AMLODIPINE TABLETS

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

AMLODIPINE (AMLODIPINE BESYLATE)

Dostopno od:

NORA PHARMA INC

Koda artikla:

C08CA01

INN (mednarodno ime):

AMLODIPINE

Odmerek:

2.5MG

Farmacevtska oblika:

TABLET

Sestava:

AMLODIPINE (AMLODIPINE BESYLATE) 2.5MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

DIHYDROPYRIDINES

Povzetek izdelek:

Active ingredient group (AIG) number: 0131437003; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2022-07-25

Lastnosti izdelka

PRODUCT MONOGRAPH
PR
AMLODIPINE TABLETS
AMLODIPINE BESYLATE TABLETS HOUSE STD.
2.5 MG, 5 MG AND 10 MG AMLODIPINE (AS AMLODIPINE BESYLATE)
ANTIHYPERTENSIVE/ANTIANGINAL AGENT
NORA PHARMA INC.
40 Prince-Arthur, Suite 310
Saint-Lambert, Quebec
J4P 1X2
SUBMISSION CONTROL NO. 262285
Date
of
Revision:
April 7, 2022
Page 2 of 39
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
.....................................................................................
16
OVERDOSAGE
........................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
17
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 20
PART II: SCIENTIFIC
INFORMATION................................................................................
22
PHARMACEUTICAL INFORMATION
.................................................................................
22
DETAILED PHARMACOLOGY
......................................................