TEVA-ELETRIPTAN TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE)

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

N02CC06

INN (Διεθνής Όνομα):

ELETRIPTAN

Δοσολογία:

40MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE) 40MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

6

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

SELECTIVE SEROTONIN AGONISTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2013-04-12

Αρχείο Π.Χ.Π.

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