LEGEND SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HYALURONATE SODIUM

Available from:

BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

HYALURONATE SODIUM 10MG

Administration route:

INTRA-ARTICULAR

Units in package:

2ML/4ML

Prescription type:

Prescription

Therapeutic group:

HORSES

Product summary:

Active ingredient group (AIG) number: 0115449001

Authorization status:

APPROVED

Authorization date:

2020-08-06

Patient Information leaflet

FOR INTRAVENOUS OR
INTRA-ARTICULAR USE IN HORSES ONLY.
Read package insert for details.
Pour plus d’information, consulter le feuillet de
renseignements.
BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC./
BOEHRINGER INGELHEIM SANTÉ ANIMALE CANADA INC.
5180 South Service Road, Burlington ON L7L 5H4
LEGEND
®
(hyaluronate sodium)
Sterile Injection 10 mg/mL
VETERINARY
USE ONLY
NET 2 ML
B3R1
2020-8687-01
86851504
(L) :
EXP:
DIN 02169541
2ML
4 Digit
Verification Code
Production Site
SAP Number
Please provide the regulatory required implementation
date for each country or country group providing approvals.
MARKETING approval:
COMPLETE NAME + DATE + SIGNATURE:
COMPLETE NAME + DATE + SIGNATURE:
REGULATORY approval:
LOCAL REGULATORY AUTH. IMPLEMENTATION REQUIREMENTS
COUNTRY
RA IMPLEMENTATION DEADLINE
COMMENTS/DIRECTIONS
P XXX
BLACK
P XXX
P XXX
P XXX
P 2587
(4C MATCH)
P XXX
P XXX
PACKAGING GRAPHIC ARTWORK APPROVAL
CODE: 2020-8687-01
OLD CODE: 2020-8687-00
DIMENSIONS:
Please use the official PANTONE® (P) matching
system for an accurate color representation.
SPEC#: 920-0302
VERSION
PRODUCT: LEGEND
2 mL VIAL LABEL
BAR CODE(S): Bayer SAP code: 86851504
4-Digit Code: B3R1
VERSION - DATE:
A - 09/SEP/2019
B - 02/MAR/2020
C - 12/MAY/2020
COUNTRY: CANADA (CA)
NOTES
SITE/SUPPLIER: BAYER
SOFTWARE: ADOBE CC
ILPM / PHN / PR#: BI UPDATE
INITIALS: Duluth (CW)
COLORS
MM =
INCHES = 2.46875” x 0.8125”
Labels are digitally printed 4C
_BY CATHERINE BARNES AT 2:26 PM, MAY 13, 2020_
_BY KRISTEN MILLEN AT 1:28 PM, JUN 16, 2020_
_BY NORMAND PLOURDE AT 1:56 PM, JUN 16, 2020_
DATE SUBMITTED: JUNE 19, 2020 (BOEHRINGER
INGELHEIM ANIMAL HEALTH CANADA INC.)
LEGEND
®
(hyaluronate sodium)
Sterile Injection 10 mg/mL
VETERINARY
USE ONLY
NET 4 ML
B2R5
2020-8688-01
86851431
DIN 02169541
FOR INTRAVENOUS USE
IN HORSES ONLY.
Read package insert for details.
Pour plus d’information, consulter le feuillet de
renseignements.
BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC./
BOEHRINGER INGELHEIM SANTÉ ANIMALE CANADA INC.
5180 South Service Road, Burlington O