ZINBRYTA SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

DACLIZUMAB BETA

Fáanlegur frá:

BIOGEN CANADA INC

ATC númer:

L04AC01

INN (Alþjóðlegt nafn):

DACLIZUMAB

Skammtar:

150MG

Lyfjaform:

SOLUTION

Samsetning:

DACLIZUMAB BETA 150MG

Stjórnsýsluleið:

SUBCUTANEOUS

Einingar í pakka:

1ML

Gerð lyfseðils:

Prescription

Lækningarsvæði:

Immunomodulatory Agents

Vörulýsing:

Active ingredient group (AIG) number: 0158650001; AHFS:

Leyfisstaða:

CANCELLED PRE MARKET

Leyfisdagur:

2018-05-30

Vara einkenni

_ _
_07 September 2018 _
_Page 1 of 55_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ZINBRYTA
™
Daclizumab beta
Solution for injection, 150 mg/mL
Immunomodulator
ZINBRYTA
TM SHOULD BE USED BY PHYSICIANS WHO HAVE SUFFICIENT KNOWLEDGE OF
MULTIPLE
SCLEROSIS AND WHO HAVE FAMILIARISED THEMSELVES WITH THE
EFFICACY/SAFETY PROFILE OF
ZINBRYTA
TM .
Biogen Canada Inc.
90 Burnhamthorpe Road West, Suite 1100
Mississauga, Ontario
L5B 3C3
Date of Initial Approval:
December 16, 2016
Date of Revision:
November 15, 2018
Submission Control No: 220549
_ _
_07 September 2018 _
_Page 2 of 55_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
SPECIAL HANDLING INSTRUCTIONS
.......................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC