Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Pegasys   
Auth. number : EU/1/02/221
INN : peginterferon alfa-2a
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: L03AB11 - Peginterferon alfa-2a
(See WHO ATC Index)
Indication: Chronic hepatitis B
Pegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAg-negative chronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of viral replication, increased ALT and histologically verified liver inflammation and/or fibrosis.
Chonic hepatitis C
Adult patients
Pegasys is indicated for the treatment of chronic hepatitis C (CHC) in adult patients who are positive for serum hepatitis C virus ribonucleic acid (HCV-RNA). This includes patients with compensated cirrhosis and/or co-infected with clinically stable HIV.
The optimal way to use Pegasys in patients with chronic hepatitis C is in combination with ribavirin. The combination of Pegasys and ribavirin is indicated in treatment-naïve patients and in adult patients who have failed previous treatment with interferon alpha (pegylated or non-pegylated) alone or in combination therapy with ribavirin.
Monotherapy is indicated mainly in case of intolerance or contraindication to ribavirin.
Paediatric patients 5 years of age and older:
Pegasys in combination with ribavirin is indicated for the treatment of chronic hepatitis C in treatment-naïve children and adolescents 5 years of age and older who are positive for serum HCV-RNA.
When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis
Marketing Authorisation Holder: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, 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 continues to be 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
24/06/2002 Centralised - Authorisation EMEA/H/C/395 (2002)2416 of 20/06/2002
16/01/2003 Centralised - Variation EMEA/H/C/395/I/2, 3 (2003)305 of 14/01/2003
02/05/2003 Centralised - Variation EMEA/H/C/395/II/5
25/07/2003 Centralised - Variation EMEA/H/C/395/II/1 (2003)2777 of 23/07/2003
16/01/2004 Centralised - Variation EMEA/H/C/395/II/6 (2004)89 of 14/01/2004
12/05/2004 Centralised - Variation EMEA/H/C/395/N/8
Updated with Decision(2004)4326 of 29/10/2004
22/07/2004 Centralised - Variation EMEA/H/C/395/IB/10
Updated with Decision(2004)4326 of 29/10/2004
05/11/2004 Centralised - Variation EMEA/H/C/395/II/7 (2004)4326 of 29/10/2004
12/01/2005 Centralised - Variation EMEA/H/C/395/IB/12
Updated with Decision(2005)469 of 23/02/2005
31/01/2005 Centralised - Variation EMEA/H/C/395/II/9 (2005)244 of 26/01/2005
11/02/2005 Other procedure EMEA/H/C/395/IA/13
25/02/2005 Centralised - Variation EMEA/H/C/395/IA/17
Updated with Decision(2005)4257 of 25/10/2005
25/02/2005 Centralised - Variation EMEA/H/C/395/II/11 (2005)469 of 23/02/2005
03/03/2005 Centralised - Variation EMEA/H/C/395/IB/16
27/04/2005 Centralised - Variation EMEA/H/C/395/II/14
30/06/2005 Centralised - Variation EMEA/H/C/395/II/15
25/10/2005 Centralised - Variation EMEA/H/C/395/IA/19
Updated with Decision(2006)232 of 26/01/2006
27/10/2005 Centralised - Variation EMEA/H/C/395/IA/17 (2005)4257 of 25/10/2005
30/01/2006 Centralised - Variation EMEA/H/C/395/II/18 (2006)232 of 26/01/2006
04/05/2006 Centralised - Variation EMEA/H/C/395/II/20
31/05/2006 Centralised - Variation EMEA/H/C/395/II/21 (2006)2189 of 29/05/2006
26/07/2006 Centralised - Variation EMEA/H/C/395/II/47 (2006)3389 of 20/07/2006
26/09/2006 Centralised - Variation EMEA/H/C/395/II/23
28/09/2006 Centralised - Variation EMEA/H/C/395/IA/28
Updated with Decision(2006)5728 of 22/11/2006
21/11/2006 Centralised - Variation EMEA/H/C/395/II/26
24/11/2006 Centralised - Variation EMEA/H/C/395/II/25 (2006)5728 of 22/11/2006
09/01/2007 Centralised - Variation EMEA/H/C/395/II/24 (2007)24 of 04/01/2007
05/03/2007 Centralised - Variation EMEA/H/C/395/II/27 (2007)760 of 01/03/2007
25/06/2007 Centralised - Variation EMEA/H/C/395/II/30 (2007)3134 of 21/06/2007
25/06/2007 Centralised - Renewal EMEA/H/C/395/R/29 (2007)3145 of 21/06/2007
21/11/2007 Centralised - Variation EMEA/H/C/395/II/31, 32 (2007)5657 of 19/11/2007
25/02/2008 Centralised - Variation EMEA/H/C/395/II/34
24/06/2008 Centralised - Variation EMEA/H/C/395/II/33, 35 (2008)3151 of 20/06/2008
04/11/2008 Centralised - Variation EMEA/H/C/395/II/37 (2008)6607 of 30/10/2008
02/12/2008 Centralised - Variation EMEA/H/C/395/II/36 (2008)7795 of 28/11/2008
15/04/2009 Centralised - Variation EMEA/H/C/395/II/38 (2009)2908 of 08/04/2009
11/06/2009 Centralised - Variation EMEA/H/C/395/II/39
11/06/2009 Centralised - Variation EMEA/H/C/395/II/40
25/08/2009 Centralised - Variation EMEA/H/C/395/II/41, 42 (2009)6636 of 21/08/2009
27/10/2009 Centralised - Variation EMEA/H/C/395/II/43 (2009)8400 of 23/10/2009
07/07/2010 Centralised - Variation EMEA/H/C/395/II/44, 45 (2010)4705 of 02/07/2010
06/12/2010 Centralised - Variation EMEA/H/C/395/IB/46/G
21/04/2011 Centralised - Variation EMEA/H/C/395/II/48 (2011)2850 of 18/04/2011
01/07/2011 Centralised - Variation EMEA/H/C/395/II/47/G, EMEA/H/C/395/II/50 (2011)4802 of 29/06/2011
10/08/2011 Centralised - Variation EMEA/H/C/395/IA/53
Updated with Decision(2011)9747 of 14/12/2011
09/09/2011 Centralised - Variation EMEA/H/C/395/IB/56
Updated with Decision(2011)9747 of 14/12/2011
19/12/2011 Centralised - Variation EMEA/H/C/395/II/55 (2011)9747 of 14/12/2011
13/03/2012 Centralised - Variation EMEA/H/C/395/N/63
Updated with Decision(2012)6960 of 28/09/2012
03/10/2012 Referral EMEA/H/C/395/A-20 (2012)6960 of 28/09/2012
15/03/2013 Centralised - Variation EMEA/H/C/395/X/59/G (2013)1641 of 13/03/2013
02/10/2013 Centralised - Variation EMEA/H/C/395/N/69
Updated with Decision(2014)2806 of 23/04/2014
24/10/2013 Centralised - Variation EMEA/H/C/395/II/70
Updated with Decision(2014)2806 of 23/04/2014
24/10/2013 Centralised - Variation EMEA/H/C/395/II/71
Updated with Decision(2014)2806 of 23/04/2014