Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Travatan   
Auth. number : EU/1/01/199
Active substance : Travoprost
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01E - Antiglaucoma preparations and miotics
Chemical subgroup: S01EE - Prostaglandin analogues
Chemical substance: S01EE04 - Travoprost
(See WHO ATC Index)
Indication: Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma.
Decrease of elevated intraocular pressure in paediatric patients aged 2 months to < 18 years with ocular hypertension or paediatric glaucoma
Marketing Authorisation Holder: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, 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
29/11/2001 Centralised - Authorisation EMEA/H/C/390 (2001)3865 of 27/11/2001
15/02/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/I/1
18/03/2002 Centralised - Notification EMEA/H/C/390/N/2 (2002)1177 of 14/03/2002
05/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/I/3
24/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/I/4
14/11/2002 Centralised - Variation EMEA/H/C/390/II/5 (2002)4504 of 12/11/2002
18/02/2003 Centralised - Variation EMEA/H/C/390/I/7 (2003)594 of 14/02/2003
26/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/I/8
30/07/2003 Centralised - Variation EMEA/H/C/390/II/6 (2003)2820 of 28/07/2003
28/10/2003 Centralised - Variation EMEA/H/C/390/II/9 (2003)4030 of 24/10/2003
14/05/2004 Centralised - Notification EMEA/H/C/390/N/10
Updated with Decision(2005)208 of 25/01/2005
24/11/2004 Centralised - Notification EMEA/H/C/390/N/12
Updated with Decision(2005)208 of 25/01/2005
27/01/2005 Centralised - Variation EMEA/H/C/390/II/13 (2005)208 of 25/01/2005
05/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/IB/14
26/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/IB/15
10/10/2006 Centralised - Renewal EMEA/H/C/390/R/16 (2006)4846 of 06/10/2006
08/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/IB/18
25/01/2007 Centralised - Notification EMEA/H/C/390/N/19
Updated with Decision(2007)762 of 01/03/2007
05/03/2007 Centralised - Variation EMEA/H/C/390/II/17 (2007)762 of 01/03/2007
21/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/II/20
12/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/IB/21
02/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/IB/23
02/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/IB/24
06/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/IA/25
21/01/2009 Centralised - Notification EMEA/H/C/390/N/26
Updated with Decision(2010)7624 of 28/10/2010
19/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/IB/28
19/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/IB/27
05/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/II/29
07/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/II/30
09/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/IB/31
08/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/IA/33
08/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/390/IA/34
04/11/2010 Centralised - Variation EMEA/H/C/390/II/32 (2010)7624 of 28/10/2010
02/12/2010 Centralised - Variation EMEA/H/C/390/II/35/G (2010)8653 of 29/11/2010
18/04/2011 Centralised - Variation EMEA/H/C/390/II/36 (2011)2787 of 14/04/2011
17/01/2013 Centralised - Variation EMEA/H/C/390/II/39
Updated with Decision(2014)637 of 31/01/2014
19/03/2013 Centralised - Variation EMEA/H/C/390/IG/274
Updated with Decision(2014)637 of 31/01/2014
01/07/2013 Centralised - Notification EMEA/H/C/390/N/43
Updated with Decision(2014)637 of 31/01/2014
04/02/2014 Centralised - Yearly update (2014)637 of 31/01/2014
25/04/2014 Centralised - Variation EMEA/H/C/390/II/44
Updated with Decision(2014)10236 of 19/12/2014
23/12/2014 Centralised - 2-Monthly update EMEA/H/C/390/II/46 (2014)10236 of 19/12/2014
22/01/2015 Centralised - Variation EMEA/H/C/390/II/49/G
Updated with Decision(2016)454 of 25/01/2016
26/03/2015 Centralised - Variation EMEA/H/C/390/IA/50
Updated with Decision(2016)454 of 25/01/2016
27/01/2016 Centralised - Yearly update (2016)454 of 25/01/2016
21/04/2017 Centralised - Variation EMEA/H/C/390/II/53
24/04/2017 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/390/T/56 (2017) 2773 of 20/04/2017
12/05/2017 Corrigendum (2017) 2773 of 20/04/2017