País: Canadá
Idioma: inglés
Fuente: Health Canada
ZOLMITRIPTAN
VANC PHARMACEUTICALS INC
N02CC03
ZOLMITRIPTAN
2.5MG
TABLET (ORALLY DISINTEGRATING)
ZOLMITRIPTAN 2.5MG
ORAL
2X3
Prescription
SELECTIVE SEROTONIN AGONISTS
Active ingredient group (AIG) number: 0134381001; AHFS:
CANCELLED POST MARKET
2019-08-07
_VAN- Zolmitriptan ODT _ _Page 1 of 32_ PRODUCT MONOGRAPH PR VAN-ZOLMITRIPTAN ODT Zolmitriptan Orally Disintegrating Tablets 2.5 mg 5-HT 1 Receptor Agonist MIGRAINE THERAPY MANUFACTURER AND DISTRIBUTOR: DATE OF PREPARATION: MARCH 25, 2015 Vanc Pharmaceuticals Inc. Unit-210, 2639 Viking Way Richmond, BC V6V 3B7 www.vancpharm.com SUBMISSION CONTROL NO.: 182332 _VAN- Zolmitriptan ODT _ _Page 2 of 32_ 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.............................................................................. 16 OVERDOSAGE................................................................................................................. 17 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.......................................................................................................... 2 Leer el documento completo