Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Opatanol   
Auth. number : EU/1/02/217
Active substance : Olopatadine
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01G - Decongestants and antiallergics
Chemical subgroup: S01GX - Other antiallergics
Chemical substance: S01GX09 - Olopatadine
(See WHO ATC Index)
Indication: Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis
Marketing Authorisation Holder: Alcon Laboratories (UK) Ltd
Frimley Business Park, Frimley, Camberley, Surrey, 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
22/05/2002 Centralised - Authorisation EMEA/H/C/407 (2002)1958 of 17/05/2002
11/04/2003 Centralised - Variation EMEA/H/C/407/I/1 (2003)1248 of 09/04/2003
13/05/2004 Centralised - Notification EMEA/H/C/407/N/2
Updated with Decision(2007)2257 of 22/05/2007
24/11/2004 Centralised - Notification EMEA/H/C/407/N/3
Updated with Decision(2007)2257 of 22/05/2007
27/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/407/IB/5
29/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/407/IB/6, 7
22/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/407/IB/8
20/02/2007 Centralised - Notification EMEA/H/C/407/N/10
Updated with Decision(2007)2257 of 22/05/2007
24/05/2007 Centralised - Renewal EMEA/H/C/407/R/9 (2007)2257 of 22/05/2007
23/08/2007 Centralised - Variation EMEA/H/C/407/II/11 (2007)4019 of 21/08/2007
22/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/407/II/12
29/07/2008 Corrigendum (2007)4019 corr of 21/08/2007
19/01/2009 Centralised - Notification EMEA/H/C/407/N/13
Updated with Decision(2014)1503 of 03/03/2014
16/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/407/IA/14
27/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/407/II/15
12/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/407/II/16
04/10/2010 Centralised - Notification EMEA/H/C/407/N/17
Updated with Decision(2014)1503 of 03/03/2014
27/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/407/WS/75
19/03/2013 Centralised - Variation EMEA/H/C/407/IG/274
Updated with Decision(2014)1503 of 03/03/2014
02/07/2013 Centralised - Notification EMEA/H/C/407/N/25
Updated with Decision(2014)1503 of 03/03/2014
24/10/2013 Centralised - Variation EMEA/H/C/407/II/27/G
Updated with Decision(2014)1503 of 03/03/2014
09/01/2014 Centralised - Notification EMEA/H/C/407/N/28
Updated with Decision(2014)1503 of 03/03/2014
05/03/2014 Centralised - Yearly update (2014)1503 of 03/03/2014