Pharmaceuticals - Union Register


Union Register of medicinal products for human use


Product information

Invented name: ZINPLAVA   
Auth. number : EU/1/16/1156
Active substance : bezlotoxumab
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J06 - Immune sera and immunoglobulins
Pharmacological subgroup: J06B - Immunoglobulins
Chemical subgroup: J06BB - Specific immunoglobulins
Chemical substance: J06BB21 - bezlotoxumab
(See WHO ATC Index)
Indication: ZINPLAVA is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI
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
20/01/2017 Centralised - Authorisation EMEA/H/C/4136 (2017)340 of 18/01/2017
30/03/2017 Centralised - Notification EMEA/H/C/4136/N/1
Updated with Decision(2018)3915 of 15/06/2018
4/09/2017 Centralised - Variation EMEA/H/C/4136/IB/3
Updated with Decision(2018)3915 of 15/06/2018
21/03/2018 Centralised - Variation EMEA/H/C/4136/IB/9
Updated with Decision(2018)3915 of 15/06/2018
19/06/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/4136/T/11 (2018)3915 of 15/06/2018