Kaftrio

Medicinal product

(Invented) name

Kaftrio

Active substance (s)

Ivakaftoras/Tezakaftoras/Eleksakaftoras

Strength

37,5 mg/25 mg/50 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R07AX32, ivacaftor, tezacaftor and elexacaftor

Marketing authorisation holder

Vertex Pharmaceuticals (Ireland) Limited, Airija

Date of authorisation

2020-08-21

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Ivakaftoras	37,5 mg
Tezakaftoras	25 mg
Eleksakaftoras	50 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
107836	93941	1093941	lizdinė plokštelė	N56 (4×14)		Receptinis	EU/1/20/1468/002	Netiekiama	2024-10-10	-	Yes	2025-01-03	2025-12-31

Stadijos

Data	Stadija
2020-08-21	Registruotas