Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: ViraferonPeg   
Auth. number : EU/1/00/132
INN : Peginterferon 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: L03AB10 - Peginterferon alfa-2b
(See WHO ATC Index)
Indication: Adults (tritherapy):
ViraferonPeg 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 (see section 5.1).
Please refer to the ribavirin and boceprevir Summary of Product Characteristics (SmPCs) when ViraferonPeg is to be used in combination with these medicines.

Adults (bitherapy and monotherapy):
ViraferonPeg 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 (see section 4.4).
ViraferonPeg 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 nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy (see section 5.1).
Interferon monotherapy, including ViraferonPeg, is indicated mainly in case of intolerance or contraindication to ribavirin.
Please refer to the ribavirin SmPC when ViraferonPeg is to be used in combination with ribavirin.

Paediatric population (bitherapy):
ViraferonPeg 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, 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. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4).
Please refer to the ribavirin SmPC for capsules or oral solution when ViraferonPeg is to be used in combination with ribavirin.
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
05/06/2000 Centralised - Authorisation EMEA/H/C/329 (2000)1447 of 29/05/2000
14/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/2
28/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/I/3
17/11/2000 Centralised - Variation EMEA/H/C/329/I/4, 5 (2000)3247 of 16/11/2000
19/01/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/I/12
19/01/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/I/6, 7, 10, 11
02/04/2001 Centralised - Variation EMEA/H/C/329/II/1 (2001)792 of 26/03/2001
16/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/I/16
15/09/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/I/8, 9
15/10/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/13
08/02/2002 Centralised - Variation EMEA/H/C/329/X/14 (2002)493 of 06/02/2002
04/03/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/I/17
08/04/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/I/18
13/05/2002 Centralised - Variation EMEA/H/C/329/II/15 (2002)1881 of 07/05/2002
24/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/I/21
26/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/19
26/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/20
15/07/2002 Centralised - Notification EMEA/H/C/329/N/24 (2002)2726 of 11/07/2002
18/07/2002 Centralised - Notification EMEA/H/C/329/N/25 (2002)2808 of 16/07/2002
23/07/2002 Centralised - Variation EMEA/H/C/329/I/22 (2002)2859 of 19/07/2002
30/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/23
24/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/I/29
27/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/I/26
08/10/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/I/27
28/11/2002 Centralised - Notification EMEA/H/C/329/N/30 (2002)4793 of 26/11/2002
13/12/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/I/31
19/03/2003 Centralised - Variation EMEA/H/C/329/II/28 (2003)849 of 17/03/2003
02/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/32
16/05/2003 Centralised - Notification EMEA/H/C/329/N/33 (2003)1650 of 14/05/2003
14/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/I/34
30/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/37
06/10/2003 Centralised - Variation EMEA/H/C/329/II/35 (2003)3577 of 02/10/2003
28/10/2003 Centralised - Variation EMEA/H/C/329/II/36 (2003)4020 of 24/10/2003
13/11/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/I/40
15/12/2003 Centralised - Variation EMEA/H/C/329/IB/39
Updated with Decision(2004)905 of 16/03/2004
09/02/2004 Centralised - Variation EMEA/H/C/329/II/38 (2004)404 of 05/02/2004
10/02/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/43
05/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/41
18/03/2004 Centralised - Variation EMEA/H/C/329/II/44 (2004)905 of 16/03/2004
02/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/46
25/08/2004 Centralised - Variation EMEA/H/C/329/II/45 (2004)3329 of 23/08/2004
