Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Viread   
Auth. number : EU/1/01/200
INN : tenofovir disoproxil fumarate
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: J05AF - Nucleoside and nucleotide reverse transcriptase inhibitors
Chemical substance: J05AF07 - Tenofovir disoproxil
(See WHO ATC Index)
Indication: Viread 123 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 17 kg to less than 22 kg.
The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.

Viread 163 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 22 kg to less than 28 kg.
The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.

Viread 204 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 28 kg to less than 35 kg.
The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.

Viread 245 mg film coated tablets
- HIV 1 infection
Viread 245 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected adults.
In adults, the demonstration of the benefit of Viread in HIV 1 infection is based on results of one study in treatment naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).
Viread 245 mg film coated tablets are also indicated for the treatment of HIV 1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.
The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.

- Hepatitis B infection
Viread 245 mg film coated tablets are indicated for the treatment of chronic hepatitis B in adults with:
• compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
• evidence of lamivudine resistant hepatitis B virus.
• decompensated liver disease.
Viread 245 mg film coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with:
• compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis.

Viread 33 mg/g granules
- HIV 1 infection
Viread 33 mg/g granules are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, from 2 to < 6 years of age, and above 6 years of age for whom a solid dosage form is not appropriate.
Viread 33 mg/g granules are also indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected adults for whom a solid dosage form is not appropriate.
In adults, the demonstration of the benefit of Viread in HIV 1 infection is based on results of one study in treatment naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).
The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients.

