Ivacaftor Teva

Medicinal product

(Invented) name

Ivacaftor Teva

Active substance (s)

Ivakaftoras

Strength

150 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)

R07AX02, Ivacaftor

Marketing authorisation holder

Teva B.V., Nyderlandai

Date of authorisation

2026-07-17

Date of renewal

Documents

6079_pakuotes lapelis_2026-07-17.docx

6079_Ivacaftor Teva.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HR/H/0330/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Ivakaftoras	150 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
121601	107711	1107711	lizdinė plokštelė	N28		Receptinis	LT/1/26/6079/001	Netiekiama	-	-	No	-	-
121602	107712	1107712	lizdinė plokštelė	N56		Receptinis	LT/1/26/6079/002	Netiekiama	-	-	No	-	-
121603	107713	1107713	dalomoji lizdinė plokštelė	N28×1		Receptinis	LT/1/26/6079/003	Netiekiama	-	-	No	-	-
121604	107714	1107714	dalomoji lizdinė plokštelė	N56×1		Receptinis	LT/1/26/6079/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-07-17	Registruotas