IntronA

Withdrawn

This medicine's authorisation has been withdrawn

interferon alfa-2b

Overview

The marketing authorisation for IntronA has been withdrawn at the request of the marketing-authorisation holder.

IntronA : EPAR - Summary for the public

Product information

IntronA : EPAR - Product Information

IntronA : EPAR - All Authorised presentations

Product details

• Name of medicine:
  IntronA
• Active substance:
  interferon alfa-2b
• International non-proprietary name (INN) or common name:
  interferon alfa-2b
• Therapeutic area (MeSH):
  • Carcinoid Tumor
  • Leukemia, Hairy Cell
  • Lymphoma, Follicular
  • Hepatitis B, Chronic
  • Hepatitis C, Chronic
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Melanoma
  • Multiple Myeloma
• Anatomical therapeutic chemical (ATC) code:
  L03AB05

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Chronic hepatitis B

Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis-B viral replication (presence of DNA of hepatitis-B virus (HBV-DNA) and hepatitis-B antigen (HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and / or fibrosis.

Chronic hepatitis C

Before initiating treatment with IntronA, consideration should be given to the results from clinical trials comparing IntronA with pegylated interferon.

Adult patients

IntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for hepatitis-C virus-RNA (HCV-RNA).

The best way to use IntronA in this indication is in combination with ribavirin.

Children three years of age and older and adolescents

IntronA 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, 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 resulted in reduced final adult height in some patients.

The decision to treat should be made on a case-by-case basis.

Hairy-cell leukaemia

Treatment of patients with hairy cell leukaemia.

Chronic myelogenous leukaemia

Monotherapy

Treatment of adult patients with Philadelphia-chromosome- or bcr/abl-translocation-positive chronic myelogenous leukaemia.

Clinical experience indicates that a haematological and cytogenetic major / minor response is obtainable in the majority of patients treated. A major cytogenetic response is defined by < 34 % Ph+ leukaemic cells in the bone marrow, whereas a minor response is ? 34 %, but < 90 % Ph+ cells in the marrow.

Combination therapy

The combination of interferon alfa-2b and cytarabine (Ara-C) administered during the first 12 months of treatment has been demonstrated to significantly increase the rate of major cytogenetic responses and to significantly prolong the overall survival at three years when compared to interferon alfa-2b monotherapy.

Multiple myeloma

As maintenance therapy in patients who have achieved objective remission (more than 50% reduction in myeloma protein) following initial induction chemotherapy.

Current clinical experience indicates that maintenance therapy with interferon alfa-2b prolongs the plateau phase; however, effects on overall survival have not been conclusively demonstrated.

Follicular lymphoma

Treatment of high-tumour-burden follicular lymphoma as adjunct to appropriate combination induction chemotherapy such as a CHOP-like regimen. High tumour burden is defined as having at least one of the following: bulky tumour mass (> 7 cm), involvement of three or more nodal sites (each > 3 cm), systemic symptoms (weight loss > 10 %, pyrexia > 38°C for more than eight days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia.

Carcinoid tumour

Treatment of carcinoid tumours with lymph node or liver metastases and with 'carcinoid syndrome'.

Malignant melanoma

As adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e.g. patients with primary or recurrent (clinical or pathological) lymph-node.

Authorisation details

• EMA product number:
  EMEA/H/C/000281
• Marketing authorisation holder:
  Merck Sharp & Dohme B.V.

  Waarderweg 39; 2031 BN Haarlem; The Netherlands

• Marketing authorisation issued:
  09/03/2000
• Revision:
  34

Assessment history

Changes since initial authorisation of medicine

IntronA : EPAR - Procedural steps taken and scientific information after authorisation

IntronA -H-C-PSUSA-00001758-201609: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/671966/2017

IntronA : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

IntronA : EPAR - Scientific Discussion

IntronA : EPAR - Procedural steps taken before authorisation