Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: PegIntron   
Auth. number : EU/1/00/131
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: Adult patients:PegIntron is indicated for the treatment of adult patients with chronic hepatitis C 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).The best way to use PegIntron in this indication is in combination with ribavirin.This combination is indicated in naïve patients including patients with clinically stable HIV coinfection and in 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 PegIntron, is indicated mainly in case of intolerance or contraindication to ribavirin.Paediatric patients 3 years of age and older:PegIntron 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).Please refer also to the ribavirin Summary of Product Characteristics (SPC) for capsules or oral solution when PegIntron 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/280 (2000)1407 of 25/05/2000
14/09/2000 Centralised - Variation EMEA/H/C/280/II/2
07/11/2000 Centralised - Variation EMEA/H/C/280/I/3
17/11/2000 Centralised - Variation EMEA/H/C/280/I/4, 5 (2000)3227 of 16/11/2000
18/01/2001 Centralised - Variation EMEA/H/C/280/I/8, 9
18/01/2001 Centralised - Variation EMEA/H/C/280/I/12
18/01/2001 Centralised - Variation EMEA/H/C/280/I/6, 7, 10, 11
02/04/2001 Centralised - Variation EMEA/H/C/280/II/1 (2001)794 of 26/03/2001
16/07/2001 Centralised - Variation EMEA/H/C/280/I/16
15/10/2001 Centralised - Variation EMEA/H/C/280/II/13
08/02/2002 Centralised - Variation EMEA/H/C/280/X/14 (2002)494 of 06/02/2002
04/03/2002 Centralised - Variation EMEA/H/C/280/I/17
08/04/2002 Centralised - Variation EMEA/H/C/280/I/18
13/05/2002 Centralised - Variation EMEA/H/C/280/II/15 (2002)1880 of 07/05/2002
24/06/2002 Centralised - Variation EMEA/H/C/280/II/20
24/06/2002 Centralised - Variation EMEA/H/C/280/I/21
24/06/2002 Centralised - Variation EMEA/H/C/280/II/19
15/07/2002 Centralised - Variation EMEA/H/C/280/I/22 (2002)2857 of 19/07/2002
15/07/2002 Centralised - Variation EMEA/H/C/280/N/24 (2002)2725 of 11/07/2002
17/07/2002 Centralised - Variation EMEA/H/C/280/N/25 (2002)2791 of 15/07/2002
30/07/2002 Centralised - Variation EMEA/H/C/280/II/23
24/09/2002 Centralised - Variation EMEA/H/C/280/I/29
27/09/2002 Centralised - Variation EMEA/H/C/280/I/26
08/10/2002 Centralised - Variation EMEA/H/C/280/I/27
28/11/2002 Centralised - Variation EMEA/H/C/280/N/30 (2002)4794 of 26/11/2002
13/12/2002 Centralised - Variation EMEA/H/C/280/I/31
19/03/2003 Centralised - Variation EMEA/H/C/280/II/28 (2003)851 of 17/03/2003
02/04/2003 Centralised - Variation EMEA/H/C/280/II/32
16/05/2003 Centralised - Variation EMEA/H/C/280/N/33 (2003)1656 of 14/05/2003
14/07/2003 Centralised - Variation EMEA/H/C/280/I/34
30/09/2003 Centralised - Variation EMEA/H/C/280/II/37
06/10/2003 Centralised - Variation EMEA/H/C/280/II/35 (2003)3578 of 02/10/2003
28/10/2003 Centralised - Variation EMEA/H/C/280/II/36 (2003)4006 of 24/10/2003
13/11/2003 Centralised - Variation EMEA/H/C/280/I/40
15/12/2003 Centralised - Variation EMEA/H/C/280/IB/39
Updated with Decision(2004)906 of 16/03/2004
09/02/2004 Centralised - Variation EMEA/H/C/280/II/38 (2004)412 of 05/02/2004
10/02/2004 Centralised - Variation EMEA/H/C/280/II/43
05/03/2004 Centralised - Variation EMEA/H/C/280/II/41
18/03/2004 Centralised - Variation EMEA/H/C/280/II/44 (2004)906 of 16/03/2004
02/08/2004 Centralised - Variation EMEA/H/C/280/II/47
25/08/2004 Centralised - Variation EMEA/H/C/280/II/45 (2004)3333 of 23/08/2004
22/09/2004 Centralised - Variation EMEA/H/C/280/II/42
22/10/2004 Centralised - Variation EMEA/H/C/280/II/48 (2004)4201 of 20/10/2004
24/01/2005 Centralised - Variation EMEA/H/C/280/IA/52
21/02/2005 Centralised - Variation EMEA/H/C/280/II/49
24/03/2005 Centralised - Variation EMEA/H/C/280/II/50 (2005)1015 of 22/03/2005
27/05/2005 Centralised - Renewal EMEA/H/C/280/R/51 (2005)1613 of 25/05/2005
