ZOMIG TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
11-01-2023
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Werkstoffen:
ZOLMITRIPTAN
Beschikbaar vanaf:
XEDITON PHARMACEUTICALS INC
ATC-code:
N02CC03
INN (Algemene Internationale Benaming):
ZOLMITRIPTAN
Dosering:
2.5MG
farmaceutische vorm:
TABLET
Samenstelling:
ZOLMITRIPTAN 2.5MG
Toedieningsweg:
ORAL
Eenheden in pakket:
3/6
Prescription-type:
Prescription
Therapeutisch gebied:
SELECTIVE SEROTONIN AGONISTS
Product samenvatting:
Active ingredient group (AIG) number: 0134381001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2023-01-11
Productkenmerken
Page 1 of 47
PRODUCT MONOGRAPH
ZOMIG
®
zolmitriptan tablets
2.5 mg
ZOMIG RAPIMELT
®
zolmitriptan orally disintegrating tablets
2.5 mg
ZOMIG
® NASAL SPRAY
zolmitriptan nasal spray
2.5 and 5 mg
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Xediton Pharmaceuticals Inc.
2020 Winston Park Drive, Suite 402
Oakville, Ontario
L6H 6X7
www.xediton.com
Submission Control No.: 270277
ZOMIG
®
and ZOMIG RAPIMELT
®
are registered trademarks of Grünenthal GmbH, used under
license by Xediton Pharmaceuticals Inc.
Pr
Pr
Pr
Date of
Preparation:
JAN
9,
2023
Page 2 of 47
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
...............................................................................................
11
DRUG INTERACTIONS
...............................................................................................
19
DOSAGE AND ADMINISTRATION
...........................................................................
20
OVERDOSAGE
..............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 22
STORAGE AND STABILITY
.......................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 26
PART II: SCIENTIFIC INFORMATION
.............................................................................
27
PHARMACEUTICAL INFORMATION
...........................................
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