SANDOZ MIRTAZAPINE FC TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

MIRTAZAPINE

Pieejams no:

SANDOZ CANADA INCORPORATED

ATĶ kods:

N06AX11

SNN (starptautisko nepatentēto nosaukumu):

MIRTAZAPINE

Deva:

30MG

Zāļu forma:

TABLET

Kompozīcija:

MIRTAZAPINE 30MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

MISCELLANEOUS ANTIDEPRESSANTS

Produktu pārskats:

Active ingredient group (AIG) number: 0143928002; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2009-08-06

Produkta apraksts

_Page 1 of 32_
PRODUCT MONOGRAPH
Pr
RHOXAL-MIRTAZAPINE FC
15 and 30 mg tablets
Antidepressant
Rhoxalpharma Inc.
DATE OF PREPARATION:
4600 Thimens boulevard
April 19, 2005
Saint-Laurent, Quebec
H4R 2B2
DATE OF REVISION:
Control #: 098116
_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.................................................................................3
ADVERSE
REACTIONS...................................................................................................7
DRUG
INTERACTIONS..................................................................................................12
DOSAGE AND
ADMINISTRATION..............................................................................13
OVERDOSAGE................................................................................................................14
ACTION AND CLINICAL
PHARMACOLOGY............................................................15
STORAGE AND
STABILITY..........................................................................................18
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................18
PART II: SCIENTIFIC
INFORMATION................................................................................19
PHARMACEUTICAL
INFORMATION..........................................................................19
CLINICAL
TRIALS..........................................................................................................21
DETAILED
PHARMACOLOGY.....................................................................................22
TOXICOLOGY.......................