ZOLMITRIPTAN TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ZOLMITRIPTAN

Disponibil de la:

PRO DOC LIMITEE

Codul ATC:

N02CC03

INN (nume internaţional):

ZOLMITRIPTAN

Dozare:

2.5MG

Forma farmaceutică:

TABLET

Compoziție:

ZOLMITRIPTAN 2.5MG

Calea de administrare:

ORAL

Unități în pachet:

6/30

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

SELECTIVE SEROTONIN AGONISTS

Rezumat produs:

Active ingredient group (AIG) number: 0134381001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2021-04-07

Caracteristicilor produsului

PRODUCT MONOGRAPH
PR
ZOLMITRIPTAN
Zolmitriptan Film-Coated Tablets, House Standard
2.5 mg
PR
ZOLMITRIPTAN ODT
Zolmitriptan Orally Dispersible Tablets, House Standard
2.5 mg
5-HT1 RECEPTOR AGONIST
MIGRAINE THERAPY
DATE OF REVISION:
MARCH 4, 2021
PRO DOC LTÉE
2925, boul. Industriel
Laval, Québec
H7L 3W9
Submission Control No.: 248801
Zolmitriptan
Zolmitriptan PM-E.pdf
Pg. 1
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_ZOLMITRIPTAN and ZOLMITRIPTAN ODT Product Monograph _
_Page 2 of 41 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
...............................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
5
ADVERSE REACTIONS
............................................................................................
12
DRUG INTERACTIONS
..............................................................................................
18
DOSAGE AND ADMINISTRATION
...........................................................................
20
OVERDOSAGE
............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 22
STORAGE AND STABILITY
......................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 25
PART II: SCIENTIFIC INFORMATION
............................................................................
26
PHARMACEUTICAL
INFORMATION.......................................................................
26
CLINICAL
TRIALS........................................................................