MYLAN-ZOLMITRIPTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
06-06-2013
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Active ingredient:
ZOLMITRIPTAN
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
N02CC03
INN (International Name):
ZOLMITRIPTAN
Dosage:
2.5MG
Pharmaceutical form:
TABLET
Composition:
ZOLMITRIPTAN 2.5MG
Administration route:
ORAL
Units in package:
6
Prescription type:
Prescription
Therapeutic area:
SELECTIVE SEROTONIN AGONISTS
Product summary:
Active ingredient group (AIG) number: 0134381001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-07-12
Summary of Product characteristics
1
PRODUCT MONOGRAPH
PR
MYLAN-
Z
OLMITRIPTAN
Z
OLMITRIPTAN TABLETS 2.5 MG
5-HT
1 RECEPTOR AGONIST
MIGRAINE THERAPY
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke ON
M8Z 2S6
Date of Preparation: May 17, 2013
Submission Control No: 162242
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
.....................................................................................................
4
WARNINGS AND PRECAUTIONS
...................................................................................
4
ADVERSE REACTIONS
...................................................................................................
10
DRUG INTERACTIONS
....................................................................................................
17
DOSAGE AND ADMINISTRATION
...............................................................................
18
OVERDOSAGE
..................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 20
STORAGE AND STABILITY
...........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 22
PART II: SCIENTIFIC INFORMATION
.....................................................................
24
PHARMACEUTICAL INFORMATION
..............................................................................
24
CLINICAL TRIALS
...........................................................................................................
25
DETAILED PHARMACOLOGY
......................................................................................
27
TOXICOLOGY
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