TEVA-ZOLMITRIPTAN OD TABLET (ORALLY DISINTEGRATING)
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
06-04-2020
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Aktiv bestanddel:
ZOLMITRIPTAN
Tilgængelig fra:
TEVA CANADA LIMITED
ATC-kode:
N02CC03
INN (International Name):
ZOLMITRIPTAN
Dosering:
2.5MG
Lægemiddelform:
TABLET (ORALLY DISINTEGRATING)
Sammensætning:
ZOLMITRIPTAN 2.5MG
Indgivelsesvej:
ORAL
Enheder i pakken:
2/6
Recept type:
Prescription
Terapeutisk område:
SELECTIVE SEROTONIN AGONISTS
Produkt oversigt:
Active ingredient group (AIG) number: 0134381001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2011-06-07
Produktets egenskaber
PRODUCT MONOGRAPH
PR
TEVA-ZOLMITRIPTAN
(zolmitriptan) tablets
2.5 mg
PR
TEVA-ZOLMITRIPTAN OD
(zolmitriptan) orally disintegrating tablets
2.5 mg
Teva Standard
Migraine Therapy
5-HT
1
Receptor Agonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No: 237687
Date of Revision:
April 6, 2020
2
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
.........................................................................................................
12
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: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.................................................................................
25
CLINICAL TRIALS
...........................................
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