ZOLMITRIPTAN-ODT TABLET (ORALLY DISINTEGRATING)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ZOLMITRIPTAN

Διαθέσιμο από:

JUBILANT GENERICS LIMITED

Φαρμακολογική κατηγορία (ATC):

N02CC03

INN (Διεθνής Όνομα):

ZOLMITRIPTAN

Δοσολογία:

2.5MG

Φαρμακοτεχνική μορφή:

TABLET (ORALLY DISINTEGRATING)

Σύνθεση:

ZOLMITRIPTAN 2.5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

6

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

SELECTIVE SEROTONIN AGONISTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2014-01-20

Αρχείο Π.Χ.Π.

_ZOLMITRIPTAN-ODT _
_Page 1 of 31 _
PRODUCT MONOGRAPH
PR
ZOLMITRIPTAN-ODT
Zolmitriptan Orally Disintegrating Tablets
2.5 mg
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
SPONSOR: DATE OF REVISION:
Jubilant Generics Limited
April 1, 2020
1A- Sector 16A, Institutional Area,
Noida, Uttar Pradesh, India, 201301
DISTRIBUTOR:
Pharmapar Inc.,
1565 Boul. Lionel- Boulet, Varennes QC
J3X 1P7
SUBMISSION CONTROL NO.: 237423
_ZOLMITRIPTAN-ODT _
_Page 2 of 31 _
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..................................................................................................
15
DOSAGE AND
ADMINISTRATION..............................................................................
17
OVERDOSAGE.................................................................................................................
18
ACTION AND CLINICAL
PHARMACOLOGY.............................................................
18
STORAGE AND
STABILITY..........................................................................................
20
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 20
PART II: SCIENTIFIC
INFORMATION.........................................................................
21
PHARMACEUTICAL
INFORMATION..........................................................................
21
CLINICAL
TRIALS..............................................................