JAMP ELETRIPTAN TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE)

Fáanlegur frá:

JAMP PHARMA CORPORATION

ATC númer:

N02CC06

INN (Alþjóðlegt nafn):

ELETRIPTAN

Skammtar:

40MG

Lyfjaform:

TABLET

Samsetning:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE) 40MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Lækningarsvæði:

SELECTIVE SEROTONIN AGONISTS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2019-11-04

Vara einkenni

_JAMP ELETRIPTAN (eletriptan hydrobromide) - Product Monograph_
_Page 1 of 33_
PRODUCT MONOGRAPH
Pr
JAMP ELETRIPTAN
Eletriptan Hydrobromide Tablets
20 mg and 40 mg eletriptan (as eletriptan hydrobromide)
5-HT
1
Receptor Agonist
Migraine Therapy
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
Canada, J4B 5H3
Date
of
Preparation:
November 1, 2019
SUBMISSION CONTROL NO: 222365
_JAMP ELETRIPTAN (eletriptan hydrobromide) - Product Monograph_
_Page 2 of 33_
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