Country: Canada
Language: English
Source: Health Canada
DACLIZUMAB BETA
BIOGEN CANADA INC
L04AC01
DACLIZUMAB
150MG
SOLUTION
DACLIZUMAB BETA 150MG
SUBCUTANEOUS
1ML
Prescription
Immunomodulatory Agents
Active ingredient group (AIG) number: 0158650001; AHFS:
CANCELLED PRE MARKET
2018-05-30
_ _ _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 Read the complete document