Страна: Канада
мова: англійська
Джерело: Health Canada
ZOLMITRIPTAN
TEVA CANADA LIMITED
N02CC03
ZOLMITRIPTAN
2.5MG
TABLET (ORALLY DISINTEGRATING)
ZOLMITRIPTAN 2.5MG
ORAL
2/6
Prescription
SELECTIVE SEROTONIN AGONISTS
Active ingredient group (AIG) number: 0134381001; AHFS:
APPROVED
2011-06-07
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 ........................................... Прочитайте повний документ