NORPROLAC TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

QUINAGOLIDE (QUINAGOLIDE HYDROCHLORIDE)

Tilgjengelig fra:

FERRING INC

ATC-kode:

G02CB04

INN (International Name):

QUINAGOLIDE

Dosering :

0.05MG

Legemiddelform:

TABLET

Sammensetning:

QUINAGOLIDE (QUINAGOLIDE HYDROCHLORIDE) 0.05MG

Administreringsrute:

ORAL

Enheter i pakken:

30

Resept typen:

Prescription

Terapeutisk område:

MISCELLANEOUS THERAPEUTIC AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0150023002; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2021-06-02

Preparatomtale

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_NORPROLAC®_
_®_
_ Tablets _
_Page 1 of 26_
PRODUCT MONOGRAPH
NORPROLAC
®
quinagolide hydrochloride
Tablets 0.025 mg, 0.050 mg, 0.075 mg and 0.150 mg
ATC : G02CB04
Prolactin Inhibitor
FERRING INC.
200 YORKLAND BLVD.
SUITE # 800
TORONTO, ONTARIO
M2J 5C1
DATE OF REVISION :
OCTOBER 29, 2013
SUBMISSION CONTROL NO: 166779
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_NORPROLAC_
_®_
_ Tablets _
_Page 2 of 26_
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
................................................................................................
6
DRUG INTERACTIONS
................................................................................................
8
DOSAGE AND ADMINISTRATION
.............................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 9
STORAGE AND STABILITY
......................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 12
PART II: SCIENTIFIC INFORMATION
...............................................................................13
PHARMACEUTICAL
INFORMATION.......................................................................
13
CLINICAL
TRIALS......................................................................................................
14
DETAILED PHARMACOLOGY
.................................................................................
16
TOXICOLOGY
.......................................