Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Tamiflu   
Auth. number : EU/1/02/222
INN : Oseltamivir
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: J05AH - Neuraminidase inhibitors
Chemical substance: J05AH02 - Oseltamivir
(See WHO ATC Index)
Indication: Treatment of influenza
In patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms. This indication is based on clinical studies of naturally occurring influenza in which the predominant infection was influenza A (see section 5.1).
Tamiflu is indicated for the treatment of infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2).
The treating physician should take into account the pathogenicity of the circulating strain and the underlying condition of the patient to ensure there is a potential benefit to the child.

Prevention of influenza
- Post-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community.
- The appropriate use of Tamiflu for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older.
- Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2).

Tamiflu is not a substitute for influenza vaccination.
The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations (see section 5.1).
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/402 (2002)2418 of 20/06/2002
24/09/2002 Centralised - Variation EMEA/H/C/402/I/1
09/01/2003 Centralised - Variation EMEA/H/C/402/I/4
19/06/2003 Centralised - Variation EMEA/H/C/402/I/7
11/11/2003 Centralised - Variation EMEA/H/C/402/II/5 (2003)4171 of 07/11/2003
29/01/2004 Centralised - Variation EMEA/H/C/402/II/8 (2004)241 of 27/01/2004
22/03/2004 Centralised - Variation EMEA/H/C/402/IB/10
Updated with Decision(2004)4466 of 16/11/2004
23/03/2004 Centralised - Variation EMEA/H/C/402/I/9
04/05/2004 Centralised - Variation EMEA/H/C/402/IB/11
27/09/2004 Centralised - Variation EMEA/H/C/402/N/12
Updated with Decision(2005)477 of 23/02/2005
18/11/2004 Centralised - Variation (2004)4466 of 16/11/2004
07/12/2004 Centralised - Variation EMEA/H/C/402/IB/14
Updated with Decision(2005)477 of 23/02/2005
28/01/2005 Centralised - Variation EMEA/H/C/402/IA/15
25/02/2005 Centralised - Variation EMEA/H/C/402/II/13 (2005)477 of 23/02/2005
01/04/2005 Centralised - Variation EMEA/H/C/402/IB/16
27/05/2005 Centralised - Variation EMEA/H/C/402/IB/17
27/05/2005 Centralised - Variation EMEA/H/C/402/IA/18
13/09/2005 Centralised - Variation EMEA/H/C/402/N/19
Updated with Decision(2006)153 of 20/01/2006
08/01/2006 Centralised - Variation EMEA/H/C/402/IA/22
24/01/2006 Centralised - Variation EMEA/H/C/402/II/21 (2006)153 of 20/01/2006
27/01/2006 Centralised - Variation EMEA/H/C/402/II/20 (2006)222 of 25/01/2006
15/02/2006 Centralised - Variation EMEA/H/C/402/IA/24
Updated with Decision(2006)4164 of 12/09/2006
10/03/2006 Centralised - Variation EMEA/H/C/402/IB/25
13/03/2006 Centralised - Variation EMEA/H/C/402/IB/23
23/06/2006 Centralised - Variation EMEA/H/C/402/IB/26
30/06/2006 Centralised - Variation EMEA/H/C/402/IA/29
03/07/2006 Centralised - Variation EMEA/H/C/402/IB/27
03/07/2006 Centralised - Variation EMEA/H/C/402/IB/28
01/08/2006 Centralised - Variation EMEA/H/C/402/IA/31
25/08/2006 Centralised - Variation EMEA/H/C/402/IB/30
29/08/2006 Centralised - Variation EMEA/H/C/402/IB/32
13/09/2006 Centralised - Variation EMEA/H/C/402/IB/34
13/09/2006 Centralised - Variation EMEA/H/C/402/IB/33
14/09/2006 Centralised - Variation (2006)4164 of 12/09/2006
09/10/2006 Centralised - Variation EMEA/H/C/402/IB/35
09/10/2006 Centralised - Variation EMEA/H/C/402/IB/37
09/10/2006 Centralised - Variation EMEA/H/C/402/IB/36
