Padcev

Medicinal product

(Invented) name

Padcev

Active substance (s)

Enfortumabas vedotinas

Strength

20 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FX13, enfortumab vedotin

Marketing authorisation holder

Astellas Pharma Europe B.V., Nyderlandai

Date of authorisation

2022-04-13

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

Powder for concentrate for solution for infusion	1 vnt.
Enfortumabas vedotinas	20 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
108514	94618	1094618	flakonas	N1		Receptinis	EU/1/21/1615/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-04-13	Registruotas