22/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/42
22/10/2004 Centralised - Variation EMEA/H/C/329/II/47 (2004)4194 of 20/10/2004
24/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/IA/51
21/02/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/48
24/03/2005 Centralised - Variation EMEA/H/C/329/II/49 (2005)1016 of 22/03/2005
27/05/2005 Centralised - Renewal EMEA/H/C/329/R/50 (2005)1614 of 25/05/2005
01/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/IA/57
06/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/IB/56
13/09/2005 Centralised - Variation EMEA/H/C/329/II/53 (2005)3496 of 08/09/2005
23/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/54
21/11/2005 Centralised - Variation EMEA/H/C/329/II/52, 55 (2005)4497 of 15/11/2005
27/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/59
02/05/2006 Centralised - Variation EMEA/H/C/329/II/58 (2006)1828 of 27/04/2006
23/05/2006 Centralised - Variation EMEA/H/C/329/II/60 (2006)2126 of 19/05/2006
24/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/IB/61
25/07/2006 Centralised - Variation EMEA/H/C/329/II/62 (2006)3361 of 19/07/2006
07/09/2006 Centralised - Variation EMEA/H/C/329/II/51 (2006)4067 of 01/09/2006
24/10/2006 Centralised - Variation EMEA/H/C/329/II/65, 66 (2006)5119 of 20/10/2006
10/01/2007 Centralised - Notification EMEA/H/C/329/N/70
Updated with Decision(2007)2596 of 13/06/2007
28/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/69
15/06/2007 Centralised - Variation EMEA/H/C/329/II/67 (2007)2596 of 13/06/2007
21/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/IB/74
27/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/72
05/11/2007 Centralised - Variation EMEA/H/C/329/II/68, 71, 73 (2007)5388 of 30/10/2007
30/01/2008 Centralised - Variation EMEA/H/C/329/II/75 (2008)414 of 28/01/2008
16/04/2008 Centralised - Variation EMEA/H/C/329/II/77, 78 (2008)1521 of 14/04/2008
22/05/2008 Centralised - Variation EMEA/H/C/329/IA/80
Updated with Decision(2008)3659 of 10/07/2008
11/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/76
14/07/2008 Centralised - Variation EMEA/H/C/329/II/79 (2008)3659 of 10/07/2008
23/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/IA/83
04/11/2008 Centralised - Variation EMEA/H/C/329/II/82 (2008)6663 of 31/10/2008
28/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/85
09/12/2008 Centralised - Variation EMEA/H/C/329/II/81 (2008)8247 of 05/12/2008
05/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/87
27/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/88
30/07/2009 Centralised - Variation EMEA/H/C/329/II/89 (2009)6115 of 27/07/2009
03/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/IA/91
17/11/2009 Centralised - Variation EMEA/H/C/329/II/84, 86 (2009)9054 of 12/11/2009
08/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/90
07/05/2010 Centralised - Renewal EMEA/H/C/329/R/92 (2010)3069 of 05/05/2010
29/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/II/93
04/11/2010 Centralised - Variation EMEA/H/C/329/II/94 (2010)7631 of 28/10/2010
04/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/IG/37
07/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/329/WS/90
10/06/2011 Centralised - Notification EMEA/H/C/329/N/95
Updated with Decision(2011)6161 of 24/08/2011
24/06/2011 Centralised - Variation EMEA/H/C/329/WS/79, 80 (2011)4396 of 16/06/2011
18/07/2011 Centralised - Variation EMEA/H/C/329/WS/110 (2011)5202 of 13/07/2011
30/08/2011 Centralised - Variation EMEA/H/C/329/WS/124 (2011)6161 of 24/08/2011
18/01/2012 Centralised - Variation EMEA/H/C/329/IG/140
Updated with Decision(2012)2175 of 26/03/2012
28/03/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/329/T/99 (2012)2175 of 26/03/2012
03/04/2012 Centralised - Variation EMEA/H/C/329/WS/216 (2012)2325 of 30/03/2012
03/06/2013 Centralised - Variation EMEA/H/C/329/WS/303/G (2013)3379 of 30/05/2013
25/10/2013 Centralised - Notification EMEA/H/C/329/N/107
Updated with Decision(2014)3560 of 22/05/2014
21/11/2013 Centralised - Variation EMEA/H/C/329/WS/414
Updated with Decision(2014)3560 of 22/05/2014
21/11/2013 Centralised - Variation EMEA/H/C/329/WS/429
Updated with Decision(2014)3560 of 22/05/2014
27/05/2014 Centralised - Modification EMEA/H/C/329/PSUV/110 (2014)3560 of 22/05/2014