Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Envarsus   
Auth. number : EU/1/14/935
Active substance : tacrolimus
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AD - Calcineurin inhibitors
Chemical substance: L04AD02 - tacrolimus
(See WHO ATC Index)
Indication: Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients
Marketing Authorisation Holder: Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia
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
22/07/2014 Centralised - Authorisation EMEA/H/C/2655 (2014)5253 of 18/07/2014
22/12/2014 Centralised - Variation EMEA/H/C/2655/IA/1
Updated with Decision(2015)9550 of 14/12/2015
20/08/2015 Centralised - Variation EMEA/H/C/2655/IAin/5
Updated with Decision(2015)9550 of 14/12/2015
16/12/2015 Centralised - Yearly update (2015)9550 of 14/12/2015
29/01/2016 Corrigendum (2015)9550 of 14/12/2015
11/04/2016 Centralised - Variation EMEA/H/C/2655/IB/7
Updated with Decision(2017)2529 of 11/04/2017
21/02/2017 Centralised - Variation EMEA/H/C/2655/IA/9
Updated with Decision(2017)2529 of 11/04/2017
13/04/2017 Centralised - Yearly update (2017)2529 of 11/04/2017
05/05/2017 Centralised - Notification EMEA/H/C/2655/N/11