Land: Canada
Språk: engelsk
Kilde: Health Canada
ELETRIPTAN (ELETRIPTAN HYDROBROMIDE)
AURO PHARMA INC
N02CC06
ELETRIPTAN
20MG
TABLET
ELETRIPTAN (ELETRIPTAN HYDROBROMIDE) 20MG
ORAL
(1X6)/(2X3)/30/100
Prescription
SELECTIVE SEROTONIN AGONISTS
Active ingredient group (AIG) number: 0150241001; AHFS:
APPROVED
2018-07-26
Page 1 of 32 PRODUCT MONOGRAPH Pr AURO-ELETRIPTAN 20 mg and 40 mg eletriptan (as eletriptan hydrobromide) tablets 5-HT 1 Receptor Agonist Migraine Therapy AURO PHARMA INC. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8, Canada Date of Preparation: July 26, 2018 SUBMISSION CONTROL NO: 201454 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 ................................................................................................. 14 DOSAGE AND ADMINISTRATION ............................................................................. 16 OVERDOSAGE ................................................................................................................ 17 ACTION AND CLINICAL PHARMACOLOGY............................................................ 17 STORAGE AND STABILITY ......................................................................................... 19 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 20 PART II: SCIENTIFIC INFORMATION ............................................................................... 21 PHARMACEUTICAL INFORMATION ......................................................................... 21 CLINICAL TRIALS ......................................................................................................... 21 DETAILED PHARMACOLOGY ............................. Les hele dokumentet