13/10/2006 Centralised - Variation EMEA/H/C/402/IA/38
31/10/2006 Centralised - Variation EMEA/H/C/402/IA/39
Updated with Decision(2007)1518 of 28/03/2007
09/01/2007 Centralised - Variation EMEA/H/C/402/IB/41
09/01/2007 Centralised - Variation EMEA/H/C/402/IB/42
30/03/2007 Centralised - Variation EMEA/H/C/402/II/43 (2007)1518 of 28/03/2007
24/05/2007 Centralised - Variation EMEA/H/C/402/IB/47
24/05/2007 Centralised - Variation EMEA/H/C/402/IB/46
03/07/2007 Centralised - Renewal EMEA/H/C/402/R/40 (2007)3248 of 29/06/2007
10/07/2007 Centralised - Variation EMEA/H/C/402/IB/48
Updated with Decision(2007)4302 of 13/09/2007
18/09/2007 Centralised - Variation EMEA/H/C/402/II/49 (2007)4302 of 13/09/2007
21/09/2007 Centralised - Variation EMEA/H/C/402/X/44, 45 (2007)4407 of 19/09/2007
26/10/2007 Centralised - Variation EMEA/H/C/402/II/50 (2007)5296 of 24/10/2007
26/11/2007 Centralised - Variation EMEA/H/C/402/IA/55
20/12/2007 Centralised - Variation EMEA/H/C/402/IA/58
20/06/2008 Centralised - Variation EMEA/H/C/402/I/57 (2008)30/70 of 18/06/2008
09/07/2008 Centralised - Variation EMEA/H/C/402/II/56 (2008)3557 of 07/07/2008
05/09/2008 Centralised - Variation EMEA/H/C/402/II/59 (2008)4979 of 03/09/2008
04/11/2008 Centralised - Variation EMEA/H/C/402/II/60 (2008)6655 of 31/10/2008
10/11/2008 Centralised - Variation EMEA/H/C/402/IA/64
18/11/2008 Centralised - Variation EMEA/H/C/402/IB/63
28/01/2009 Centralised - Variation EMEA/H/C/402/II/61, 62 (2009)553 of 26/01/2009
13/05/2009 Centralised - Variation EMEA/H/C/402/II/65 (2009)3901 of 11/05/2009
22/07/2009 Centralised - Variation EMEA/H/C/402/IB/66
15/09/2009 Centralised - Variation EMEA/H/C/402/II/67, 68 (2009)6965 of 09/09/2009
16/09/2009 Centralised - Variation EMEA/H/C/402/II/65 (2009)7051 corr of 14/09/2009
20/10/2009 Centralised - Variation EMEA/H/C/402/IA/73
27/10/2009 Centralised - Variation EMEA/H/C/402/II/70, 71 (2009)8393 of 23/10/2009
05/11/2009 Centralised - Variation EMEA/H/C/402/IB/72
03/12/2009 Centralised - Variation EMEA/H/C/402/IB/74
22/01/2010 Centralised - Variation EMEA/H/C/402/II/76 (2010)414 of 20/01/2010
11/03/2010 Centralised - Variation EMEA/H/C/402/IB/78
Updated with Decision(2010)2833 of 27/04/2010
17/03/2010 Centralised - Variation EMEA/H/C/402/II/69 (2010)1786 of 15/03/2010
29/04/2010 Centralised - Variation EMEA/H/C/402/II/77 (2010)2833 of 27/04/2010
07/07/2010 Centralised - Variation EMEA/H/C/402/II/79 (2010)4711 of 02/07/2010
09/09/2010 Centralised - Variation EMEA/H/C/402/IB/83/C
01/12/2010 Centralised - Variation EMEA/H/C/402/II/80, 82, 82 (2010)8560 of 26/11/2010
23/12/2010 Centralised - Variation EMEA/H/C/402/II/81 (2010)9627 of 20/12/2010
23/02/2011 Centralised - Variation EMEA/H/C/402/II/84 (2011)1191 of 21/02/2011
28/06/2011 Centralised - Variation EMEA/H/C/402/II/86 (2011)4631 of 23/06/2011
07/11/2011 Centralised - Variation EMEA/H/C/402/II/87, 88/G (2011)8061 of 03/11/2011
30/11/2011 Centralised - Variation EMEA/H/C/402/X/85 (2011)8960 of 28/11/2011
24/05/2012 Centralised - Renewal EMEA/H/C/402/R/89 (2012)3461 of 22/05/2012
25/05/2012 Centralised - Renewal EMEA/H/C/402/R/89 (2012)3460 of 22/05/2012
12/09/2012 Centralised - Variation EMEA/H/C/402/II/94 (2012)6396 of 10/09/2012
03/10/2012 Referral EMEA/H/C/402/A-20/93 (2012)7051 of 01/10/2012
15/11/2012 Centralised - Variation EMEA/H/C/402/II/96
Updated with Decision(2013)8905 of 04/12/2013
24/10/2013 Centralised - Variation EMEA/H/C/402/II/101/G
Updated with Decision(2013)8905 of 04/12/2013
06/12/2013 Centralised - Variation (2013)8905 of 04/12/2013