- Hepatitis B infection
Viread 33 mg/g granules are indicated for the treatment of chronic hepatitis B in adults for whom a solid dosage form is not appropriate with:
• compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1).
• evidence of lamivudine resistant hepatitis B virus.
• decompensated liver disease.
Viread 33 mg/g granules are also indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age for whom a solid dosage form is not appropriate with:
• compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis.
Marketing Authorisation Holder: Gilead Sciences International Limited
Cambridge CB21 6GT, 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
07/02/2002 Centralised - Authorisation EMEA/H/C/419 (2002)483 of 05/02/2002
08/03/2002 Centralised - Variation EMEA/H/C/419/I/1
12/04/2002 Centralised - Variation EMEA/H/C/419/I/2, 3, 4
30/08/2002 Centralised - Variation EMEA/H/C/419/I/5
12/12/2002 Centralised - Variation EMEA/H/C/419/I/11
24/12/2002 Centralised - Variation EMEA/H/C/419/II/6 (2002)5002 of 05/12/2002
10/02/2003 Centralised - Variation EMEA/H/C/419/N/12 (2003)505 of 06/02/2003
04/03/2003 Centralised - Variation EMEA/H/C/419/I/16, 17
31/03/2003 Centralised - Variation EMEA/H/C/419/II/10 (2003)1144 of 27/03/2003
22/05/2003 Centralised - Variation EMEA/H/C/419/II/7, 8, 9 (2003)1724 of 19/05/2003
11/06/2003 Centralised - Variation EMEA/H/C/419/I/22
14/07/2003 Centralised - Variation EMEA/H/C/419/II/19 (2003)2596 of 10/07/2003
15/07/2003 Centralised - Variation EMEA/H/C/419/II/13, 14, 15 (2003)2548 of 09/07/2003
15/07/2003 Centralised - Variation EMEA/H/C/419/I/21 (2003)2556 of 09/07/2003
18/07/2003 Centralised - Variation EMEA/H/C/419/I/23, 25, 26, 27, 28
05/08/2003 Centralised - Annual reassessment EMEA/H/C/419/S/20 (2003)2903 of 01/08/2003
17/09/2003 Centralised - Variation EMEA/H/C/419/I/31
22/10/2003 Centralised - Variation EMEA/H/C/419/II/18 (2003)3941 of 17/10/2003
16/01/2004 Centralised - Variation EMEA/H/C/419/II/29 (2004)92 of 14/01/2004
03/02/2004 Centralised - Variation EMEA/H/C/419/II/30 (2004)305 of 30/01/2004
03/02/2004 Centralised - Variation EMEA/H/C/419/II/32 (2004)304 of 30/01/2004
05/05/2004 Centralised - Variation EMEA/H/C/419/IB/36
14/06/2004 Centralised - Variation EMEA/H/C/419/II/34 (2004)2113 of 10/06/2004
15/06/2004 Centralised - Variation EMEA/H/C/419/II/33 (2004)2112 of 10/06/2004
29/06/2004 Centralised - Variation EMEA/H/C/419/IB/37
14/07/2004 Centralised - Variation EMEA/H/C/419/IB/38
04/08/2004 Centralised - Annual reassessment EMEA/H/C/419/S/35 (2004)3043 of 02/08/2004
16/08/2004 Centralised - Variation EMEA/H/C/419/N/40
Updated with Decision(2004)4308 of 28/10/2004
04/10/2004 Centralised - Variation EMEA/H/C/419/IA/42
01/11/2004 Centralised - Variation EMEA/H/C/419/II/41 (2004)4308 of 28/10/2004
11/11/2004 Centralised - Variation EMEA/H/C/419/IA/45
08/12/2004 Centralised - Variation EMEA/H/C/419/II/39 (2004)4852 of 06/12/2004
12/01/2005 Centralised - Variation EMEA/H/C/419/II/43 (2005)68 of 10/01/2005
27/01/2005 Centralised - Variation EMEA/H/C/419/IB/47
Updated with Decision(2005)2745 of 08/07/2005
22/02/2005 Centralised - Variation EMEA/H/C/419/II/46
09/03/2005 Centralised - Variation EMEA/H/C/419/II/44 (2005)669 of 07/03/2005
08/04/2005 Centralised - Variation EMEA/H/C/419/N/49
Updated with Decision(2005)2745 of 08/07/2005
28/04/2005 Centralised - Variation EMEA/H/C/419/IA/50
06/07/2005 Centralised - Variation EMEA/H/C/419/IA/51
12/07/2005 Centralised - Annual reassessment EMEA/H/C/419/S/48 (2005)2745 of 08/07/2005
22/07/2005 Centralised - Variation EMEA/H/C/419/IB/52
27/10/2005 Centralised - Variation EMEA/H/C/419/II/53 (2005)4263 of 25/10/2005
13/01/2006 Centralised - Variation EMEA/H/C/419/IA/55
23/01/2006 Centralised - Variation EMEA/H/C/419/N/56
Updated with Decision(2006)698 of 28/02/2006
07/02/2006 Centralised - Variation EMEA/H/C/419/IA/58
07/02/2006 Centralised - Variation EMEA/H/C/419/IA/57
02/03/2006 Centralised - Variation EMEA/H/C/419/II/54 (2006)698 of 28/02/2006
