NOVO-WARFARIN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

WARFARIN SODIUM

Commercializzato da:

NOVOPHARM LIMITED

Codice ATC:

B01AA03

INN (Nome Internazionale):

WARFARIN

Dosaggio:

4MG

Forma farmaceutica:

TABLET

Composizione:

WARFARIN SODIUM 4MG

Via di somministrazione:

ORAL

Confezione:

100/250

Tipo di ricetta:

Prescription

Area terapeutica:

COUMARIN DERIVATIVES

Dettagli prodotto:

Active ingredient group (AIG) number: 0104597003; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2015-10-26

Scheda tecnica

PRODUCT MONOGRAPH
Pr
NOVO-WARFARIN
Warfarin Sodium
1mg, 2mg, 2.5mg, 3mg, 4mg, 5mg, 6mg, 7.5mg, 10mg Tablets
USP
Anticoagulant
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 097003
Date of Preparation:
February 18, 2005
_Page 2_
Table of Contents
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT
INFORMATION.........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS....................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE
REACTIONS....................................................................................................8
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................14
ACTION AND CLINICAL
PHARMACOLOGY.............................................................18
STORAGE AND STABILITY
..........................................................................................20
DOSAGE FORMS, COMPOSITION AND
PACKAGING..............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL
INFORMATION..........................................................................22
CLINICAL TRIALS
..........................................................................................................23
DETAILED PHARMACOLOGY
.....................................................................................26
TOXICOLOGY..................................................................................................................27
RE