Piqray

Medicinal product

(Invented) name

Piqray

Active substance (s)

Alpelisibas

Strength

150 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	150 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
104798	90899	1090899	lizdinė plokštelė	N28		Receptinis	EU/1/20/1455/001	Netiekiama	-	-	No	-	-
104799	90900	1090900	lizdinė plokštelė	N56		Receptinis	EU/1/20/1455/002	Netiekiama	-	-	No	-	-
104803	90904	1090904	lizdinė plokštelė	N168 (3x56)		Receptinis	EU/1/20/1455/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-07-27	Registruotas