AURO-ELETRIPTAN TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
26-07-2018
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Aktiv ingrediens:
ELETRIPTAN (ELETRIPTAN HYDROBROMIDE)
Tilgjengelig fra:
AURO PHARMA INC
ATC-kode:
N02CC06
INN (International Name):
ELETRIPTAN
Dosering :
40MG
Legemiddelform:
TABLET
Sammensetning:
ELETRIPTAN (ELETRIPTAN HYDROBROMIDE) 40MG
Administreringsrute:
ORAL
Enheter i pakken:
(1X6)/(2X3)/30/100
Resept typen:
Prescription
Terapeutisk område:
SELECTIVE SEROTONIN AGONISTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0150241002; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2018-07-26
Preparatomtale
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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
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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
.............................
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