PADCEV POWDER FOR SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ENFORTUMAB VEDOTIN

Disponible des:

SEAGEN INC.

Codi ATC:

L01FX13

Designació comuna internacional (DCI):

ENFORTUMAB VEDOTIN

Dosis:

30MG

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

ENFORTUMAB VEDOTIN 30MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0163254002; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2021-10-29

Fitxa tècnica

_PADCEV_
_®_
_ (enfortumab vedotin) _
_Page 1 of 34_
27
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PADCEV®
enfortumab vedotin for injection
lyophilized powder for solution for intravenous infusion only
20 mg and 30 mg single-use vials
Antineoplastic Agent
Seagen Inc.
21823 30
th
Drive S.E.
Bothell, WA 98021
Canadian importer:
Seagen Canada Inc.
2000 Argentia Road, Plaza 3, Suite #400
Mississauga, ON L5N 1V9
Date of Initial Authorization:
October 29, 2021
Date of Revision:
July 7, 2023
Submission Control Number: 272213
PADCEV is a registered trademark of Seagen Inc., used under license
©Copyright 2021, Seagen Inc.
_PADCEV_
_®_
_ (enfortumab vedotin) _
_Page 2 of 34_
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment MM/YYYY
7 Warnings and Precautions MM/YYYY
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
...................................................................................