ROPINIROLE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE)

Available from:

COBALT PHARMACEUTICALS COMPANY

ATC code:

N04BC04

INN (International Name):

ROPINIROLE

Dosage:

2MG

Pharmaceutical form:

TABLET

Composition:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2MG

Administration route:

ORAL

Units in package:

21/100/500

Prescription type:

Prescription

Therapeutic area:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Product summary:

Active ingredient group (AIG) number: 0132618004; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2017-09-01

Summary of Product characteristics

_ _
_ROPINIROLE 0.25 mg, 1 mg, 2 mg & 5 mg Tablets _
_Page 1 of 52_
PRODUCT MONOGRAPH
Pr
ROPINIROLE
Ropinirole Tablets, USP
0.25 mg, 1 mg, 2 mg & 5 mg ropinirole (as ropinirole hydrochloride)
Antiparkinsonian Agent / Dopamine Agonist
Cobalt Pharmaceuticals Company
6733 Mississauga Road
Mississauga, Ontario
L5N 6J5
Date of Revision:
September 4, 2014
Submission Control No: 177073
_ _
_ROPINIROLE 0.25 mg, 1 mg, 2 mg & 5 mg Tablets _
_Page 2 of 52_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
20
DOSAGE AND ADMINISTRATION
.............................................................................
22
OVERDOSAGE
...............................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 24
STORAGE AND STABILITY
.........................................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 28
PART II: SCIENTIFIC INFORMATION
..............................................................................
29
PHARMACEUTICAL INFORMATION
.........................................................................
29
CLINICAL TRIALS
.....................................