PegIntron
Withdrawn
This medicine's authorisation has been withdrawn
peginterferon alfa-2b
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 21 April 2021, the European Commission withdrew the marketing authorisation for PegIntron (peginterferon alfa-2b) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Merck Sharp & Dohme B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
PegIntron was granted marketing authorisation in the EU on 25 May 2000 for the treatment of chronic hepatitis C. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2005. It was then granted unlimited validity in 2010.
The European Public Assessment Report (EPAR) for PegIntron is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
T/0135
21/04/2021
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- PegIntron
- Active substance
- peginterferon alfa-2b
- International non-proprietary name (INN) or common name
- peginterferon alfa-2b
- Therapeutic area (MeSH)
- Hepatitis C, Chronic
- Anatomical therapeutic chemical (ATC) code
- L03AB10
Pharmacotherapeutic group
ImmunostimulantsTherapeutic indication
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.
News on PegIntron
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