NORPROLAC TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

QUINAGOLIDE (QUINAGOLIDE HYDROCHLORIDE)

Disponible des:

FERRING INC

Codi ATC:

G02CB04

Designació comuna internacional (DCI):

QUINAGOLIDE

Dosis:

0.025MG

formulario farmacéutico:

TABLET

Composición:

QUINAGOLIDE (QUINAGOLIDE HYDROCHLORIDE) 0.025MG

Vía de administración:

ORAL

Unidades en paquete:

30

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS THERAPEUTIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0150023001; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2021-06-02

Fitxa tècnica

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_NORPROLAC®_
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_ Tablets _
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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_
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_ 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
.......................................