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KAFTRIO
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1826232
Name of medicinal product:
KAFTRIO
Active substances:
Ivacaftor+Tezacaftor+Elexacaftor
Estonian
,
English
,
Latin
ATC code:
R07AX32
Dosage form:
film-coated tablet
Route of administration:
oral use
Strengh:
75mg+50mg+100mg
Amount in package:
56TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Kaftrio tablets are indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (see section 5.1).
Safety features:
Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL):
EST
Labelling:
Last imported to Estonia:
March 14, 2024
:
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions
to State Agency of Medicines
.
State Agency of Medicines
Marketing authorization
Marketing authorization holder:
Vertex Pharmaceuticals (Ireland) Limited
Marketing authorization number:
EU/1/20/1468
Marketing authorization issued on:
August 21, 2020
Marketing authorization expires on:
August 21, 2025
Marketing authorization procedure type:
Centralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: March 18, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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