Is Peginterferon alfa 2a registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Peginterferon alfa 2a, including PEGASYS 180 MCG-0.5ML PRE-FILLED SYRINGE (180 µg, Injection, SAR 1134.30).

Is Peginterferon alfa 2a approved by the US FDA?

Drugs@FDA lists 2 application product lines for Peginterferon alfa 2a, including PEGASYS (Prescription); PEGASYS (Prescription).

Is Peginterferon alfa 2a authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Peginterferon alfa 2a: Pegasys.

Are there safety signals or safety updates for Peginterferon alfa 2a?

EMA PRAC: 9 entries; US FDA: 1 entry (latest 2023-12-11).

Active substance

Peginterferon alfa 2a

SFDA 2
US FDA 2
EMA 1
Health Canada 1
Safety 10

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
PEGASYS 180 MCG-0.5ML PRE-FILLED SYRINGE	180 µg	Injection · Subcutaneous use	1 Pre-filled syringe	SAR 1134.30	Biological · Prescription	ROCHE	Valid
PEGASYS 135 MCG-0.5ML PRE-FILLED SYRINGE	135 µg	Injection · Subcutaneous use	1 Pre-filled syringe	SAR 850.70	Biological · Prescription	ROCHE	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

CHRONIC MYELOID LEUKAEMIA (CML); HEPATITIS B; MYELOFIBROSIS-SYMPTOMATIC, LOW-RISK; POLYCYTHEMIA VERA; RENAL CELL CARCINOMA (RCC)-CC-RCC & NON-CC RCC; T-CELL LYMPHOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
PEGASYS	180UG/VIAL	vial · subcutaneous	Pharmaand GmbH	Prescription	16 Oct 2002
PEGASYS	180U/5ML	syringe	Pharmaand GmbH	Prescription	16 Oct 2002

EMA European Union — centrally authorised medicines

Pegasys pharmaand GmbH · Authorised · authorised 20 Jun 2002 · ATC L03AB11

Therapeutic indication (EMA)

Polycythaemia veraPegasys is indicated as monotherapy in adults for the treatment of polycythaemia vera. Essential thrombocythaemiaPegasys is indicated as monotherapy in adults for the treatment of essential thrombocythaemia..Chronic hepatitis BAdult patientsPegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAg-negative chronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (ALT) and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1).Paediatric patients 3 years of age and olderPegasys is indicated for the treatment of HBeAg-positive CHB in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum ALT levels. With respect to the decision to initiate treatment in paediatric patients see sections 4.2, 4.4 and 5.1.Chronic hepatitis CAdult patientsPegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis C (CHC) in patients with compensated liver disease (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.2 and 5.1.Paediatric patients 5 years of age and olderPegasys in combination with ribavirin is indicated for the treatment of CHC in treatment-naïve children and adolescents 5 years of age and older who are positive for serum HCV-RNA.When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PEGASYS	02248077	180 MCG / 0.5 ML	SOLUTION · SUBCUTANEOUS	PHARMAAND GMBH

Safety signals and safety-related labeling changes

US FDA 11 Dec 2023 PEGASYS — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 3 Sep 2020 PRAC signal: Neuromyelitis optica spectrum disorder
Action for MAH: update of the product information: Yes
EMA PRAC 12 Mar 2020 PRAC signal: Neuromyelitis optica spectrum disorder
Action for MAH: update of the product information: No
EMA PRAC 11 Feb 2016 PRAC signal: Acquired haemophilia
Action for MAH: update of the product information: No
EMA PRAC 14 Jan 2016 PRAC signal: Guillain-Barré syndrome (GBS)
Action for MAH: update of the product information: No
EMA PRAC 8 Oct 2015 PRAC signal: Acquired haemophilia
Action for MAH: update of the product information: No
EMA PRAC 10 Sep 2015 PRAC signal: Guillain-Barré syndrome (GBS)
Action for MAH: update of the product information: No
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 peginterferon alfa 2a →

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.