Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Emadine   
Auth. number : EU/1/98/095
Active substance : emedastine
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01G - Decongestants and antiallergics
Chemical subgroup: S01GX - Other antiallergics
Chemical substance: S01GX06 - Emedastine
(See WHO ATC Index)
Indication: Symptomatic treatment 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
29/01/1999 Centralised - Authorisation EMEA/H/C/223 (1999)177 of 27/01/1999
22/03/1999 Centralised - Notification EMEA/H/C/223/N/1 (1999)694 of 16/03/1999
31/05/2000 Centralised - Variation EMEA/H/C/223/I/2 (2000)1450 of 31/05/2000
13/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/223/I/5
13/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/223/I/3
13/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/223/I/8
13/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/223/I/7
13/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/223/I/4
13/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/223/I/6
05/06/2002 Centralised - Variation EMEA/H/C/223/X/9 (2002)2049 of 30/05/2002
25/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/223/I/10
22/05/2003 Centralised - Variation EMEA/H/C/223/II/11 (2003)1720 of 19/05/2003
18/09/2003 Centralised - Variation EMEA/H/C/223/I/12 (2003)3330 of 16/09/2003
09/03/2004 Centralised - Renewal EMEA/H/C/223/R/13 (2004)795 of 05/03/2004
19/07/2004 Centralised - Notification EMEA/H/C/223/N/14
Updated with Decision(2009)139 of 13/01/2009
24/11/2004 Centralised - Notification EMEA/H/C/223/N/15
Updated with Decision(2009)139 of 13/01/2009
20/02/2007 Centralised - Notification EMEA/H/C/223/N/16
Updated with Decision(2009)139 of 13/01/2009
21/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/223/II/17
29/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/223/IB/19
29/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/223/IB/20
04/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/223/IB/22
15/01/2009 Centralised - Renewal EMEA/H/C/223/R/18 (2009)139 of 13/01/2009
05/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/223/IA/24
05/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/223/IA/23
25/01/2010 Centralised - Variation EMEA/H/C/223/IB/26
Updated with Decision(2010)6236 of 06/09/2010
19/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/223/II/25
09/09/2010 Centralised - Variation (2010)6236 of 06/09/2010
30/11/2010 Centralised - Notification EMEA/H/C/223/N/27
Updated with Decision(2014)1620 of 05/03/2014
19/03/2013 Centralised - Variation EMEA/H/C/223/IG/274
Updated with Decision(2014)1620 of 05/03/2014
18/07/2013 Centralised - Notification EMEA/H/C/223/N/35
Updated with Decision(2014)1620 of 05/03/2014
10/03/2014 Centralised - Yearly update (2014)1620 of 05/03/2014
20/03/2014 Centralised - Variation EMEA/H/C/223/II/37
Updated with Decision(2015)1909 of 16/03/2015
18/03/2015 Centralised - Yearly update (2015)1909 of 16/03/2015
06/01/2016 Centralised - Variation EMEA/H/C/223/IA/40