14/07/2006 Centralised - Variation EMEA/H/C/419/IA/62
24/08/2006 Centralised - Variation EMEA/H/C/419/IB/64
24/08/2006 Centralised - Variation EMEA/H/C/419/IB/63
07/09/2006 Centralised - Variation EMEA/H/C/419/II/59 (2006)4061 of 01/09/2006
10/01/2007 Centralised - Renewal EMEA/H/C/419/R/61 (2007)72 of 08/01/2007
18/01/2007 Centralised - Variation EMEA/H/C/419/II/65 (2007)164 of 15/01/2007
02/03/2007 Centralised - Variation EMEA/H/C/419/II/66 (2007)749 of 28/02/2007
14/03/2007 Centralised - Variation EMEA/H/C/419/IB/70
14/03/2007 Centralised - Variation EMEA/H/C/419/IA/71
Updated with Decision(2007)2023 of 02/05/2007
14/03/2007 Centralised - Variation EMEA/H/C/419/IB/69
24/04/2007 Centralised - Variation EMEA/H/C/419/IA/72
04/05/2007 Centralised - Variation EMEA/H/C/419/II/67, 68 (2007)2023 of 02/05/2007
24/10/2007 Centralised - Variation EMEA/H/C/419/I/73
24/10/2007 Centralised - Variation EMEA/H/C/419/I/74
20/12/2007 Centralised - Variation EMEA/H/C/419/IA/77
Updated with Decision(2008)1697 of 23/04/2008
28/02/2008 Centralised - Variation EMEA/H/C/419/IA/78
14/03/2008 Centralised - Variation EMEA/H/C/419/IB/79
Updated with Decision(2008)1697 of 23/04/2008
25/04/2008 Centralised - Variation EMEA/H/C/419/II/75 (2008)1697 of 23/04/2008
14/05/2008 Centralised - Variation EMEA/H/C/419/IA/81
Updated with Decision(2008)5169 of 12/09/2008
15/09/2008 Centralised - Variation EMEA/H/C/419/II/82 (2008)5169 of 12/09/2008
19/09/2008 Centralised - Variation EMEA/H/C/419/IA/83
22/09/2008 Centralised - Variation EMEA/H/C/419/IA/84
20/10/2008 Centralised - Variation EMEA/H/C/419/N/85
Updated with Decision(2009)3182 of 22/04/2009
21/10/2008 Centralised - Variation EMEA/H/C/419/IA/86
09/01/2009 Centralised - Variation EMEA/H/C/419/IB/87
16/02/2009 Centralised - Variation EMEA/H/C/419/IA/91
16/02/2009 Centralised - Variation EMEA/H/C/419/IA/90
24/04/2009 Centralised - Variation EMEA/H/C/419/II/88, 89 (2009)3182 of 22/04/2009
02/06/2009 Centralised - Variation EMEA/H/C/419/IA/95
23/06/2009 Centralised - Variation EMEA/H/C/419/IB/93
27/07/2009 Centralised - Variation EMEA/H/C/419/IB/94
Updated with Decision(2010)1823 of 15/03/2010
18/03/2010 Centralised - Variation (2010)1823 of 15/03/2010
13/04/2010 Centralised - Variation EMEA/H/C/419/II/96 (2010)2414 of 09/04/2010
12/08/2010 Centralised - Variation EMEA/H/C/419/IA/99
Updated with Decision(2011)1929 of 18/03/2011
09/09/2010 Centralised - Variation EMEA/H/C/419/II/92, 97 (2010)6252 of 06/09/2010
20/10/2010 Centralised - Variation EMEA/H/C/419/IB/100
Updated with Decision(2011)1929 of 18/03/2011
29/10/2010 Centralised - Variation EMEA/H/C/419/WS/47
23/03/2011 Centralised - Variation (2011)1929 of 18/03/2011
24/03/2011 Centralised - Variation EMEA/H/C/419/IG/47/G
Updated with Decision(2011)3614 of 18/05/2011
29/03/2011 Centralised - Variation EMEA/H/C/419/II/98 (2011)2096 of 24/03/2011
02/05/2011 Centralised - Variation EMEA/H/C/419/IA/102
Updated with Decision(2011)5205 of 13/07/2011
23/05/2011 Centralised - Variation (2011)3614 of 18/05/2011
18/07/2011 Centralised - Variation EMEA/H/C/419/II/101 (2011)5205 of 13/07/2011
10/08/2011 Centralised - Variation EMEA/H/C/419/WS/115 (2011)5844 of 05/08/2011
19/12/2011 Centralised - Renewal EMEA/H/C/419/R/103 (2011)9759 of 14/12/2011
02/02/2012 Centralised - Variation EMEA/H/C/419/II/104 (2012)650 of 31/01/2012
27/11/2012 Centralised - Variation EMEA/H/C/419/X/105/G, EMEA/H/C/419/II/115 (2012)8713 of 22/11/2012
27/03/2013 Centralised - Variation EMEA/H/C/419/IAin/125
Updated with Decision(2013)4239 of 01/07/2013
10/04/2013 Centralised - Variation EMEA/H/C/419/N/124
Updated with Decision(2013)4239 of 01/07/2013
01/05/2013 Centralised - Variation EMEA/H/C/419/II/120 (2013)2646 of 29/04/2013
03/07/2013 Centralised - Variation EMEA/H/C/419/WS/391 (2013)4239 of 01/07/2013
25/07/2013 Centralised - Variation EMEA/H/C/419/II/128
Updated with Decision(2013)7046 of 18/10/2013
22/10/2013 Centralised - Variation EMEA/H/C/419/II/121, EMEA/H/C/419/II/123/G (2013)7046 of 18/10/2013