RELPAX TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE)

Saatavilla:

BGP PHARMA ULC

ATC-koodi:

N02CC06

INN (Kansainvälinen yleisnimi):

ELETRIPTAN

Annos:

20MG

Lääkemuoto:

TABLET

Koostumus:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE) 20MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

SELECTIVE SEROTONIN AGONISTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0150241001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2004-08-05

Valmisteyhteenveto

PRODUCT MONOGRAPH
PR
RELPAX
®
(eletriptan hydrobromide tablets)
20 mg and 40 mg eletriptan/tablet
5-HT
1
Receptor Agonist
Migraine Therapy
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
AUG. 30, 2023
Submission Control No.: 278156
®
Viatris Specialty LLC
BGP Pharma ULC, a Viatris company, licensee
© BGP Pharma ULC, 2023
_ _
_RELPAX (eletriptan hydrobromide) – Product Monograph _
_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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................14
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
...........................................