NTP-ZOPICLONE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ZOPICLONE

Saatavilla:

TEVA CANADA LIMITED

ATC-koodi:

N05CF01

INN (Kansainvälinen yleisnimi):

ZOPICLONE

Annos:

7.5MG

Lääkemuoto:

TABLET

Koostumus:

ZOPICLONE 7.5MG

Antoreitti:

ORAL

Kpl paketissa:

100/500

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0122562001; AHFS:

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2017-06-13

Valmisteyhteenveto

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_NTP-ZOPICLONE _
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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 _
_Page 2 of 38_
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
...........................................