Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: IntronA   
Auth. number : EU/1/99/127
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 lymphomaTreatment 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: Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

  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
13/03/2000 Centralised - Authorisation EMEA/H/C/281 (2000)574 of 09/03/2000
26/05/2000 Centralised - Variation EMEA/H/C/281/I/1 (2000)1283 of 24/05/2000
07/06/2000 Centralised - Variation EMEA/H/C/281/I/3
04/07/2000 Centralised - Variation EMEA/H/C/281/I/6
01/08/2000 Centralised - Variation EMEA/H/C/281/II/4
28/08/2000 Centralised - Variation EMEA/H/C/281/I/8
28/08/2000 Centralised - Variation EMEA/H/C/281/I/7
30/08/2000 Centralised - Variation EMEA/H/C/281/I/5 (2000)2404 of 21/08/2000
04/09/2000 Centralised - Variation EMEA/H/C/281/II/2 (2000)2544 of 28/08/2000
15/11/2000 Centralised - Variation EMEA/H/C/281/I/15
29/03/2001 Centralised - Variation EMEA/H/C/281/I/18
18/05/2001 Centralised - Variation EMEA/H/C/281/I/11
18/05/2001 Centralised - Variation EMEA/H/C/281/I/10
18/05/2001 Centralised - Variation EMEA/H/C/281/I/14
18/05/2001 Centralised - Variation EMEA/H/C/281/I/9
18/05/2001 Centralised - Variation EMEA/H/C/281/I/16
18/05/2001 Centralised - Variation EMEA/H/C/281/I/12
18/05/2001 Centralised - Variation EMEA/H/C/281/I/13
16/07/2001 Centralised - Variation EMEA/H/C/281/I/20
15/10/2001 Centralised - Variation EMEA/H/C/281/II/17
06/03/2002 Centralised - Variation EMEA/H/C/281/I/22
04/04/2002 Centralised - Variation EMEA/H/C/281/II/19 (2002)1382 of 02/04/2002
08/04/2002 Centralised - Variation EMEA/H/C/281/I/23
23/04/2002 Centralised - Variation EMEA/H/C/281/II/21 (2002)1565 of 19/04/2002
30/07/2002 Centralised - Variation EMEA/H/C/281/II/24
17/09/2002 Centralised - Variation EMEA/H/C/281/I/25
24/09/2002 Centralised - Variation EMEA/H/C/281/I/28
14/10/2002 Centralised - Variation EMEA/H/C/281/I/27 (2002)3922 of 10/10/2002
28/10/2002 Centralised - Variation EMEA/H/C/281/I/29
03/12/2002 Centralised - Variation EMEA/H/C/281/I/30
09/12/2002 Centralised - Variation EMEA/H/C/281/II/26 (2002)4991 of 05/12/2002
31/03/2003 Centralised - Variation EMEA/H/C/281/II/31
14/07/2003 Centralised - Variation EMEA/H/C/281/I/33
30/07/2003 Centralised - Variation EMEA/H/C/281/II/32 (2003)2821 of 28/07/2003
13/11/2003 Centralised - Variation EMEA/H/C/281/I/35
12/05/2004 Centralised - Variation EMEA/H/C/281/N/37
Updated with Decision(2004)3517 of 13/09/2004
02/08/2004 Centralised - Variation EMEA/H/C/281/II/38
15/09/2004 Centralised - Variation EMEA/H/C/281/II/39 (2004)3517 of 13/09/2004
02/11/2004 Centralised - Variation EMEA/H/C/281/II/36 (2004)4310 of 28/10/2004
09/12/2004 Centralised - Variation EMEA/H/C/281/IA/42
09/12/2004 Centralised - Variation EMEA/H/C/281/IA/43
28/01/2005 Centralised - Variation EMEA/H/C/281/II/34 (2005)202 of 25/01/2005
31/01/2005 Centralised - Variation EMEA/H/C/281/II/40
25/05/2005 Centralised - Renewal EMEA/H/C/281/R/41 (2005)1597 of 23/05/2005
01/09/2005 Centralised - Variation EMEA/H/C/281/IA/47
14/09/2005 Centralised - Variation EMEA/H/C/281/IB/46
23/09/2005 Centralised - Variation EMEA/H/C/281/II/44
02/11/2005 Centralised - Variation EMEA/H/C/281/II/45 (2005)4292 of 27/10/2005
24/11/2005 Centralised - Variation EMEA/H/C/281/IB/50
