Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Rebetol   
Auth. number : EU/1/99/107
Active substance : 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 is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1).

Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation (see sections 4.2, 4.4 and 5.1).
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
16/07/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/246/I/1
16/07/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/246/I/2
11/05/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/246/I/4
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 (no change in Commission Decision) EMEA/H/C/246/I/7
26/06/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/246/II/6
07/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/246/II/9
14/02/2002 Centralised - Notification 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 (no change in Commission Decision) EMEA/H/C/246/I/12, 13
29/09/2003 Centralised - Variation (no change in Commission Decision) 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 - Notification EMEA/H/C/246/N/17 (2003)5024 of 12/12/2003
29/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/246/IB/20
02/07/2004 Centralised - Notification 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 (no change in Commission Decision) EMEA/H/C/246/II/22
27/01/2005 Centralised - Variation EMEA/H/C/246/II/14 (2005)210 of 25/01/2005
27/01/2005 Centralised - Variation EMEA/H/C/246/X/16 (2005)211 of 25/01/2005
03/02/2005 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/246/IA/40
29/10/2007 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) 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 (no change in Commission Decision) 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 - Notification 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 - Notification 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 - Notification 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 PSUSA - Modification EMEA/H/C/246/10007/201307 (2014)2922 of 28/04/2014
30/10/2015 Centralised - 2-Monthly update EMEA/H/C/246/II/74 (2015)7589 of 28/10/2015