APO-ELETRIPTAN TABLETS
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
13-07-2021
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Active ingredient:
ELETRIPTAN (ELETRIPTAN HYDROBROMIDE)
Available from:
APOTEX INC
ATC code:
N02CC06
INN (International Name):
ELETRIPTAN
Dosage:
40MG
Pharmaceutical form:
TABLET
Composition:
ELETRIPTAN (ELETRIPTAN HYDROBROMIDE) 40MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
SELECTIVE SEROTONIN AGONISTS
Product summary:
Active ingredient group (AIG) number: 0150241002; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-07-15
Summary of Product characteristics
IMPORTANT: PLEASE READ
Page 1 of 32
PRODUCT MONOGRAPH
Pr
APO-ELETRIPTAN TABLETS
Eletriptan Tablets
20 mg and 40 mg eletriptan (as eletriptan hydrobromide) tablets
5-HT
1
Receptor Agonist
Migraine Therapy APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9 SUBMISSION CONTROL NO.: 252302
Date of
Revision
July
13
,
2021
IMPORTANT: PLEASE READ
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
.................................................................................................
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
.........................................................................................................
21
DETAILED PHARMACOLO
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