ROPINIROLE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE)

Dostępny od:

COBALT PHARMACEUTICALS COMPANY

Kod ATC:

N04BC04

INN (International Nazwa):

ROPINIROLE

Dawkowanie:

0.25MG

Forma farmaceutyczna:

TABLET

Skład:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.25MG

Droga podania:

ORAL

Sztuk w opakowaniu:

21/100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0132618001; AHFS:

Status autoryzacji:

CANCELLED PRE MARKET

Data autoryzacji:

2017-09-01

Charakterystyka produktu

_ _
_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
.....................................