Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: JETREA   
Auth. number : EU/1/13/819
Active substance : ocriplasmin
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01X - Other ophthalmologicals
Chemical subgroup: S01XA - Other ophthalmologicals
Chemical substance: S01XA22 - ocriplasmin
(See WHO ATC Index)
Indication: JETREA is indicated in adults for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns
Marketing Authorisation Holder: ThromboGenics NV
Gaston Geenslaan 1, 3001 Leuven, België
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
15/03/2013 Centralised - Authorisation EMEA/H/C/2381 (2013)1648 of 13/03/2013
11/11/2013 Centralised - Variation EMEA/H/C/2381/IA/4/G
Updated with Decision(2014)8287 of 30/10/2014
21/11/2013 Centralised - Variation EMEA/H/C/2381/IB/5
Updated with Decision(2014)8287 of 30/10/2014
13/02/2014 Centralised - Notification EMEA/H/C/2381/N/9
Updated with Decision(2014)8287 of 30/10/2014
20/03/2014 Centralised - Variation EMEA/H/C/2381/II/7
Updated with Decision(2014)8287 of 30/10/2014
22/10/2014 Centralised - Variation EMEA/H/C/2381/IB/16
Updated with Decision(2015)2896 of 24/04/2015
03/11/2014 Centralised - Yearly update (2014)8287 of 30/10/2014
28/04/2015 Centralised - Variation EMEA/H/C/2381/X/13 (2015)2896 of 24/04/2015
22/07/2015 PSUSA - Modification EMEA/H/C/2381/PSUSA/10122 (2015)5151 of 17/07/2015
10/11/2016 Centralised - Variation EMEA/H/C/2381/II/26
Updated with Decision(2017)7021 of 13/10/2017
06/02/2017 Centralised - Notification EMEA/H/C/2381/N/32
Updated with Decision(2017)7021 of 13/10/2017
02/08/2017 Centralised - Notification EMEA/H/C/2381/N/35
Updated with Decision(2017)7021 of 13/10/2017
17/10/2017 Centralised - Yearly update (2017)7021 of 13/10/2017
12/12/2017 Centralised - Renewal EMEA/H/C/2381/R/33 (2017)8603 of 08/12/2017