Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Kalydeco   
Auth. number : EU/1/12/782
Active substance : ivacaftor
Orphan market exclusivity for "Treatment of cystic fibrosis" (based on designation EU/3/08/556) started on 25/07/2012
   10 years of market exclusivity
   This orphan market exclusivity will expire on 25/07/2022
ATC: Anatomical main group: R - Respiratory system
Therapeutic subgroup: R07 - Other respiratory system products
Pharmacological subgroup: R07A - Other respiratory system products
Chemical subgroup: R07AX - Other respiratory system products
Chemical substance: R07AX02 - Ivacaftor
(See WHO ATC Index)
Indication: Kalydeco tablets are indicated for the treatment of patients with cystic fibrosis (CF) aged 6 years and older who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R
Kalydeco is also indicated for the treatment of patients with cystic fibrosis (CF) aged 18 years and older who have an R117H mutation in the CFTR gene.
Marketing Authorisation Holder: Vertex Pharmaceuticals (Europe) Limited
2 Kingdom Street, London W2 6BD, 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
25/07/2012 Centralised - Authorisation EMEA/H/C/2494 (2012)5349 of 23/07/2012
25/02/2013 Centralised - Variation EMEA/H/C/2494/II/1
Updated with Decision(2013)8341 of 20/11/2013
30/05/2013 Centralised - Variation EMEA/H/C/2494/II/2
Updated with Decision(2013)8341 of 20/11/2013
22/11/2013 PSUSA - Modification EMEA/H/C/2494/PSU/12 (2013)8341 of 20/11/2013
02/12/2013 Centralised - Variation EMEA/H/C/2494/IB/11
Updated with Decision(2014)5502 of 28/07/2014
20/03/2014 Centralised - Variation EMEA/H/C/2494/II/14/G
Updated with Decision(2014)5502 of 28/07/2014
26/06/2014 Centralised - Variation EMEA/H/C/2494/II/13
Updated with Decision(2014)5502 of 28/07/2014
30/07/2014 Centralised - 2-Monthly update EMEA/H/C/2494/II/9 (2014)5502 of 28/07/2014
28/08/2014 Centralised - Notification EMEA/H/C/2494/N/28
Updated with Decision(2014)8884 of 19/11/2014
20/11/2014 Centralised - Variation EMEA/H/C/2494/II/30
Updated with Decision(2015)5985 of 20/08/2015
21/11/2014 PSUSA - Modification EMEA/H/C/2494/PSUV/21 (2014)8884 of 19/11/2014
18/12/2014 Centralised - Variation EMEA/H/C/2494/II/26
Updated with Decision(2015)5985 of 20/08/2015
23/04/2015 Centralised - Variation EMEA/H/C/2494/II/31
Updated with Decision(2015)5985 of 20/08/2015
23/04/2015 Centralised - Variation EMEA/H/C/2494/II/35
Updated with Decision(2015)5985 of 20/08/2015
27/08/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2494/T/40 (2015)5985 of 20/08/2015
19/11/2015 Centralised - Variation EMEA/H/C/2494/II/27, EMEA/H/C/2494/X/34/G (2015)8134 of 16/11/2015
01/02/2016 Centralised - Variation EMEA/H/C/2494/IB/43
Updated with Decision(2017) 1252 of 16/02/2017
13/10/2016 Centralised - Variation EMEA/H/C/2494/II/50
Updated with Decision(2017) 1252 of 16/02/2017
20/02/2017 Centralised - Yearly update (2017) 1252 of 16/02/2017
03/05/2017 Centralised - Renewal EMEA/H/C/2494/R/52 (2017) 2974 of 28/04/2017