EMPAVELI SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PEGCETACOPLAN

Available from:

SWEDISH ORPHAN BIOVITRUM AB (PUBL)

ATC code:

L04AJ03

INN (International Name):

PEGCETACOPLAN

Dosage:

1080MG

Pharmaceutical form:

SOLUTION

Composition:

PEGCETACOPLAN 1080MG

Administration route:

SUBCUTANEOUS

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0164341001; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-12-08

Summary of Product characteristics

_EMPAVELI™ _
_(pegcetacoplan injection) _
_Product Monograph _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
EMPAVELI™
Pegcetacoplan injection
Solution, 1080 mg / 20 mL (54 mg/mL) for subcutaneous infusion use
Selective immunosuppressants
Swedish Orphan Biovitrum AB (publ)
SE-112 76, Stockholm,
Sweden
Imported by:
C.R.I.
3544 North Service Road, Unit #400
Burlington, Ontario
L7N 3G2
Date of Initial Authorization:
DEC. 07, 2022
Submission Control Number: 263432
EMPAVELI™ is a trademark of Swedish Orphan Biovitrum AB (publ).
Copyright 2022 Swedish
Orphan Biovitrum (publ). All rights reserved.
_EMPAVELI™ (pegcetacoplan injection) _
_Product Monograph _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
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
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment......................................