Regulatory PathRegulatory requirements compared

Active substance

Ribavirin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
COPEGUS 200 MG FILM COATED TABLET200 mgFilm-coated tablet · Oral use168 BlisterSAR 0.00NCE · PrescriptionROCHE & CO LTDValid
RIBAVIN 200 MG CAPSULES200 mgCapsule · Oral use60 BlisterSAR 590.05Generic · PrescriptionTHE ARAB PHARMACEUTICAL MANUFACTURING PSC (SAHAB)Valid
RIAVIRIN200 mgCapsule · Oral use60 BlisterSAR 590.05Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
RIAVIRIN200 mgCapsule · Oral use30 BlisterSAR 330.40Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
VIRAZOLE 20MG-MLUPON RECONSTITUTON INHAL20 mg/mlSolution · Oral use3 VialSAR 1841.30NCE · PrescriptionI.C.N.PHARMACEUTICALSInvalid · Not Marketed
Indications — CHI Daman Drug Formulary

HEPATITIS C; RESPIRATORY SYNCYTIAL VIRUS

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

ProductStrengthForm · routeApplicantStatusFirst approved
RIBAVIRIN200MGcapsule · oralZYDUS PHARMS USAPrescription28 Oct 2005
RIBAVIRIN200MGtablet · oralZYDUS PHARMS USAPrescription5 Dec 2005
RIBAVIRIN200MGtablet · oralSANDOZPrescription3 Oct 2006
RIBAVIRIN200MGtablet · oralAUROBINDO PHARMAPrescription17 Sep 2009
RIBAVIRIN200MGcapsule · oralAUROBINDO PHARMAPrescription17 Sep 2009
VIRAZOLE6GM/VIALfor solution · inhalationBAUSCHDiscontinued31 Dec 1985
REBETOL200MG **Indicated for use and comarketed with Interferon ALFA-2B, Recombinant (INTRON A), as Rebetron Combination Therapy**; 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralMERCK SHARP DOHMEDiscontinued3 Jun 1998
COPEGUS200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralROCHEDiscontinued3 Dec 2002
REBETOL40MG/MLsolution · oralSCHERINGDiscontinued29 Jul 2003
RIBAVIRIN200MGcapsule · oralCHARTWELL RXDiscontinued6 Apr 2004
RIBASPHERE200MGcapsule · oralCHARTWELL RXDiscontinued6 Apr 2004
RIBAVIRIN200MGcapsule · oralTEVADiscontinued4 Oct 2004
RIBAVIRIN200MGtablet · oralHERITAGE PHARMA AVETDiscontinued5 Dec 2005
RIBAVIRIN400MG; 600MG; 500MGtablet · oralZYDUS PHARMS USADiscontinued5 Dec 2005
RIBAVIRIN200MG; 400MG; 600MGtablet · oralCHARTWELL RXDiscontinued5 Dec 2005
RIBAVIRIN200MG; 400MG; 500MG; 600MGtablet · oralBEXIMCO PHARMS USADiscontinued12 Aug 2014
RIBAVIRIN6GM/VIALfor solution · inhalationCHARTWELL RXDiscontinued6 Oct 2016

EMA European Union — centrally authorised medicines

Rebetol Merck Sharp and Dohme B.V · Withdrawn · authorised 6 May 1999 · ATC J05AP01

Therapeutic indication (EMA)

Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation.

Cotronak Schering-Plough Europe · Withdrawn · authorised 7 May 1999 · ATC J05AB04

Therapeutic indication (EMA)

Cotronak is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b. Cotronak monotherapy must not be used.There is no safety or efficacy information on the use of Cotronak with other forms of interferon (i.e., not alfa-2b).Please refer also to the peginterferon alfa-2b or interferon alfa-2b Summary of Product Characteristics (SPC) for prescribing information particular to that product.

Ribavirin Teva Teva B.V. · Withdrawn · authorised 31 Mar 2009 · ATC J05AB04

Therapeutic indication (EMA)

Ribavirin Teva is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. Ribavirin monotherapy must not be used. There is no safety or efficacy information on the use of Ribavirin with other forms of interferon (i.e. not alfa-2b). Naïve patients Adult patients Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid HCV-RNA. Paediatric patients (children 3 years of age and older and adolescents) Ribavirin Teva is indicated, in a combination regimen with interferon alfa­2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, 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 reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis. Previous treatment failure patients Adult patients Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.

Ribavirin Teva Pharma B.V. Teva B.V. · Withdrawn · authorised 1 Jul 2009 · ATC J05AP01

Therapeutic indication (EMA)

Ribavirin Teva Pharma B.V. is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1). Ribavirin Teva Pharma B.V. is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation (see sections 4.2, 4.4 and 5.1).

Ribavirin BioPartners BioPartners GmbH · Lapsed · authorised 6 Apr 2010 · ATC J05AB04

Therapeutic indication (EMA)

Ribavirin BioPartners is indicated for the treatment of chronic hepatitis-C-virus (HCV) infection in adults, children three years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. Ribavirin monotherapy must not be used. There is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b). Naïve patients Adult patients Ribavirin BioPartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid (HCV-RNA) (see section 4.4) Children three years of age and older and adolescents Ribavirin BioPartners is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children three years of age and older and adolescents, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA. When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4). Previous-treatment-failure patients Adult patients Ribavirin BioPartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alfa monotherapy but who have subsequently relapsed (see section 5.1).

Ribavirin Mylan (previously Ribavirin Three Rivers) Mylan S.A.S · Withdrawn · authorised 10 Jun 2010 · ATC J05AB04

Therapeutic indication (EMA)

Ribavirin Mylan is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents). Ribavirin monotherapy must not be used. There is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b). Please refer also to the interferon alfa-2b summary of product characteristics (SmPC) for prescribing information particular to that product. Naïve patients Adult patients Ribavirin Mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum hepatitis-C-virus (HCV) RNA. Children and adolescents Ribavirin Mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents three years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for serum HCV RNA. When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case-by-case basis (see section 4.4). Previously treatment-failure patients Adult patients Ribavirin Mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
VIRAZOLE021701406 G / VIALPOWDER FOR SOLUTION; AEROSOL · INHALATIONBAUSCH HEALTH, CANADA INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACRIBAVIRIN 200 MG TABLET$0.45069per EA23 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)

  • 6.4.4.2.3. Medicines for hepatitis C > Other antivirals for hepatitis C · core
    Chronic hepatitis C
    Parenteral > General injections > IV: 1000 mg per 10 mL phosphate buffer solution; 800 mg per 10 mL phosphate buffer solution | Oral > Solid: 200 mg; 400 mg; 600 mg

Safety signals and safety-related labeling changes

  • US FDA 16 Mar 2022 REBETOL — 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 16 Mar 2022 REBETOL — 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 ribavirin →

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.