TEVA-DABIGATRAN CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

Commercializzato da:

TEVA CANADA LIMITED

Codice ATC:

B01AE07

INN (Nome Internazionale):

DABIGATRAN ETEXILATE

Dosaggio:

75MG

Forma farmaceutica:

CAPSULE

Composizione:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 75MG

Via di somministrazione:

ORAL

Confezione:

30

Tipo di ricetta:

Prescription

Area terapeutica:

DIRECT THROMBIN INHIBITORS

Dettagli prodotto:

Active ingredient group (AIG) number: 0152467001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2018-02-19

Scheda tecnica

1
PRODUCT MONOGRAPH
PR
TEVA-DABIGATRAN
Dabigatran Etexilate
Capsule
s
Capsules 75 mg and 150 mg Dabigatran Etexilate,
(as Dabigatran Etexilate Me
silate)
Anticoagulant
Teva Canada Limited.
30 Novopharm Court,
Toronto, Ontario
M1B 2K9
Date of Preparation
APRIL 26, 2017
Control Number:
184807
2
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
.....................................................................................................
11
DRUG
INTERACTIONS.....................................................................................................
21
DOSAGE AND ADMINISTRATION
................................................................................
27
OVERDOSAGE
....................................................................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 34
STORAGE AND STABILITY
............................................................................................
38
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................. 38
PART II: SCIENTIFIC INFORMATION
....................................................................................
40
PHARMACEUTICAL INFORMATION
...........................................................................
40
CLINICAL
TRIALS.............................................................................................................
42
DETAILED PHARMACOLOGY
............