TEVA-REPAGLINIDE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

REPAGLINIDE

Commercializzato da:

TEVA CANADA LIMITED

Codice ATC:

A10BX02

INN (Nome Internazionale):

REPAGLINIDE

Dosaggio:

1MG

Forma farmaceutica:

TABLET

Composizione:

REPAGLINIDE 1MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

MEGLITINIDES

Dettagli prodotto:

Active ingredient group (AIG) number: 0137035002; AHFS:

Stato dell'autorizzazione:

CANCELLED PRE MARKET

Data dell'autorizzazione:

2021-07-29

Scheda tecnica

PRODUCT MONOGRAPH
PR
TEVA-REPAGLINIDE
(repaglinide)
0.5 mg, 1 mg and 2 mg tablets
Teva Standard
Oral Antidiabetic Agent
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
March 31, 2011
Toronto, Ontario
M1B 2K9
Control # 133231
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
INDICATIONS AND CLINICAL
USE.......................................................................
3
CONTRAINDICATIONS
............................................................................................
4
WARNINGS AND
PRECAUTIONS...........................................................................
4
ADVERSE
REACTIONS.............................................................................................
7
DRUG INTERACTIONS
...........................................................................................
10
DOSAGE AND
ADMINISTRATION.......................................................................
14
OVERDOSAGE
.........................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
..................................................... 15
STORAGE AND
STABILITY...................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................... 18
PART II: SCIENTIFIC INFORMATION
...............................................................................
20
PHARMACEUTICAL
INFORMATION...................................................................
20
CLINICAL
TRIALS.................................................................................................
201
DETAILED
PHARMACOLOGY..............................................................................
24
TOXICOLOGY
..........................................................................................................
27
REFERENCES
.....................................................................................