Is Glatiramer 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 Glatiramer, including GLATIJECT (20 mg/ml, Solution for injection, SAR 4110.40); GLATIJECT (40 mg/ml, Solution for injection, SAR 4293.55); Galtipex (40 mg/ml, Solution for injection, SAR 3864.20).

Is Glatiramer approved by the US FDA?

Drugs@FDA lists 12 application product lines for Glatiramer, including COPAXONE (Prescription); GLATOPA (Prescription); GLATIRAMER ACETATE (Prescription); GLATIRAMER ACETATE (Prescription); GLATOPA (Prescription).

Is Glatiramer on the WHO Model List of Essential Medicines?

Yes — 5.1.2. Medicines for multiple sclerosis (complementary list): Multiple sclerosis.

Are there safety signals or safety updates for Glatiramer?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2026-06-22).

Active substance

Glatiramer

SFDA 4
US FDA 12
Health Canada 4
US price lines 6
WHO EML 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
GLATIJECT	20 mg/ml	Solution for injection · Subcutaneous use	30 Pre-filled syringe	SAR 4110.40	Generic · Prescription	SPIMACO ADDWAEIH	Valid
GLATIJECT	40 mg/ml	Solution for injection · Subcutaneous use	12 Pre-filled syringe	SAR 4293.55	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Galtipex	40 mg/ml	Solution for injection · Subcutaneous use	12 Pre-filled syringe	SAR 3864.20	NCE · Prescription	Aspen Healthcare	Valid
Galtipex	20 mg/ml	Solution for injection · Subcutaneous use	28 Pre-filled syringe	SAR 3452.75	NCE · Prescription	Aspen Healthcare	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

MULTIPLE SCLEROSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
COPAXONE	20MG/ML; 40MG/ML	injectable · subcutaneous	TEVA PHARMS USA	Prescription	20 Dec 1996
GLATOPA	20MG/ML	injectable · subcutaneous	SANDOZ	Prescription	16 Apr 2015
GLATIRAMER ACETATE	20MG/ML	injectable · subcutaneous	MYLAN	Prescription	3 Oct 2017
GLATIRAMER ACETATE	40MG/ML	injectable · subcutaneous	MYLAN	Prescription	3 Oct 2017
GLATOPA	40MG/ML	injectable · subcutaneous	SANDOZ	Prescription	12 Feb 2018
GLATIRAMER ACETATE	20MG/ML	injectable · subcutaneous	SYNTHON BV	Prescription	25 Sep 2024
GLATIRAMER ACETATE	40MG/ML	injectable · subcutaneous	SYNTHON BV	Prescription	25 Sep 2024
GLATIRAMER ACETATE	20MG/ML; 40MG/ML	injectable · subcutaneous	CHEMI SPA	Prescription	7 May 2025
GLATIRAMER ACETATE	20MG/ML; 40MG/ML	injectable · subcutaneous	SCINOPHARM TAIWAN	Prescription	31 Dec 2025
GLATIRAMER ACETATE	20MG/ML	injectable · subcutaneous	HYBIO	Prescription	11 Feb 2026
GLATIRAMER ACETATE	40MG/ML	injectable · subcutaneous	HYBIO	Prescription	11 Feb 2026
COPAXONE	20MG/VIAL	for solution · subcutaneous	TEVA PHARMS USA	Discontinued	20 Dec 1996

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
COPAXONE	02245619	20 MG / ML	SOLUTION · SUBCUTANEOUS	TEVA CANADA LIMITED
COPAXONE	02456915	40 MG / ML	SOLUTION · SUBCUTANEOUS	TEVA CANADA LIMITED
GLATECT	02460661	20 MG / ML	SOLUTION · SUBCUTANEOUS	PHARMASCIENCE INC
GLATIRAMER ACETATE INJECTION	02541440	20 MG / ML	SOLUTION · SUBCUTANEOUS	MYLAN PHARMACEUTICALS ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	COPAXONE 20 MG/ML SYRINGE	$229.7988	per ML	23 Sep 2026
US NADAC	COPAXONE 40 MG/ML SYRINGE	$541.11563	per ML	23 Sep 2026
US NADAC	GLATIRAMER 20 MG/ML SYRINGE	$41.75705	per ML	23 Sep 2026
US NADAC	GLATIRAMER 40 MG/ML SYRINGE	$86.09516	per ML	23 Sep 2026
US NADAC	GLATOPA 20 MG/ML SYRINGE	$41.75705	per ML	23 Sep 2026
US NADAC	GLATOPA 40 MG/ML SYRINGE	$86.09516	per ML	23 Sep 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.

WHO WHO Model List of Essential Medicines (2025)

5.1.2. Medicines for multiple sclerosis · complementary
Multiple sclerosis
Parenteral > General injections > SC: 20 mg per mL in pre-filled syringe; 40 mg per mL in pre-filled syringe

Safety signals and safety-related labeling changes

US FDA 22 Jun 2026 COPAXONE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 30 Nov 2023 PRAC signal: Anaphylaxis with a long latency
Action for MAH: update of the product information: No

All safety entries for glatiramer →

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.