Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Trulicity   
Auth. number : EU/1/14/956
Active substance : dulaglutide
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A10 - Drugs used in diabetes
Pharmacological subgroup: A10B - Blood glucose lowering drugs, excluding insulins
Chemical subgroup: A10BJ - Glucagon-like peptide-1 (GLP-1) analogues
Chemical substance: A10BJ05 - dulaglutide
(See WHO ATC Index)
Indication: Trulicity is indicated in adults with type 2 diabetes mellitus to improve glycaemic control as:

Monotherapy
When diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.

Add-on therapy
In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 for data with respect to different combinations).
Marketing Authorisation Holder: Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, 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 Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
25/11/2014 Centralised - Authorisation EMEA/H/C/2825 (2014)9038 of 21/11/2014
10/08/2015 Centralised - Notification EMEA/H/C/2825/N/4
Updated with Decision(2016)5967 of 15/09/2016
24/09/2015 Centralised - Variation EMEA/H/C/2825/II/6/G
Updated with Decision(2016)5967 of 15/09/2016
23/02/2016 Centralised - Variation EMEA/H/C/2825/IG/662
Updated with Decision(2016)5967 of 15/09/2016
19/09/2016 Centralised - Yearly update (2016)5967 of 15/09/2016
13/10/2016 Centralised - Variation EMEA/H/C/2825/II/12
Updated with Decision(2016)8690 of 12/12/2016
13/10/2016 Centralised - Variation EMEA/H/C/2825/II/13
Updated with Decision(2016)8690 of 12/12/2016
14/12/2016 PSUSA - Modification EMEA/H/C/PSUSA/10311/201603 (2016)8690 of 12/12/2016
20/06/2017 PSUSA - Modification EMEA/H/C/PSUSA/10311/201609 (2017)4311 of 16/06/2017
12/02/2018 Centralised - Variation EMEA/H/C/2825/IG/898
Updated with Decision(2018)4339 of 02/07/2018
26/02/2018 Centralised - 2-Monthly update EMEA/H/C/2825/II/22 (2018)1236 of 22/02/2018
27/03/2018 Centralised - Variation EMEA/H/C/2825/IAIN/29
Updated with Decision(2018)4339 of 02/07/2018
26/04/2018 Centralised - Variation EMEA/H/C/2825/II/25
Updated with Decision(2018)4339 of 02/07/2018
3/07/2018 PSUSA - Modification EMEA/H/C/2825/PSUSA/10311/201709 (2018)4339 of 2/07/2018