMAVERT	02272199	10 MG / VIAL	KIT; POWDER FOR SOLUTION · SUBCUTANEOUS	PFIZER CANADA ULC
SOMAVERT	02272202	15 MG / VIAL	KIT; POWDER FOR SOLUTION · SUBCUTANEOUS	PFIZER CANADA ULC
SOMAVERT	02272210	20 MG / VIAL	POWDER FOR SOLUTION; KIT · SUBCUTANEOUS	PFIZER CANADA ULC
SOMAVERT	02448831	25 MG / VIAL	KIT; POWDER FOR SOLUTION · SUBCUTANEOUS	PFIZER CANADA ULC
SOMAVERT	02448858	30 MG / VIAL	POWDER FOR SOLUTION; KIT · SUBCUTANEOUS	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

US FDA 27 Jul 2023 SOMAVERT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for pegvisomant →

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.