Orkambi

Medicinal product

(Invented) name

Orkambi

Active substance (s)

Lumakaftoras/Ivakaftoras

Strength

200 mg/125 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)

R07AX30, Ivacaftor and lumacaftor

Marketing authorisation holder

Vertex Pharmaceuticals (Ireland) Limited, Airija

Date of authorisation

2015-11-19

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.
Lumakaftoras	200 mg
Ivakaftoras	125 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
64635	79119	1079119	lizdinė plokštelė	N112 (4x28) (sudėtinė)		Receptinis	EU/1/15/1059/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-19	Registruotas