ROPINIROLE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE)

제공처:

COBALT PHARMACEUTICALS COMPANY

ATC 코드:

N04BC04

INN (국제 이름):

ROPINIROLE

복용량:

2MG

약제 형태:

TABLET

구성:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2MG

관리 경로:

ORAL

패키지 단위:

21/100/500

처방전 유형:

Prescription

치료 영역:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

제품 요약:

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

승인 상태:

CANCELLED PRE MARKET

승인 날짜:

2017-09-01

제품 특성 요약

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