Odomzo

Medicinal product

(Invented) name

Odomzo

Active substance (s)

Sonidegibas

Strength

200 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XJ02, sonidegib

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B. V., Nyderlandai

Date of authorisation

2015-08-14

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

Capsule, hard	1 vnt.
Sonidegibas	200 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
63441	77881	1077881	lizdinė plokštelė	N10x1		Receptinis	EU/1/15/1030/001	Netiekiama	-	-	No	-	-
63444	77884	1077884	lizdinė plokštelė	N30x1		Receptinis	EU/1/15/1030/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-08-14	Registruotas