Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Yellox   
Auth. number : EU/1/11/692
Active substance : bromfenac
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01B - Antiinflammatory agents
Chemical subgroup: S01BC - Antiinflammatory agents, non-steroids
Chemical substance: S01BC11 - Bromfenac
(See WHO ATC Index)
Indication: Treatment of postoperative ocular inflammation following cataract extraction in adults
Marketing Authorisation Holder: PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c 17000 Praha 7 Česká republika
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
23/05/2011 Centralised - Authorisation EMEA/H/C/1198 (2011)3612 of 18/05/2011
20/07/2011 Centralised - Variation EMEA/H/C/1198/IB/1
Updated with Decision(2012)820 of 06/02/2012
07/12/2011 Centralised - Variation EMEA/H/C/1198/IB/2
Updated with Decision(2012)820 of 06/02/2012
09/02/2012 Centralised - Variation (2012)820 of 06/02/2012
14/08/2014 Centralised - Variation
Updated with Decision(2015)464 of 27/01/2015
29/01/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1198/T/11 (2015)464 of 27/01/2015
02/03/2015 PSUSA - Modification EMEA/H/C/1198/PSUV/10 (2015)1425 of 26/02/2015