Pays: Canada
Langue: français
Source: Health Canada
Diacétate de gonadoréline tétrahydrique
BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.
50MCG
Solution
Diacétate de gonadoréline tétrahydrique 50MCG
Intramusculaire
10/30/50ML
Prescription
Bétails
Numéro de groupe d'ingrédients actifs (GIA) :0114053001
ANNULÉ APRÈS COMMERCIALISATION
2021-07-05
LOT EXP abcd ACTIVE INGREDIENT PER ML: 50 µg of gonadorelin diacetate tetrahydrate Administer I.M. 100 µg (2 mL) / cow SEE PACKAGE INSERT Store at or below 25°C DO NOT FREEZE Boehringer Ingelheim Animal Health Canada Inc. 5180 South Service Road Burlington ON L7L 5H4 INGRÉDIENT ACTIF PAR ML : 50 µg de diacétate de gonadoréline tétrahydrique Administrer par voie i.-m. 100 µg (2 mL) / vache VOIR LE DÉPLIANT Entreposer à une température égale ou inférieure à 25 °C NE PAS CONGELER Boehringer Ingelheim Santé Animale Canada Inc. 5180 South Service Road Burlington ON L7L 5H4 DIN 02172704 10 ML Veterinary use only Usage vétérinaire seulement Gonadorelin Sterile Solution Solution stérile de gonadoréline WARNINGS / MISES EN GARDE : See package insert for more information Voir le dépliant pour plus d'information 2020-1865-03 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 072 P XXX P XXX PACKAGING GRAPHIC ARTWORK APPROVAL CODE: 2020-1865-03 OLD CODE: 2020-1865-01 (02 not produced) DIMENSIONS: Please use the official PANTONE® (P) matching system for an accurate color representation. SPEC#: TBD VERSION PRODUCT: CYSTORELIN 10mL Label FOR SUBMISSION ONLY BAR CODE(S): N/A VERSION - DATE: A - 03/APR/2020 B - 12/MAY/2020 COUNTRY: CANADA (CA) NOTES SITE/SUPPLIER: HOSPIRA SOFTWARE: ADOBE CC ILPM / PHN / PR#: BI UPDATE INITIALS: Duluth (CW) COLORS MM = 73.025 X 25.4 mm INCHES = 2.875” x 1” _BY CATHERINE BARNES AT 12:46 PM, MAY 13, 2020_ _BY CATHERINE DUBOIS AT 11:40 AM, MAY 27, 2020_ _BY NORMAND PLOURDE AT 1:06 PM, MAY 27, 2020_ DATE SUBMITTED: MAY 28, 2020 (BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.) 2020-2974-03 ACTIVE INGREDIENT PER ML: 50 µg of gonadorelin diacetate tetrahydrate Administer I Lire le document complet