24/11/2005 Centralised - Variation EMEA/H/C/281/IB/49
28/02/2006 Centralised - Variation EMEA/H/C/281/II/48
31/03/2006 Centralised - Variation EMEA/H/C/281/II/51 (2006)1330 of 29/03/2006
02/05/2006 Centralised - Variation EMEA/H/C/281/II/52 (2006)1831 of 27/04/2006
23/05/2006 Centralised - Variation EMEA/H/C/281/II/53 (2006)2122 of 19/05/2006
25/07/2006 Centralised - Variation EMEA/H/C/281/II/54 (2006)3360 of 19/07/2006
08/09/2006 Centralised - Variation EMEA/H/C/281/II/55 (2006)4068 of 01/09/2006
10/01/2007 Centralised - Variation EMEA/H/C/281/II/57 (2007)71 of 08/01/2007
29/03/2007 Centralised - Variation EMEA/H/C/281/II/58
11/07/2007 Centralised - Variation EMEA/H/C/281/II/59 (2007)3402 of 09/07/2007
24/07/2007 Centralised - Variation EMEA/H/C/281/II/60
30/01/2008 Centralised - Variation EMEA/H/C/281/II/61 (2008)416 of 28/01/2008
26/02/2008 Centralised - Variation EMEA/H/C/281/II/62
17/03/2008 Centralised - Variation EMEA/H/C/281/IA/64
Updated with Decision(2008)1681 of 22/04/2008
24/04/2008 Centralised - Variation EMEA/H/C/281/II/63 (2008)1681 of 22/04/2008
02/12/2008 Centralised - Variation EMEA/H/C/281/II/67
05/01/2009 Centralised - Variation EMEA/H/C/281/II/68
13/01/2009 Centralised - Variation EMEA/H/C/281/II/66 (2009)86 of 09/01/2009
09/02/2009 Centralised - Variation EMEA/H/C/281/IB/71
Updated with Decision(2009)7834 of 07/10/2009
09/03/2009 Centralised - Variation EMEA/H/C/281/II/70
10/03/2009 Centralised - Variation EMEA/H/C/281/II/69 (2009)1709 of 06/03/2009
07/05/2009 Centralised - Variation EMEA/H/C/281/II/72
09/10/2009 Centralised - Variation (2009)7834 of 07/10/2009
17/11/2009 Centralised - Variation EMEA/H/C/281/II/65 (2009)9055 of 12/11/2009
23/11/2009 Centralised - Variation EMEA/H/C/281/II/75 (2009)9249 of 19/11/2009
08/12/2009 Centralised - Variation EMEA/H/C/281/II/74
03/03/2010 Centralised - Variation EMEA/H/C/281/II/76
17/03/2010 Centralised - Renewal EMEA/H/C/281/R/73 (2010)1759 of 15/03/2010
30/03/2010 Corrigendum (2010)2186 corr of 26/03/2010
30/03/2010 Centralised - Variation EMEA/H/C/281/II/77 (2010)2183 of 26/03/2010
28/06/2010 Centralised - Variation EMEA/H/C/281/IB/79
Updated with Decision(2011)135 of 11/01/2011
29/06/2010 Centralised - Variation EMEA/H/C/281/II/78
23/08/2010 Centralised - Variation EMEA/H/C/281/IB/80/G
Updated with Decision(2011)135 of 11/01/2011
14/12/2010 Centralised - Variation EMEA/H/C/281/N/81
Updated with Decision(2011)135 of 11/01/2011
18/01/2011 Centralised - Variation (2011)135 of 11/01/2011
07/03/2011 Centralised - Variation EMEA/H/C/281/WS/90
15/06/2011 Centralised - Variation EMEA/H/C/281/N/82
Updated with Decision(2011)6166 of 24/08/2011
22/06/2011 Centralised - Variation EMEA/H/C/281/WS/80 (2011)4403 of 16/06/2011
04/07/2011 Centralised - Variation EMEA/H/C/281/WS/10 (2011)4811 of 29/06/2011
30/08/2011 Centralised - Variation EMEA/H/C/281/WS/124 (2011)6166 of 24/08/2011
27/10/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/281/T/83 (2011)7793 of 24/10/2011
21/03/2013 Centralised - Variation EMEA/H/C/281/II/90
Updated with Decision(2014)1618 of 05/03/2014
01/07/2013 Centralised - Variation EMEA/H/C/281/N/92
Updated with Decision(2014)1618 of 05/03/2014
21/11/2013 Centralised - Variation EMEA/H/C/281/WS/429
Updated with Decision(2014)1618 of 05/03/2014
07/03/2014 Centralised - Variation (2014)1618 of 05/03/2014