JAMP ELETRIPTAN TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE)

Disponible des:

JAMP PHARMA CORPORATION

Codi ATC:

N02CC06

Designació comuna internacional (DCI):

ELETRIPTAN

Dosis:

20MG

formulario farmacéutico:

TABLET

Composición:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE) 20MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

SELECTIVE SEROTONIN AGONISTS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2019-11-04

Fitxa tècnica

_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