NORPROLAC TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

QUINAGOLIDE (QUINAGOLIDE HYDROCHLORIDE)

Dostępny od:

FERRING INC

Kod ATC:

G02CB04

INN (International Nazwa):

QUINAGOLIDE

Dawkowanie:

0.025MG

Forma farmaceutyczna:

TABLET

Skład:

QUINAGOLIDE (QUINAGOLIDE HYDROCHLORIDE) 0.025MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MISCELLANEOUS THERAPEUTIC AGENTS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2021-06-02

Charakterystyka produktu

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