AMLODIPINE BESYLATE TABLETS, 5MG

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

AMLODIPINE (AMLODIPINE BESYLATE)

Dostopno od:

DR. REDDY'S LABORATORIES INC

Koda artikla:

C08CA01

INN (mednarodno ime):

AMLODIPINE

Odmerek:

5MG

Farmacevtska oblika:

TABLET

Sestava:

AMLODIPINE (AMLODIPINE BESYLATE) 5MG

Pot uporabe:

ORAL

Enote v paketu:

90/100/200/300/500

Tip zastaranja:

Prescription

Terapevtsko območje:

DIHYDROPYRIDINES

Povzetek izdelek:

Active ingredient group (AIG) number: 0131437002; AHFS:

Status dovoljenje:

CANCELLED PRE MARKET

Datum dovoljenje:

2023-06-27

Lastnosti izdelka

Page 1 of 33
PRODUCT MONOGRAPH
PR
AMLODIPINE BESYLATE TABLETS
5 mg and 10 mg amlodipine as amlodipine besylate
Antihypertensive-Antianginal
Agent
MANUFACTURED BY:
Date of Initial Approval:
DR. REDDY’S LABORATORIES INC.
December 14, 2009
107 College Road East, Princeton
New Jersey, 08540
Date of Revision:
USA
October 24, 2022
IMPORTED AND DISTRIBUTED BY:
DR. REDDY’S LABORATORIES CANADA INC.
5580 Explorer Drive, Suite 204
Mississauga, ON L4W 4Y1
Canada
SUBMISSION CONTROL NO: 264381
Page 2 of 33
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL
USE..........................................................................
3
CONTRAINDICATIONS
..............................................................................................
4
WARNINGS AND
PRECAUTIONS
...............................................................................
4
ADVERSE REACTIONS
..............................................................................................
6
DRUG INTERACTIONS
..............................................................................................
9
DOSAGE AND
ADMINISTRATION..........................................................................
14
OVERDOSAGE
..........................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 16
STORAGE AND
STABILITY.....................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 19
PART II: SCIENTIFIC
INFORMATI ON ...........................................................................
20
PHARMACEUTICAL
INFORMATION
.......................................................................
20
DETAILED PHARMACOLOGY
.........................