Is Interferon beta 1a registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Interferon beta 1a, including AVONEX 30 mcg/0.5 ml pre-filled pen (30 µg, Solution for injection, SAR 3329.40); REBIF 22 MCG PRE-FILLED SYRINGE (22 µg, Solution for injection, SAR 1984.10); REBIF 22 MCG/0.5 ml Solution for injection in cartridge (66 µg, Solution for injection, SAR 1979.15); REBIF 44 MCG PRE-FILLED SYRINGE (44 µg, Solution for injection, SAR 3756.75); REBIF 44 MCG/0.5 ml Solution for injection in cartridge (132 µg, Solution for injection, SAR 3958.25).

Is Interferon beta 1a approved by the US FDA?

Drugs@FDA lists 2 application product lines for Interferon beta 1a, including AVONEX (Prescription); REBIF (Prescription).

Is Interferon beta 1a authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Interferon beta 1a: Avonex, Rebif.

Are there safety signals or safety updates for Interferon beta 1a?

EMA PRAC: 3 entries; US FDA: 2 entries (latest 2023-07-28).

Active substance

Interferon beta 1a

SFDA 5
US FDA 2
EMA 3
Health Canada 5
US price lines 1
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AVONEX 30 mcg/0.5 ml pre-filled pen	30 µg	Solution for injection · Intramuscular use	4 Pre-filled pen	SAR 3329.40	Biological · Prescription	Biogen Idec B.V-Natherland	Valid
REBIF 22 MCG PRE-FILLED SYRINGE	22 µg	Solution for injection · Subcutaneous use	12 Pre-filled syringe	SAR 1984.10	Biological · Prescription	SERONO	Valid
REBIF 22 MCG/0.5 ml Solution for injection in cartridge	66 µg	Solution for injection · Subcutaneous use	4 Cartridge	SAR 1979.15	Biological · Prescription	MERCK SERONO EUROPE LTD	Valid
REBIF 44 MCG PRE-FILLED SYRINGE	44 µg	Solution for injection · Subcutaneous use	12 Pre-filled syringe	SAR 3756.75	Biological · Prescription	SERONO	Valid
REBIF 44 MCG/0.5 ml Solution for injection in cartridge	132 µg	Solution for injection · Subcutaneous use	4 Cartridge	SAR 3958.25	Biological · Prescription	MERCK SERONO EUROPE LTD	Valid

Indications — CHI Daman Drug Formulary

MULTIPLE SCLEROSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
AVONEX	30UG/ML	vial	BIOGEN	Prescription	17 May 1996
REBIF	22UG/0.5ML; 44UG/0.5ML	syringe	SERONO INC	Prescription	7 Mar 2002

EMA European Union — centrally authorised medicines

Avonex Biogen Netherlands B.V. · Authorised · authorised 13 Mar 1997 · ATC L03AB07

Therapeutic indication (EMA)

Avonex is indicated for the treatment of: patients diagnosed with relapsing multiple sclerosis (MS). In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three years without evidence of continuous progression between relapses; Avonex slows the progression of disability and decreases the frequency of relapses; patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite MS. Avonex should be discontinued in patients who develop progressive MS.

Rebif Merck Europe B.V. · Authorised · authorised 3 May 1998 · ATC L03AB07

Therapeutic indication (EMA)

Rebif is indicated for the treatment of: patients with a single demyelinating event with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis; patients with relapsing multiple sclerosis. In clinical trials, this was characterised by two or more acute exacerbations in the previous two years. Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity.

Biferonex BioPartners GmbH · Application withdrawn

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AVONEX	02269201	30 MCG / 0.5 ML	SOLUTION · INTRAMUSCULAR	BIOGEN CANADA INC
REBIF	02237319	22 MCG / 0.5 ML	SOLUTION · SUBCUTANEOUS	EMD SERONO, A DIVISION OF EMD INC., CANADA
REBIF	02237320	44 MCG / 0.5 ML	SOLUTION · SUBCUTANEOUS	EMD SERONO, A DIVISION OF EMD INC., CANADA
REBIF	02318253	66 MCG / 1.5 ML	SOLUTION · SUBCUTANEOUS	EMD SERONO, A DIVISION OF EMD INC., CANADA
REBIF	02318261	132 MCG / 1.5 ML	SOLUTION · SUBCUTANEOUS	EMD SERONO, A DIVISION OF EMD INC., CANADA

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	AVONEX 30 MCG/0.5 ML SYRINGE KIT (4 PACK)	$8776.25231	per EA	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.

Safety signals and safety-related labeling changes

US FDA 28 Jul 2023 AVONEX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Jul 2023 REBIF — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 10 Apr 2015 PRAC signal: Pulmonary arterial hypertension
Action for MAH: update of the product information: Yes
EMA PRAC 4 Dec 2014 PRAC signal: Pulmonary arterial hypertension
Action for MAH: update of the product information: No
EMA PRAC 11 Sep 2014 PRAC signal: Pulmonary arterial hypertension
Action for MAH: update of the product information: No

All safety entries for interferon beta 1a →

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.