BIO-SITAGLIPTIN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE)

Commercializzato da:

BIOMED PHARMA

Codice ATC:

A10BH01

INN (Nome Internazionale):

SITAGLIPTIN

Dosaggio:

50MG

Forma farmaceutica:

TABLET

Composizione:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE) 50MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Dettagli prodotto:

Active ingredient group (AIG) number: 0152414003; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2023-11-16

Scheda tecnica

_ _
_Product Monograph - Bio-SITAGLIPTIN _
_Page 1 of 57_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BIO-SITAGLIPTIN
sitagliptin tablets
Tablets, 25, 50 and 100 mg sitagliptin (as sitagliptin phosphate
anhydrous), Oral
House Standard
ATC Code: A10BH01
Dipeptidyl peptidase 4 (DPP-4) inhibitors
Submission Control Number:
280289
Biomed Pharma
1B-9450 Boulevard Langelier
Montreal, Quebec
H1P3H8, Canada
Date of
Initial
Authorization:
NOV 16, 2023
_Product Monograph - Bio-SITAGLIPTIN Page _2_ of _57
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4

Pediatrics (<18 years of age): Based on the data submitted and
reviewed by Health
Canada, the safety and efficacy of sitagliptin in pediatric patients
has not been
established; therefore, Health Canada has not authorized an indication
for pediatric
use.
......................................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
..............................................................................................
4
4.2
Recommended Dose and Dosage Adju