Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Viraferon
Auth. number : EU/1/99/128
INN : Interferon alfa-2b
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L03 - Immunomodulating agents
Pharmacological subgroup: L03A - Immunostimulating agents
Chemical subgroup: L03AB - Interferons
Chemical substance: L03AB05 - Interferon alfa-2b
(See WHO ATC Index)
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
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 (HCVRNA) (see section 4.4).The best way to use IntronA in this indication is in combination with ribavirin.
Chidren 3 years of age and older and adolescents: IntronA is indicated, in a combination regimen with ribavirin, for the treatment of children 3 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. The reversibility of growth inhibition is uncertain The decision to treat should be made on a case by case basis (see section 4.4).

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 8 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 involvement.
Marketing Authorisation Holder: Schering-Plough Europe
Rue de Stalle, 73, 1180 Bruxelles, Belgique / Stallestraat, 73, 1180 Brussel/Bruxelles, Belgique/België

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
10/03/2000 Centralised - Authorisation EMEA/H/C/282 (2000)555 of 09/03/2000
22/05/2000 Centralised - Variation EMEA/H/C/282/I/1 (2000)1244 of 17/05/2000
07/06/2000 Centralised - Variation EMEA/H/C/282/I/3
05/07/2000 Centralised - Variation EMEA/H/C/282/I/5
01/08/2000 Centralised - Variation EMEA/H/C/282/II/4
28/08/2000 Centralised - Variation EMEA/H/C/282/I/6
28/08/2000 Centralised - Variation EMEA/H/C/282/I/7
04/09/2000 Centralised - Variation EMEA/H/C/282/II/2 (2000)2537 of 28/08/2000
18/05/2001 Centralised - Variation EMEA/H/C/282/I/10
18/05/2001 Centralised - Variation EMEA/H/C/282/I/12
18/05/2001 Centralised - Variation EMEA/H/C/282/I/11
18/05/2001 Centralised - Variation EMEA/H/C/282/I/14
18/05/2001 Centralised - Variation EMEA/H/C/282/I/9
18/05/2001 Centralised - Variation EMEA/H/C/282/I/8
18/05/2001 Centralised - Variation EMEA/H/C/282/I/16
18/05/2001 Centralised - Variation EMEA/H/C/282/I/13
16/07/2001 Centralised - Variation EMEA/H/C/282/I/18
15/10/2001 Centralised - Variation EMEA/H/C/282/II/15
06/03/2002 Centralised - Variation EMEA/H/C/282/I/20
04/04/2002 Centralised - Variation EMEA/H/C/282/II/17 (2002)1384 of 02/04/2002
08/04/2002 Centralised - Variation EMEA/H/C/282/I/21
23/04/2002 Centralised - Variation EMEA/H/C/282/II/19 (2002)1566 of 19/04/2002
30/07/2002 Centralised - Variation EMEA/H/C/282/II/22
17/09/2002 Centralised - Variation EMEA/H/C/282/I/23
24/09/2002 Centralised - Variation EMEA/H/C/282/I/26
14/10/2002 Centralised - Variation EMEA/H/C/282/I/25 (2002)3938 of 10/10/2002
28/10/2002 Centralised - Variation EMEA/H/C/282/I/27
09/12/2002 Centralised - Variation EMEA/H/C/282/II/24 (2002)5006 of 05/12/2002
31/03/2003 Centralised - Variation EMEA/H/C/282/II/29
14/07/2003 Centralised - Variation EMEA/H/C/282/I/31
31/07/2003 Centralised - Variation EMEA/H/C/282/II/30 (2003)2836 of 29/07/2003
13/11/2003 Centralised - Variation EMEA/H/C/282/I/33
02/08/2004 Centralised - Variation EMEA/H/C/282/II/35
15/09/2004 Centralised - Variation EMEA/H/C/282/II/36 (2004)3518 of 13/09/2004
01/11/2004 Centralised - Variation EMEA/H/C/282/II/34 (2004)4305 of 28/10/2004
09/12/2004 Centralised - Variation EMEA/H/C/282/IA/39
28/01/2005 Centralised - Variation EMEA/H/C/282/II/32 (2005)203 of 25/01/2005
31/01/2005 Centralised - Variation EMEA/H/C/282/II/37
25/05/2005 Centralised - Renewal EMEA/H/C/282/R/38 (2005)1599 of 23/05/2005
01/09/2005 Centralised - Variation EMEA/H/C/282/IA/43
14/09/2005 Centralised - Variation EMEA/H/C/282/IB/42
23/09/2005 Centralised - Variation EMEA/H/C/282/II/40
02/11/2005 Centralised - Variation EMEA/H/C/282/II/41 (2005)4297 of 27/10/2005
24/11/2005 Centralised - Variation EMEA/H/C/282/IB/46
24/11/2005 Centralised - Variation EMEA/H/C/282/IB/45
28/02/2006 Centralised - Variation EMEA/H/C/282/II/44
31/03/2006 Centralised - Variation EMEA/H/C/282/II/47 (2006)1333 of 29/03/2006
02/05/2006 Centralised - Variation EMEA/H/C/282/II/48 (2006)1830 of 27/04/2006
23/05/2006 Centralised - Variation EMEA/H/C/282/II/49 (2006)2124 of 19/05/2006
25/07/2006 Centralised - Variation EMEA/H/C/282/II/50 (2006)3359 of 19/07/2006
08/09/2006 Centralised - Variation EMEA/H/C/282/II/51 (2006)4069 of 01/09/2006
11/01/2007 Centralised - Variation EMEA/H/C/282/II/53 (2007)89 of 09/01/2007
29/03/2007 Centralised - Variation EMEA/H/C/282/II/54
24/07/2007 Centralised - Variation EMEA/H/C/282/II/56
30/01/2008 Centralised - Variation EMEA/H/C/282/II/57 (2008)417 of 28/01/2008
26/02/2008 Centralised - Variation EMEA/H/C/282/II/58
17/03/2008 Centralised - Variation EMEA/H/C/282/IA/60
Updated with Decision(2008)1682 of 22/04/2008
24/04/2008 Centralised - Variation EMEA/H/C/282/II/59 (2008)1682 of 22/04/2008
15/10/2008 Centralised - Withdrawal (2008)6054 of 13/10/2008