Riik: Kanada
keel: inglise
Allikas: Health Canada
ZOLMITRIPTAN
JUBILANT GENERICS LIMITED
N02CC03
ZOLMITRIPTAN
2.5MG
TABLET
ZOLMITRIPTAN 2.5MG
ORAL
6
Prescription
SELECTIVE SEROTONIN AGONISTS
Active ingredient group (AIG) number: 0134381001; AHFS:
APPROVED
2014-01-21
_Zolmitriptan _ _Page 1 of 31 _ PRODUCT MONOGRAPH PR ZOLMITRIPTAN Zolmitriptan Tablets, 2.5 mg 5-HT 1 Receptor Agonist MIGRAINE THERAPY SPONSOR: DATE OF REVISION: Jubilant Generics Limited March 27, 2020 1A- Sector 16A, Institutional Area, Noida, Uttar Pradesh, India, 201301 DISTRIBUTOR: Pharmapar Inc., 1565 Boul. Lionel- Boulet, Varennes QC J3X 1P7 SUBMISSION CONTROL NO.: 237077 _Zolmitriptan _ _Page 2 of 31 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION................................................... 3 SUMMARY PRODUCT INFORMATION..................................................................... 3 INDICATIONS AND CLINICAL USE............................................................................ 3 CONTRAINDICATIONS.................................................................................................. 3 WARNINGS AND PRECAUTIONS................................................................................ 4 ADVERSE REACTIONS.................................................................................................. 10 DRUG INTERACTIONS.................................................................................................. 15 DOSAGE AND ADMINISTRATION.............................................................................. 17 OVERDOSAGE................................................................................................................. 18 ACTION AND CLINICAL PHARMACOLOGY............................................................. 18 STORAGE AND STABILITY.......................................................................................... 20 DOSAGE FORMS, COMPOSITION AND PACKAGING............................................. 20 PART II: SCIENTIFIC INFORMATION.............................................................................. 21 PHARMACEUTICAL INFORMATION.......................................................................... 21 CLINICAL TRIALS....................................................................................... Lugege kogu dokumenti