Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Rebetol   
Auth. number : EU/1/99/107
INN : ribavirin
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J05 - Antivirals for systemic use
Pharmacological subgroup: J05A - Agents affecting the virus directly
Chemical subgroup: J05AB - Nucleosides
Chemical substance: J05AB04 - Ribavirin
(See WHO ATC Index)
Indication: Rebetol 200 mg hard capsules
Rebetol is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age and older and adolescents and must only be used as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b. Rebetol monotherapy must not be used.
There is no safety or efficacy information on the use of Rebetol with other forms of interferon (i.e., not alfa-2b).
Naïve patients
Adult patients: Rebetol is indicated, in combination with interferon alfa-2b or peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid (HCV-RNA). In combination with peginterferon alfa-2b also patients with mpensated cirrhosis and/or clinically stable HIV co-infection are included (see section 4.4).
Children 3 years of age and older and adolescents: Rebetol is indicated, in a combination regimen with peginterferon alfa-2b or interferon alfa-2b, 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 to 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).
Previously treated patients
Adult patients: Rebetol is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alfa monotherapy but who have subsequently relapsed. Rebetol is indicated, in combination with peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have failed previous treatment with interferon alpha (pegylated or non-pegylated) alone or in combination with ribavirin (see section 5.1).

Rebetol 40 mg/ml oral solution
Rebetol is indicated, in a combination regimen with peginterferon alfa-2b or interferon alfa-2b, for the treatment of children 3 years of age and older and adolescents, who have chronic hepatitis C virus (HCV) infection, not previously treated, without liver decompensation, and who are positive for hepatitis C viral ribonucleic acid (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).
Rebetol monotherapy must not be used.
There is no safety or efficacy information in children or adolescents on the use of Rebetol with other forms of interferon (i.e., not alfa-2b).
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
17/05/1999 Centralised - Authorisation EMEA/H/C/246 (1999)1260 of 07/05/1999
26/07/2000 Centralised - Variation EMEA/H/C/246/II/3 (2000)2052 of 24/07/2000
28/03/2001 Centralised - Variation EMEA/H/C/246/II/5 (2001)791 of 26/03/2001
09/04/2001 Centralised - Variation EMEA/H/C/246/I/7
26/06/2001 Centralised - Variation EMEA/H/C/246/II/6
07/11/2001 Centralised - Variation EMEA/H/C/246/II/9
14/02/2002 Centralised - Variation EMEA/H/C/246/N/10 (2002)511 of 07/02/2002
16/04/2002 Centralised - Variation EMEA/H/C/246/II/8 (2002)1490 of 12/04/2002
15/04/2003 Centralised - Variation EMEA/H/C/246/I/12, 13
29/09/2003 Centralised - Variation EMEA/H/C/246/II/15
07/10/2003 Centralised - Variation EMEA/H/C/246/II/11 (2003)3614 of 03/10/2003
16/12/2003 Centralised - Variation EMEA/H/C/246/N/17 (2003)5024 of 12/12/2003
29/03/2004 Centralised - Variation EMEA/H/C/246/IB/20
02/07/2004 Centralised - Variation EMEA/H/C/246/N/21
Updated with Decision(2004)3483 of 09/09/2004
06/09/2004 Centralised - Renewal EMEA/H/C/246/R/19 (2004)3420 of 02/09/2004
