TEVA-ZOLMITRIPTAN OD TABLET (ORALLY DISINTEGRATING)
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
08-08-2014
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Aktiv bestanddel:
ZOLMITRIPTAN
Tilgængelig fra:
TEVA CANADA LIMITED
ATC-kode:
N02CC03
INN (International Name):
ZOLMITRIPTAN
Dosering:
1MG
Lægemiddelform:
TABLET (ORALLY DISINTEGRATING)
Sammensætning:
ZOLMITRIPTAN 1MG
Indgivelsesvej:
ORAL
Enheder i pakken:
2/6
Recept type:
Prescription
Terapeutisk område:
SELECTIVE SEROTONIN AGONISTS
Produkt oversigt:
Active ingredient group (AIG) number: 0134381003; AHFS:
Autorisation status:
CANCELLED PRE MARKET
Autorisation dato:
2015-10-16
Produktets egenskaber
PRODUCT MONOGRAPH
PR
TEVA-ZOLMITRIPTAN
(zolmitriptan) tablets
1 mg and 2.5 mg
PR
TEVA-ZOLMITRIPTAN OD
(zolmitriptan) orally disintegrating tablets
1 mg and 2.5 mg
Professed Standard
Migraine Therapy
5-HT
1
Receptor Agonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No: 176520
Date of Revision:
July 31, 2014
2
TABLE OF CONTENTS
PRODUCT MONOGRAPH
........................................................................................................
1
TABLE OF CONTENTS
.............................................................................................................
2
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
.........................................................................................................
18
DOSAGE AND ADMINISTRATION
.....................................................................................
19
OVERDOSAGE
.......................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 21
STORAGE AND STABILITY
.................................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 24
PART II:
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