KIMMTRAK SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

TEBENTAFUSP

Dostępny od:

IMMUNOCORE IRELAND LIMITED

Kod ATC:

L01XX75

INN (International Nazwa):

TEBENTAFUSP

Dawkowanie:

100MCG

Forma farmaceutyczna:

SOLUTION

Skład:

TEBENTAFUSP 100MCG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Podsumowanie produktu:

Active ingredient group (AIG) number: 0163721001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2022-06-07

Charakterystyka produktu

_KIMMTRAK (tebentafusp) _
_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
KIMMTRAK
®
Tebentafusp
100 μg (mcg)/ 0.5 mL solution for intravenous infusion
Professed Standard
Antineoplastic agent
Immunocore Ireland Limited
Unit 1, Sky Business Centres,
Unit 21 Block Port Tunnel Business Park,
Clonshaugh
Dublin 17
Ireland
Date of Initial Authorization:
June 7, 2022
Imported and Distributed by:
Medison Pharma Canada Inc.
One Dundas Street West, Suite 2500
Toronto, Ontario
Canada, M5G 1Z3
Submission Control Number: 258717
_ _
_KIMMTRAK (tebentafusp) _
_Page 2 of 29_
RECENT MAJOR LABEL CHANGES
Not applicable.
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.................................................................................
4
4.1 Dosing Considerations
...........................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
........................................................ 5
4.3 Reconstitution
.....................................................................