01/09/2005 Centralised - Variation EMEA/H/C/280/IA/58
06/09/2005 Centralised - Variation EMEA/H/C/280/IB/57
13/09/2005 Centralised - Variation EMEA/H/C/280/II/54 (2005)3495 of 08/09/2005
23/09/2005 Centralised - Variation EMEA/H/C/280/II/55
18/11/2005 Centralised - Variation EMEA/H/C/280/II/53, 56 (2005)4485 of 15/11/2005
27/03/2006 Centralised - Variation EMEA/H/C/280/II/60
02/05/2006 Centralised - Variation EMEA/H/C/280/II/59 (2006)1826 of 27/04/2006
23/05/2006 Centralised - Variation EMEA/H/C/280/II/61 (2006)2123 of 19/05/2006
24/05/2006 Centralised - Variation EMEA/H/C/280/II/62
25/07/2006 Centralised - Variation EMEA/H/C/280/II/63 (2006)3358 of 19/07/2006
08/09/2006 Centralised - Variation EMEA/H/C/280/II/64 (2006)4070 of 01/09/2006
25/10/2006 Centralised - Variation EMEA/H/C/280/II/66, 67 (2006)5150 of 23/10/2006
10/01/2007 Centralised - Variation EMEA/H/C/280/N/71
Updated with Decision(2007)2602 of 13/06/2007
01/03/2007 Centralised - Variation EMEA/H/C/280/II/69
01/03/2007 Centralised - Variation EMEA/H/C/280/II/70
15/06/2007 Centralised - Variation EMEA/H/C/280/II/68 (2007)2602 of 13/06/2007
21/08/2007 Centralised - Variation EMEA/H/C/280/IB/75
27/09/2007 Centralised - Variation EMEA/H/C/280/II/73
05/11/2007 Centralised - Variation EMEA/H/C/280/II/69, 72, 74 (2007)5387 of 30/10/2007
30/01/2008 Centralised - Variation EMEA/H/C/280/II/76 (2008)415 of 28/01/2008
16/04/2008 Centralised - Variation EMEA/H/C/280/II/78, 79 (2008)1522 of 14/04/2008
22/05/2008 Centralised - Variation EMEA/H/C/280/IA/81
Updated with Decision(2008)3663 of 10/07/2008
11/06/2008 Centralised - Variation EMEA/H/C/280/II/77
14/07/2008 Centralised - Variation EMEA/H/C/280/II/80 (2008)3663 of 10/07/2008
23/07/2008 Centralised - Variation EMEA/H/C/280/IA/84
04/11/2008 Centralised - Variation EMEA/H/C/280/II/83 (2008)6664 of 31/10/2008
28/11/2008 Centralised - Variation EMEA/H/C/280/II/86
09/12/2008 Centralised - Variation EMEA/H/C/280/II/82 (2008)8246 of 05/12/2008
05/01/2009 Centralised - Variation EMEA/H/C/280/II/88
06/05/2009 Centralised - Variation EMEA/H/C/280/II/89
05/08/2009 Centralised - Variation EMEA/H/C/280/II/90 (2009)6249 of 03/08/2009
13/11/2009 Centralised - Variation EMEA/H/C/280/II/85, 87, EMEA/H/C/II/280/87 (2009)9015 of 11/11/2009
16/11/2009 Centralised - Variation EMEA/H/C/280/IA/92
08/12/2009 Centralised - Variation EMEA/H/C/280/II/91
07/05/2010 Centralised - Renewal EMEA/H/C/280/R/93 (2010)3077 of 05/05/2010
29/06/2010 Centralised - Variation EMEA/H/C/280/II/94
04/11/2010 Centralised - Variation EMEA/H/C/280/II/95 (2010)7629 of 28/10/2010
04/02/2011 Centralised - Variation EMEA/H/C/280/IG/37
18/02/2011 Centralised - Variation EMEA/H/C/280/WS/90
03/03/2011 Centralised - Variation EMEA/H/C/280/WS/79 (2011)1489 of 28/02/2011
17/06/2011 Centralised - Variation EMEA/H/C/280/WS/80 (2011)4347 of 15/06/2011
01/07/2011 Centralised - Variation EMEA/H/C/280/WS/110 (2011)4814 of 29/06/2011
27/07/2011 Centralised - Variation EMEA/H/C/280/N/96
Updated with Decision(2011)6127 of 24/08/2011
26/08/2011 Centralised - Variation EMEA/H/C/280/WS/124 (2011)6127 of 24/08/2011
18/01/2012 Centralised - Variation EMEA/H/C/280/IG/140
Updated with Decision(2012)1925 of 19/03/2012
21/03/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/280/T/106 (2012)1925 of 19/03/2012
28/03/2012 Centralised - Variation EMEA/H/C/280/WS/216 (2012)2176 of 26/03/2012
03/06/2013 Centralised - Variation EMEA/H/C/280/WS/303/G (2013)3381 of 30/05/2013
25/10/2013 Centralised - Variation EMEA/H/C/280/N/114
Updated with Decision(2014)3559 of 22/05/2014
21/11/2013 Centralised - Variation EMEA/H/C/280/WS/429
Updated with Decision(2014)3559 of 22/05/2014
21/11/2013 Centralised - Variation EMEA/H/C/280/WS/414
Updated with Decision(2014)3559 of 22/05/2014
03/06/2014 Centralised - Modification EMEA/H/C/280/PSUV/117 (2014)3559 of 22/05/2014