Symkevi

Medicinal product

(Invented) name

Symkevi

Active substance (s)

Tezakaftoras/Ivakaftoras

Strength

100 mg/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)

R07AX31, Ivacaftor and tezacaftor

Marketing authorisation holder

Vertex Pharmaceuticals (Ireland) Limited, Airija

Date of authorisation

2018-10-31

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.
Tezakaftoras	100 mg
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
100451	86559	1086559	lizdinė plokštelė	N28 (4x7)		Receptinis	EU/1/18/1306/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-10-31	Registruotas