TEVA-ELETRIPTAN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE)

Saatavilla:

TEVA CANADA LIMITED

ATC-koodi:

N02CC06

INN (Kansainvälinen yleisnimi):

ELETRIPTAN

Annos:

40MG

Lääkemuoto:

TABLET

Koostumus:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE) 40MG

Antoreitti:

ORAL

Kpl paketissa:

6

Prescription tyyppi:

Prescription

Terapeuttinen alue:

SELECTIVE SEROTONIN AGONISTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0150241002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2013-04-12

Valmisteyhteenveto

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PRODUCT MONOGRAPH
PR
TEVA-ELETRIPTAN
eletriptan hydrobromide
Tablets 20 mg and 40 mg eletriptan (as eletriptan hydrobromide)
5-HT
1
Receptor Agonist
Migraine Therapy
Teva Canada Limited
30 Novopharm Limited
Toronto, Ontario
M1B 2K9
Date of Revision
October 20, 2014
Submission Control No: 178627
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_Page 2 of 34_
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
.......................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 18
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.................................................................................
22
CLINICAL TRIALS
............................