Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Firdapse   
Auth. number : EU/1/09/601
Active substance : amifampridine
Orphan market exclusivity for "Treatment of Lambert-Eaton myasthenic syndrome" (based on designation EU/3/02/124) started on 28/12/2009
   10 years of market exclusivity
   This orphan market exclusivity will expire on 28/12/2019
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: N07XX05 - Amifampridine
(See WHO ATC Index)
Indication: Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Marketing Authorisation Holder: BioMarin Europe Ltd.
10 Bloomsbury Way, London WC1A 2SL, 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
28/12/2009 Centralised - Authorisation EMEA/H/C/1032 (2009)10762 of 23/12/2009
28/01/2010 Centralised - Variation EMEA/H/C/1032/IA/1
Updated with Decision(2010)2499 of 15/04/2010
11/02/2010 Centralised - Notification EMEA/H/C/1032/N/2
Updated with Decision(2010)2499 of 15/04/2010
20/04/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1032/T/4 (2010)2499 of 15/04/2010
20/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1032/IA/5
10/09/2010 Centralised - Variation EMEA/H/C/1032/IA/6
Updated with Decision(2011)2693 of 12/04/2011
28/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1032/II/7/G
07/04/2011 Centralised - Variation EMEA/H/C/1032/IA/10
Updated with Decision(2011)8647 of 21/11/2011
14/04/2011 Centralised - Variation (2011)2693 of 12/04/2011
23/11/2011 Centralised - Annual reassessment EMEA/H/C/1032/S/9 (2011)8647 of 21/11/2011
03/08/2012 Centralised - Variation EMEA/H/C/1032/IB/19/G
Updated with Decision(2012)7903 of 29/10/2012
01/11/2012 Centralised - Variation (2012)7903 of 29/10/2012
15/03/2013 Centralised - Annual reassessment EMEA/H/C/1032/S/16 (2013)1647 of 13/03/2013
21/01/2014 Centralised - Annual reassessment EMEA/H/C/1032/S/22 (2014)318 of 16/01/2014
20/03/2014 Centralised - Variation EMEA/H/C/1032/II/26
Updated with Decision(2014)9271 of 28/11/2014
20/11/2014 Centralised - Annual reassessment EMEA/H/C/1032/S/27
02/12/2014 Centralised - Renewal EMEA/H/C/1032/R/29 (2014)9271 of 28/11/2014
05/02/2015 Centralised - Variation EMEA/H/C/1032/IA/35
24/09/2015 Centralised - Annual reassessment EMEA/H/C/1032/S/36
02/02/2016 Centralised - Variation EMEA/H/C/1032/WS/658