EPERZAN POWDER FOR SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

ALBIGLUTIDE

Saadav alates:

GLAXOSMITHKLINE INC

ATC kood:

A10BJ04

INN (Rahvusvaheline Nimetus):

ALBIGLUTIDE

Annus:

50MG

Ravimvorm:

POWDER FOR SOLUTION

Koostis:

ALBIGLUTIDE 50MG

Manustamisviis:

SUBCUTANEOUS

Ühikuid pakis:

1 PEN/ 4PENS

Retsepti tüüp:

Prescription

Terapeutiline ala:

MISCELLANEOUS ANTIDIABETIC AGENTS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0157070002; AHFS:

Volitamisolek:

CANCELLED PRE MARKET

Loa andmise kuupäev:

2017-10-24

Toote omadused

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_Page 1 of 66_
PRODUCT MONOGRAPH
Pr
EPERZAN™
albiglutide
Powder for Solution for Injection
in Pre-filled Pens
30 mg/0.5 mL and 50 mg/0.5 mL
(after reconstitution)
Antihyperglycemic Agent
Human Glucagon-Like Peptide-1 (GLP-1) receptor agonist
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Preparation:
February 12, 2016
DATE OF APPROVAL:
FEBRUARY 19, 2016
SUBMISSION CONTROL NO: 165145
_©_
_ 2016 GlaxoSmithKline Inc. All Rights Reserved _
_EPERZAN is a trademark of Glaxo Group Limited, used under license by
GlaxoSmithKline Inc. _
_ _
_Page 2 of 66_
TABLE OF CONTENTS PAGE
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
DESCRIPTION
..........................................................................................................
3
CONTRAINDICATIONS
...........................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................
5
ADVERSE REACTIONS
............................................................................................
8
DRUG INTERACTIONS
..........................................................................................
15
DOSAGE AND ADMINISTRATION
........................................................................
17
OVERDOSAGE
.......................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 19
STORAGE AND STABILITY
...................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
.................................................................. 24
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 25
PART II: SCIENTIFIC INFORMATION
................................