NTP-ZOPICLONE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ZOPICLONE

Disponible des:

TEVA CANADA LIMITED

Codi ATC:

N05CF01

Designació comuna internacional (DCI):

ZOPICLONE

Dosis:

5MG

formulario farmacéutico:

TABLET

Composición:

ZOPICLONE 5MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Resumen del producto:

Active ingredient group (AIG) number: 0122562002; AHFS:

Estat d'Autorització:

CANCELLED PRE MARKET

Data d'autorització:

2017-06-13

Fitxa tècnica

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PRODUCT MONOGRAPH
Pr
NTP-ZOPICLONE
zopiclone
TABLETS, 3.75 MG, 5 MG AND 7.5 MG
HYPNOTIC AND SEDATIVE
Teva Canada Ltd.
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Preparation:
September 23, 2013
Submission Control No: 167612
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_NTP-ZOPICLONE _
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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
....................................................................................................8
DRUG INTERACTIONS
.....................................................................................................8
DOSAGE AND ADMINISTRATION
...............................................................................19
OVERDOSAGE
.................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
.............................................................11
STORAGE AND STABILITY
..........................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................................13
PART II: SCIENTIFIC
INFORMATION................................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
..........................................................................................................16
DETAILED PHARMACOLOGY
...........................................