13/09/2004 Centralised - Variation EMEA/H/C/246/II/18 (2004)3483 of 09/09/2004
25/11/2004 Centralised - Variation EMEA/H/C/246/II/22
27/01/2005 Centralised - Variation EMEA/H/C/246/X/16 (2005)211 of 25/01/2005
27/01/2005 Centralised - Variation EMEA/H/C/246/II/14 (2005)210 of 25/01/2005
03/02/2005 Centralised - Variation EMEA/H/C/246/IA/23
07/06/2005 Centralised - Variation EMEA/H/C/246/II/24 (2005)1735 of 03/06/2005
01/09/2005 Centralised - Variation EMEA/H/C/246/II/25 (2005)3388 of 30/08/2005
27/10/2005 Centralised - Variation EMEA/H/C/246/II/26 (2005)4259 of 25/10/2005
13/01/2006 Centralised - Variation EMEA/H/C/246/IA/28
Updated with Decision(2006)1341 of 29/03/2006
15/02/2006 Centralised - Variation EMEA/H/C/246/IA/30
Updated with Decision(2006)1341 of 29/03/2006
30/03/2006 Centralised - Variation EMEA/H/C/246/II/27 (2006)1341 of 29/03/2006
02/05/2006 Centralised - Variation EMEA/H/C/246/II/29 (2006)1801 of 27/04/2006
28/07/2006 Centralised - Variation EMEA/H/C/246/II/31 (2006)3433 of 25/07/2006
07/09/2006 Centralised - Variation EMEA/H/C/246/II/32 (2006)4064 of 01/09/2006
31/10/2006 Centralised - Variation EMEA/H/C/246/II/33 (2006)5243 of 27/10/2006
09/01/2007 Centralised - Variation EMEA/H/C/246/II/36 (2007)31 of 04/01/2007
05/06/2007 Centralised - Variation EMEA/H/C/246/II/34 (2007)2427 of 01/06/2007
28/06/2007 Centralised - Variation EMEA/H/C/246/II/38
13/07/2007 Centralised - Variation EMEA/H/C/246/II/37 (2007)3401 of 09/07/2007
30/08/2007 Centralised - Variation EMEA/H/C/246/IA/40
29/10/2007 Centralised - Variation EMEA/H/C/246/IB/41
05/11/2007 Centralised - Variation EMEA/H/C/246/II/35, 39 (2007)5379 of 30/10/2007
17/12/2007 Centralised - Variation EMEA/H/C/246/IA/43
10/04/2008 Centralised - Variation EMEA/H/C/246/II/42, 44 (2008)1386 of 08/04/2008
04/11/2008 Centralised - Variation EMEA/H/C/246/II/46 (2008)6659 of 31/10/2008
04/12/2008 Centralised - Variation EMEA/H/C/246/II/47 (2008)8007 of 02/12/2008
28/04/2009 Centralised - Renewal EMEA/H/C/246/R/50 (2009)3263 of 23/04/2009
13/11/2009 Centralised - Variation EMEA/H/C/246/II/45, 48, 49 (2009)9013 of 11/11/2009
30/04/2010 Centralised - Variation EMEA/H/C/246/IB/52
Updated with Decision(2010)4790 of 05/07/2010
13/07/2010 Centralised - Variation EMEA/H/C/246/II/51 (2010)4790 of 05/07/2010
14/07/2010 Centralised - Variation EMEA/H/C/246/IA/53/G
23/08/2010 Centralised - Variation EMEA/H/C/246/IB/54
Updated with Decision(2011)1648 of 08/03/2011
10/12/2010 Centralised - Variation EMEA/H/C/246/N/55
Updated with Decision(2011)1648 of 08/03/2011
21/03/2011 Centralised - Variation (2011)1648 of 08/03/2011
24/06/2011 Centralised - Variation EMEA/H/C/246/N/56
Updated with Decision(2011)6145 of 24/08/2011
01/07/2011 Centralised - Variation EMEA/H/C/246/WS/80 (2011)4805 of 29/06/2011
29/08/2011 Centralised - Variation EMEA/H/C/246/WS/124 (2011)6145 of 24/08/2011
18/01/2012 Centralised - Variation EMEA/H/C/246/IG/140
Updated with Decision(2012)2408 of 04/04/2012
04/04/2012 Centralised - Variation EMEA/H/C/246/WS/216 (2012)2326 of 30/03/2012
11/04/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/246/T/62 (2012)2408 of 04/04/2012
01/07/2013 Centralised - Variation EMEA/H/C/246/N/65
Updated with Decision(2014)2922 of 28/04/2014
21/11/2013 Centralised - Variation EMEA/H/C/246/II/66/G
Updated with Decision(2014)2922 of 28/04/2014
30/04/2014 Centralised - Modification EMEA/H/C/246/10007/201307 (2014)2922 of 28/04/2014