Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Vyndaqel   
Auth. number : EU/1/11/717
Active substance : tafamidis
Orphan market exclusivity for "Treatment of familial amyloid polyneuropathy" (based on designation EU/3/06/401) started on 18/11/2011
   10 years of market exclusivity
   This orphan market exclusivity will expire on 18/11/2021
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: N07XX08 - Tafamidis
(See WHO ATC Index)
Indication: Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy to delay peripheral neurologic impairment.
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, 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
17/11/2011 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2294 (2011)8520 of 16/11/2011
18/11/2011 Centralised - Authorisation EMEA/H/C/2294 (2011)8519 of 16/11/2011
04/07/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2294/T/1 (2012)4583 of 28/06/2012
25/04/2013 Centralised - Variation EMEA/H/C/2294/II/7
Updated with Decision(2014)3097 of 06/05/2014
25/07/2013 Centralised - Annual reassessment EMEA/H/C/2294/S/6
20/08/2013 Centralised - Variation EMEA/H/C/2294/IB/10
Updated with Decision(2014)3097 of 06/05/2014
20/03/2014 Centralised - Variation EMEA/H/C/2294/II/14
Updated with Decision(2014)3097 of 06/05/2014
08/05/2014 Centralised - Yearly update (2014)3097 of 06/05/2014
22/05/2014 Centralised - Variation EMEA/H/C/2294/IB/17
Updated with Decision(2015)3423 of 13/05/2015
27/05/2014 Centralised - Annual reassessment EMEA/H/C/2294/S/12
01/09/2014 Centralised - Variation EMEA/H/C/2294/IA/19
Updated with Decision(2015)3423 of 13/05/2015
25/09/2014 Centralised - Variation EMEA/H/C/2294/II/13
Updated with Decision(2015)3423 of 13/05/2015
15/01/2015 Centralised - Variation EMEA/H/C/2294/IB/24
Updated with Decision(2015)3423 of 13/05/2015
26/02/2015 Centralised - Variation EMEA/H/C/2294/II/21
Updated with Decision(2015)3423 of 13/05/2015
26/02/2015 Centralised - Annual reassessment EMEA/H/C/2294/S/22
20/05/2015 Centralised - Yearly update (2015)3423 of 13/05/2015
24/06/2015 Centralised - Notification EMEA/H/C/2294/N/26
Updated with Decision(2016)4916 of 22/07/2016
17/09/2015 Centralised - Variation EMEA/H/C/2294/II/27/G
Updated with Decision(2016)4916 of 22/07/2016
25/02/2016 Centralised - Annual reassessment EMEA/H/C/2294/S/31
26/07/2016 Centralised - Renewal EMEA/H/C/2294/R/32 (2016)4916 of 22/07/2016
07/09/2016 Centralised - Notification EMEA/H/C/2294/N/35
23/03/2017 Centralised - Annual reassessment EMEA/H/C/2294/S/36