European Commission
Public Health
Accessibility tools
Service tools
Language selector
- Current languageen
Navigation path
Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Emadine
|
| Auth. number : | EU/1/98/095 |
| INN : | emedastine |
| ATC: | S - Sensory organs S01 - Ophthalmologicals S01G - Decongestants and antiallergics S01GX - Other antiallergics 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
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 22/03/1999 | Centralised - Variation | 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 | EMEA/H/C/223/I/7 | ||||
| 13/09/2000 | Centralised - Variation | EMEA/H/C/223/I/6 | ||||
| 13/09/2000 | Centralised - Variation | EMEA/H/C/223/I/5 | ||||
| 13/09/2000 | Centralised - Variation | EMEA/H/C/223/I/3 | ||||
| 13/09/2000 | Centralised - Variation | EMEA/H/C/223/I/4 | ||||
| 13/09/2000 | Centralised - Variation | EMEA/H/C/223/I/8 | ||||
| 05/06/2002 | Centralised - Variation | EMEA/H/C/223/X/9 | (2002)2049 of 30/05/2002 | |||
| 25/06/2002 | Centralised - Variation | 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 | |||
| 29/01/2004 | Centralised - Authorisation | EMEA/H/C/223 | (1999)177 of 27/01/1999 | |||
| 09/03/2004 | Centralised - Renewal | EMEA/H/C/223/R/13 | (2004)795 of 05/03/2004 | |||
| 19/07/2004 | Centralised - Variation | EMEA/H/C/223/N/14 | ||||
| Updated with Decision(2009)139 of 13/01/2009 | ||||||
| 24/11/2004 | Centralised - Variation | EMEA/H/C/223/N/15 | ||||
| Updated with Decision(2009)139 of 13/01/2009 | ||||||
| 20/02/2007 | Centralised - Variation | EMEA/H/C/223/N/16 | ||||
| Updated with Decision(2009)139 of 13/01/2009 | ||||||
| 21/11/2007 | Centralised - Variation | EMEA/H/C/223/II/17 | ||||
| 29/08/2008 | Centralised - Variation | EMEA/H/C/223/IB/19 | ||||
| 29/08/2008 | Centralised - Variation | EMEA/H/C/223/IB/20 | ||||
| 04/09/2008 | Centralised - Variation | 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 | EMEA/H/C/223/IA/23 | ||||
| 05/02/2009 | Centralised - Variation | EMEA/H/C/223/IA/24 | ||||
| 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 | EMEA/H/C/223/II/25 | ||||
| 09/09/2010 | Centralised - Variation | - | (2010)6236 of 06/09/2010 | |||
| 30/11/2010 | Centralised - Variation | EMEA/H/C/223/N/27 | ||||
| 19/03/2013 | Centralised - Variation | EMEA/H/C/223/IG/274 | ||||