Piqray

Medicinal product

(Invented) name

Piqray

Active substance (s)

Alpelisibas+Alpelisibas

Strength

50 mg + 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 (50 mg)	1 vnt.
Alpelisibas	50 mg
Film-coated tablet (200 mg)	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
104804	90905	1090905	lizdinė plokštelė	N28 (14×50 mg + 14×200 mg)		Receptinis	EU/1/20/1455/004	Netiekiama	-	-	No	-	-
104805	90906	1090906	lizdinė plokštelė	N56 (28×50 mg + 28×200 mg)		Receptinis	EU/1/20/1455/005	Netiekiama	-	-	No	-	-
104806	90907	1090907	lizdinė plokštelė	N168 (3×56) (3x28× 50 mg + 3×28×200 mg)		Receptinis	EU/1/20/1455/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-07-27	Registruotas