Piqray

Medicinal product

(Invented) name

Piqray

Active substance (s)

Alpelisibas

Strength

200 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)

L01EM03, alpelisib

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2020-07-27

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.
Alpelisibas	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
104807	90908	1090908	lizdinė plokštelė	N14		Receptinis	EU/1/20/1455/007	Netiekiama	-	-	No	-	-
104808	90909	1090909	lizdinė plokštelė	N28		Receptinis	EU/1/20/1455/008	Netiekiama	-	-	No	-	-
104809	90910	1090910	lizdinė plokštelė	N84 (3×28)		Receptinis	EU/1/20/1455/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-07-27	Registruotas