Active substance
Peginterferon alfa 2b
- SFDA 10
- US FDA 3
- EMA 3
- Safety 7
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| PEG-INTRON 100MCG-0.5ML PRE-FILLED PEN | 100 µg | Powder and solvent for solution for injection · Subcutaneous use | 1 Pre-filled pen | SAR 877.50 | Biological · Prescription | SCHERING-PLOUGH | Withdrawn by MAH · Not Marketed |
| PEG-INTRON 100MCG\0.5ML VIAL | 100 µg | Powder and solvent for solution for injection · Subcutaneous use | 1 Vial | SAR 1005.05 | Biological · Prescription | SCHERING-PLOUGH | Withdrawn by MAH · Not Marketed |
| PEG-INTRON 120MCG-0.5ML PRE-FILLED PEN | 120 µg | Powder and solvent for solution for injection · Subcutaneous use | 1 Pre-filled pen | SAR 1138.00 | Biological · Prescription | SCHERING-PLOUGH | Withdrawn by MAH · Not Marketed |
| PEG-INTRON 120MCG\0.5ML VIAL | 120 µg | Powder and solvent for solution for injection · Subcutaneous use | 1 Vial | SAR 1206.00 | Biological · Prescription | SCHERING-PLOUGH | Withdrawn by MAH · Not Marketed |
| PEG-INTRON 150MCG-0.5ML PRE-FILLED PEN | 150 µg | Powder and solvent for solution for injection · Subcutaneous use | 1 Pre-filled pen | SAR 1422.50 | Biological · Prescription | SCHERING-PLOUGH | Withdrawn by MAH · Not Marketed |
| PEG-INTRON 150MCG\0.5ML VIAL | 150 µg | Powder and solvent for solution for injection · Subcutaneous use | 1 Vial | SAR 1507.55 | Biological · Prescription | SCHERING-PLOUGH | Withdrawn by MAH · Not Marketed |
| PEG-INTRON 50MCG-0.5ML PRE-FILLED PEN | 50 µg | Powder and solvent for solution for injection · Subcutaneous use | 1 Pre-filled pen | SAR 474.15 | Biological · Prescription | SCHERING-PLOUGH | Withdrawn by MAH · Not Marketed |
| PEG-INTRON 50MCG\0.5MLVIAL | 50 µg | Powder and solvent for solution for injection · Subcutaneous use | 1 Vial | SAR 502.55 | Biological · Prescription | SCHERING-PLOUGH | Withdrawn by MAH · Not Marketed |
| PEG-INTRON 80MCG-0.5ML PRE-FILLED PEN | 80 µg | Powder and solvent for solution for injection · Subcutaneous use | 1 Pre-filled pen | SAR 758.65 | Biological · Prescription | SCHERING-PLOUGH | Withdrawn by MAH · Not Marketed |
| PEG-INTRON 80MCG\0.5ML VIAL | 80 µg | Powder and solvent for solution for injection · Subcutaneous use | 1 Vial | SAR 804.05 | Biological · Prescription | SCHERING-PLOUGH | Withdrawn by MAH · Not Marketed |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PEGINTRON | 50UG/0.5ML; 80UG/0.5ML; 120UG/0.5ML; 150UG/0.5ML | vial | SCHERING | Prescription | 19 Jan 2001 |
| PEGINTRON | 50UG/0.5ML; 80UG/0.5ML; 150UG/0.5ML; 120UG/0.5ML | syringe | SCHERING | Prescription | 19 Jan 2001 |
| SYLATRON | 296 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL; 444 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL; 888 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL | vial | SCHERING | Prescription | 19 Jan 2001 |
EMA European Union — centrally authorised medicines
PegIntron Merck Sharp & Dohme B.V. · Withdrawn · authorised 24 May 2000 · ATC L03AB10
Therapeutic indication (EMA)
Adults (tritherapy) PegIntron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-C (CHC) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. Please refer to the ribavirin and boceprevir summaries of product characteristics (SmPCs) when PegIntron is to be used in combination with these medicines. Adults (bitherapy and monotherapy) PegIntron is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis-C-virus RNA (HCV-RNA), including patients with compensated cirrhosis and / or co-infected with clinically stable HIV. PegIntron in combination with ribavirin (bitherapy) is indicated for the treatment of CHC infection in adult patients who are previously untreated including patients with clinically stable HIV co-infection and in adult patients who have failed previous treatment with interferon-alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon-alpha monotherapy. Interferon monotherapy, including PegIntron, is indicated mainly in case of intolerance or contraindication to ribavirin. Please refer to the ribavirin SmPC when PegIntron is to be used in combination with ribavirin. Paediatric population (bitherapy) PegIntron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have CHC, previously untreated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The decision to treat should be made on a case-by-case basis. Please refer to the ribavirin SmPC for capsules or oral solution when PegIntron is to be used in combination with ribavirin.
ViraferonPeg Merck Sharp Dohme Ltd · Withdrawn · authorised 28 May 2000 · ATC L03AB10
Therapeutic indication (EMA)
Adults (tritherapy) ViraferonPeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-C (CHC) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. Please refer to the ribavirin and boceprevir summaries of product characteristics (SmPCs) when ViraferonPeg is to be used in combination with these medicines. Adults (bitherapy and monotherapy) ViraferonPeg is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis-C-virus RNA (HCV-RNA), including patients with compensated cirrhosis and / or co-infected with clinically stable HIV. ViraferonPeg in combination with ribavirin (bitherapy) is indicated for the treatment of CHC infection in adult patients who are previously untreated including patients with clinically stable HIV co-infection and in adult patients who have failed previous treatment with interferon alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon alpha monotherapy. Interferon monotherapy, including ViraferonPeg, is indicated mainly in case of intolerance or contraindication to ribavirin. Please refer to the ribavirin SmPC when ViraferonPeg is to be used in combination with ribavirin. Paediatric population (bitherapy) ViraferonPeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis C, previously untreated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The decision to treat should be made on a case-by-case basis. Please refer to the ribavirin SmPC for capsules or oral solution when ViraferonPeg is to be used in combination with ribavirin.
Safety signals and safety-related labeling changes
- 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 - US FDA 8 Jan 2019 PEGINTRON — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 21 Dec 2018 SYLATRON — safety-related labeling change
Labeling sections changed: 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
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.