Pharmaceuticals - Community Register

  

List of nationally authorised medicinal products for human use

Roferon-A

Product name: Roferon-A
Also marketed in the EU under the name(s): Roceron-A, Roféron-A
Active substance: interferon alfa-2a
Indication: Treatment of:
1) Hairy cell leukemia.
2) AIDS patients with progressive, asymptomatic Kaposi's sarcoma who have a CD4 count > 250/mm3. AIDS patients with CD4 counts < 250/mm3, or those with a history of opportunistic infections or constitutional symptoms, are unlikely to respond to Roferon-A therapy and therefore should not be treated (see section 4.2 posology and method of administration).
3) Chronic phase Philadelphia-chromosome positive chronic myelogenous leukemia. Roferon-A is not an alternative treatment for CML patients who have an HLA-identical relative and for whom allogeneic bone marrow transplantation is planned or possible in the immediate future. It is still unknown whether Roferon-A can be considered as a treatment with a curative potential in this indication.
4) Cutaneous T-cell lymphoma. Interferon alfa-2a (Roferon-A) may be active in patients who have progressive disease and who are refractory to, or unsuitable for, conventional therapy.
5) Adult patients with histologically proven chronic hepatitis B who have markers for viral replication, i.e., those who are positive for HBV DNA or HBeAg.
6) Adult patients with histologically proven chronic hepatitis C who are positive for HCV antibodies and have elevated serum alanine aminotransferase (ALT) without liver decompensation. There is no evidence of long term benefit on clinical and histological grounds.
7) Follicular non-Hodgkin’s lymphoma.
8) Advanced renal cell carcinoma.
9) Patients with AJCC stage II malignant melanoma (Breslow tumour thickness > 1.5 mm, no lymph node involvement or cutaneous spread) who are free of disease after surgery.
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
18/06/1999 Referral EMEA/H/A-36/260 (1999)1628 of 16/06/1999