Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Ofev   
Auth. number : EU/1/14/979
Active substance : Nintedanib
Orphan market exclusivity for "Treatment of idiopathic pulmonary fibrosis" (based on designation EU/3/13/1123) started on 19/01/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 19/01/2025
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE31 - Nintedanib
(See WHO ATC Index)
Indication: Indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF)
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland
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
19/01/2015 Centralised - Authorisation EMEA/H/C/3821 (2015)234 of 15/01/2015
14/08/2015 Rectificative Decision (2015)5849 of 12/08/2015
26/01/2016 PSUSA - Modification EMEA/H/C/PSUSA/10319/201504 (2016)418 of 22/01/2016
28/01/2016 Centralised - Variation EMEA/H/C/3821/WS/766
Updated with Decision(2016)4933 of 22/07/2016
26/07/2016 PSUSA - Modification EMEA/H/C/3821/PSUSA/00010319/201510 (2016)4933 of 22/07/2016
06/09/2016 Centralised - 2-Monthly update EMEA/H/C/003821/II/0006 (2016)5726 of 02/09/2016
24/10/2016 Corrigendum (2016)5726 of 02/09/2016
10/11/2016 Centralised - Variation EMEA/H/C/003821/WS/0998
Updated with Decision(2017)111 of 09/01/2017
11/01/2017 PSUSA - Modification EMEA/H/C/003821/PSUSA/00010319/201604 (2017)111 of 09/01/2017