NORPROLAC TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
31-10-2013
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Active ingredient:
QUINAGOLIDE (QUINAGOLIDE HYDROCHLORIDE)
Available from:
FERRING INC
ATC code:
G02CB04
INN (International Name):
QUINAGOLIDE
Dosage:
0.05MG
Pharmaceutical form:
TABLET
Composition:
QUINAGOLIDE (QUINAGOLIDE HYDROCHLORIDE) 0.05MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS THERAPEUTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0150023002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2021-06-02
Summary of Product characteristics
_ _
_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
_ _
_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
.......................................
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