Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Kalydeco   
Auth. number : EU/1/12/782
INN : ivacaftor
Orphan status based on designation EU/3/08/556 added on 25/07/2012
10 years of market exclusivity
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 is indicated for the treatment of cystic fibrosis (CF) in patients age 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.
Marketing Authorisation Holder: Vertex Pharmaceuticals (U.K.) Limited
Cardinal Point, Park Road, Rickmansworth, Herts WD3 1RE, 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 Centralised - 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
21/11/2014 Centralised - Modification EMEA/H/C/2494/PSUV/21 (2014)8884 of 19/11/2014
18/12/2014 Centralised - Variation EMEA/H/C/2494