Gavreto

Medicinal product

(Invented) name

Gavreto

Active substance (s)

Pralsetinibas

Strength

100 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)

L01EX23, pralsetinib

Marketing authorisation holder

Blueprint Medicines (Netherlands) B.V., Nyderlandai

Date of authorisation

2021-11-18

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Hard capsule	1 vnt.
Pralsetinibas	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
107715	93820	1093820	buteliukas	N60		Receptinis	EU/1/21/1555/001	Netiekiama	-	-	No	-	-
107716	93821	1093821	buteliukas	N90		Receptinis	EU/1/21/1555/002	Netiekiama	-	-	No	-	-
107717	93822	1093822	buteliukas	N120		Receptinis	EU/1/21/1555/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-10-24	Išregistruotas
2021-11-18	Registruotas