TEVA-ELETRIPTAN TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE)

Tilgjengelig fra:

TEVA CANADA LIMITED

ATC-kode:

N02CC06

INN (International Name):

ELETRIPTAN

Dosering :

40MG

Legemiddelform:

TABLET

Sammensetning:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE) 40MG

Administreringsrute:

ORAL

Enheter i pakken:

6

Resept typen:

Prescription

Terapeutisk område:

SELECTIVE SEROTONIN AGONISTS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2013-04-12

Preparatomtale

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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
............................