Kalydeco

Medicinal product

(Invented) name

Kalydeco

Active substance (s)

Ivakaftoras

Strength

75 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)

R07AX02, Ivacaftor

Marketing authorisation holder

Vertex Pharmaceuticals (Ireland) Limited, Airija

Date of authorisation

2012-07-23

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.
Ivakaftoras	75 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
64777	79266	1079266	paketėlis	N56 (4×14)		Receptinis	EU/1/12/782/004	Netiekiama	-	-	No	-	-
111761	97876	1097876	paketėlis	N28 (4×7)		Receptinis	EU/1/12/782/009	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-07-23	Registruotas