Authorization for Sale: Arepanrix^TM H1N1

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Authorization for Sale

Date:

October 21, 2009

Sponsor/Manufacturer:

ID Biomedical Corporation of Quebec
doing business as GlaxoSmithKline Biologicals North America
525 Cartier Blvd. West
Laval , Quebec
H7V 3S8

Submission Number:

132070

Product Name:

Arepanrix^TM H1N1

Medicinal Ingredient(s):

Split influenza virus, inactivated, containing antigen equivalent to
A/California/7/2009 (H1N1)v-like strain
Squalene, DL-a-tocopherol, Polysorbate 80

Therapeutic Classification:

active immunizing agent

Indication(s):

Active immunization against the H1N1 2009 influenza strain in an officially declared pandemic situation

Drug Identification Number(s), Route(s), Form, Strength:

02336650, IM, EML, 3.75 ug/0.5 ml

On behalf of the Minister of Health and pursuant to section 11 of the Interim Order Respecting the Authorization for Sale of the Vaccine for the Novel Influenza A H1N1 Virus, signed by the Minister on October 13, 2009, the product Arepanrix™ H1N1 (AS03-adjuvanted H1N1 pandemic influenza vaccine) is now authorized for sale in Canada.

Although Drug Identification Number 02336650 has been assigned to this product in accordance with the Interim Order you are exempted from the requirement to display this number on the product labelling.

Original signed by:
Elwyn Griffiths
Director General
Biologics and Genetic Therapies Directorate

Enclosures:
Drug Notification Form
CPID
Product Information Leaflet