Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Tecfidera   
Auth. number : EU/1/13/837
Active substance : Dimethyl fumarate
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N07 - Other nervous system drugs
Pharmacological subgroup: N07X - Other nervous system drugs
Chemical subgroup: N07XX - Other nervous system drugs
Chemical substance: N07XX09 - Dimethyl fumarate
(See WHO ATC Index)
Indication: Tecfidera is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (please refer to section 5.1 for important information on the populations for which efficacy has been established).
Marketing Authorisation Holder: Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom
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
03/02/2014 Centralised - Authorisation EMEA/H/C/2601 (2014)601 of 30/01/2014
10/04/2014 Centralised - Variation EMEA/H/C/2601/IB/2/G
Updated with Decision(2015)2531 of 13/04/2015
28/10/2014 Centralised - Variation EMEA/H/C/2601/IB/8
Updated with Decision(2015)2531 of 13/04/2015
15/04/2015 Centralised - Yearly update (2015)2531 of 13/04/2015
17/06/2015 Centralised - Variation EMEA/H/C/2601/IA/15
Updated with Decision(2015)9628 of 16/12/2015
22/07/2015 Centralised - Variation EMEA/H/C/2601/IB/18
Updated with Decision(2015)9628 of 16/12/2015
22/12/2015 Centralised - 2-Monthly update EMEA/H/C/2601/WS/689/G (2015)9628 of 16/12/2015
18/05/2016 Centralised - Variation EMEA/H/C/2601/IB/31
02/06/2016 Centralised - Variation EMEA/H/C/2601/II/29
14/07/2016 Centralised - Variation EMEA/H/C/002601/II/0028
28/07/2016 Centralised - Variation EMEA/H/C/002601/II/30
17/11/2016 Centralised - Variation EMEA/H/C/002601/II/34