Lenalidomide Accord

Medicinal product

(Invented) name

Lenalidomide Accord

Active substance (s)

Lenalidomidas

Strength

15 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)

L04AX04, Lenalidomide

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2018-09-20

Date of renewal

Documents

Lenalidomide Accord informuotumo apie rizika forma vyrams.pdf

Lenalidomide Accord mokomoji medziaga pacientui.pdf

Lenalidomide Accord mokomoji medziaga sveikatos prieziuros specialistams.pdf

Lenalidomide Accord paciento kortele.pdf

Lenalidomide Accord informuotumo apie rizika forma vaisingoms moterims.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Hard capsule	1 vnt.
Lenalidomidas	15 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
100244	86353	1086353	dalomoji lizdinė plokštelė	N7x1		Receptinis	EU/1/18/1316/008	Netiekiama	-	-	No	-	-
100245	86354	1086354	dalomoji lizdinė plokštelė	N21x1		Receptinis	EU/1/18/1316/009	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-09-20	Registruotas