Orkambi

Medicinal product

(Invented) name

Orkambi

Active substance (s)

Lumakaftoras/Ivakaftoras

Strength

100 mg/125 mg

Pharmaceutical form

granulės paketėlyje

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

Granules in sachet	1 vnt.
Lumakaftoras	100 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
100908	87019	1087019	paketėlis	N56 (4x14)		Receptinis	EU/1/15/1059/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-19	Registruotas