Alyftrek

Medicinal product

(Invented) name

Alyftrek

Active substance (s)

Deutivakaftoras/Tezakaftoras/Vanzakaftoras

Strength

125 mg/50 mg/10 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)

R07AX33, deutivacaftor, tezacaftor and vanzacaftor

Marketing authorisation holder

Vertex Pharmaceuticals (Ireland) Limited, Airija

Date of authorisation

2025-06-30

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

Tabletėje yra:	1 vnt.
Deutivakaftoras	125 mg
Tezakaftoras	50 mg
Vanzakaftoras	10 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
117915	104020	1104020	lizdinė plokštelė	N56		Receptinis	EU/1/25/1943/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-30	Registruotas