Zydelig

Medicinal product

(Invented) name

Zydelig

Active substance (s)

Idelalisibas

Strength

100 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EM01, idelalisib

Marketing authorisation holder

Gilead Sciences Ireland UC, Airija

Date of authorisation

2014-09-18

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

Film-coated tablet	1 vnt.
Idelalisibas	100 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
60219	74493	1074493	buteliukas	N60		Receptinis	EU/1/14/938/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-09-18	Registruotas