Cerdelga

Medicinal product

(Invented) name

Cerdelga

Active substance (s)

Eliglustatas

Strength

84 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)

A16AX10, Eliglustat

Marketing authorisation holder

Sanofi B.V., Nyderlandai

Date of authorisation

2015-01-19

Date of renewal

Documents

Cerdelga paciento kortele.pdf

Cerdelga mokomoji medziaga sveikatos prieziuros specialistams.pdf

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

Hard capsule	1 vnt.
Eliglustatas	84 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
61337	75655	1075655	lizdinė plokštelė	N56		Receptinis	EU/1/14/974/001	Netiekiama	-	-	No	-	-
61338	75656	1075656	lizdinė plokštelė	N196		Receptinis	EU/1/14/974/002	Netiekiama	-	-	No	-	-
65985	80499	1080499	lizdinė plokštelė	N14		Receptinis	EU/1/14/974/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-01-19	Registruotas