Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zerbaxa   
Auth. number : EU/1/15/1032
Active substance : ceftolozane / tazobactam
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J01 - Antibacterials for systemic use
Pharmacological subgroup: J01D - Other beta-lactam antibacterials
Chemical subgroup: J01DI - Other cephalosporins
Chemical substance: J01DI54 - ceftolozane and enzyme inhibitor
(See WHO ATC Index)
Indication: Zerbaxa is indicated for the treatment of the following infections in adults:

- Complicated intra abdominal infections ;
- Acute pyelonephritis;
- Complicated urinary tract infections
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Marketing Authorisation Holder: Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland
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 Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
22/09/2015 Centralised - Authorisation EMEA/H/C/3772 (2015)6545 of 18/09/2015
6/11/2015 Centralised - Variation EMEA/H/C/3772/IA/1
Updated with Decision(2016)6776 of 14/10/2016
15/01/2016 Centralised - Variation EMEA/H/C/3772/IB/2
Updated with Decision(2016)6776 of 14/10/2016
14/04/2016 Centralised - Variation EMEA/H/C/3772/II/3
Updated with Decision(2016)6776 of 14/10/2016
15/09/2016 Centralised - Variation EMEA/H/C/3772/IAIN/5
Updated with Decision(2016)6776 of 14/10/2016
18/10/2016 Centralised - Yearly update (2016)6776 of 14/10/2016
2/06/2017 Centralised - Variation EMEA/H/C/3772/IA/9
Updated with Decision(2018)2997 of 08/05/2018
6/03/2018 Centralised - Notification EMEA/H/C/3772/N/16
Updated with Decision(2018)2997 of 08/05/2018
15/05/2018 Centralised - Yearly update (2018)2997 of 8/05/2018
19/06/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/3772/T/17 (2018)3914 of 15/06/2018
27/11/2018 Centralised - Variation EMEA/H/C/3772/IA/19