Archive 1. List of drugs for exceptional importation and sale [2022-09-27]

Drugs included on the list for exceptional importation and sale are called "designated drugs". They are eligible for exceptional importation and sale as per sections C.10.004 to C.10.011 of the Food and Drug Regulations. This list is incorporated by reference in these regulations. Health Canada maintains and updates this list as required.

Designated drugs are eligible for exceptional importation into Canada before the date listed in the "Date importation no longer allowed" column. Products cannot be exceptionally imported after this date, but products already imported may be sold until their expiry dates.

For more information on the exceptional importation and sale of drugs, please consult the following:

Supercedes: 2022-08-18

Date issued: 2022-09-01

Access the archived versions of this list associated to the Food and Drug Regulations.

Before these regulations were in force, similar provisions existed under the Second Interim Order respecting drugs, medical devices and foods for a special dietary purpose in relation to COVID-19. Consult the list of drugs (now archived) that were authorized for exceptional importation under the IO no. 2.

List of Drugs for Exceptional Importation and Sale
Brand name of drug, medicinal ingredient(s) Dosage form, strength, route(s) of administration Country of authorization, name of foreign regulatory authority, identifying code or number Name of importing licensee Lot number and quantities Date product added to this list Date after which drug may no longer be imported Information to support safe use made available by importer
0.9% Sodium Chloride Injection USP, Sodium Chloride Solution, 900 MG / 100 ML, Intravenous United States, Food and Drug Administration, National Drug Code (NDC): 0338-0049-04 Baxter Corporation N/A August 31, 2022 March 31, 2023 Contact Baxter Corporation at:
7125 Mississauga Rd.,
Mississauga, ON,
L5N 0C2
Telephone: 1-888-719-9955
Fax: 1-905-369-6560
Cortef, Hydrocortisone Tablet, 10 mg, Oral United States, Food and Drug Administration, National Drug Code (NDC) 0009-0031-01 Pfizer Canada ULC N/A May 18, 2022 August 19, 2022 Contact Pfizer Canada at:
7300 Trans-Canada Hwy.,
Kirkland, QC
H9J 2M5
Telephone: 1-866-723-7111
Fax: 1-855-242-5652
PrismaSATE BGK4/0/1.2, Multiple Medical Ingredients (CRRT) Solution, Dialysis, Intravenous Use United States, Food and Drug Administration License Number K072908
Product Code: 110411
Baxter Corporation N/A July 12, 2021 June 30, 2022 CContact Baxter Corporation at: 7125 Mississauga Rd.,
Mississauga, ON,
L5N 0C2
Telephone: 1-888-719-9955
Fax: 1-905-369-6560
Prostin VR Pediatric, Alprostadil Sterile Solution, 500 mcg/mL, intravenous infusion United States, Food and Drug Administration, NDC 00009-3169-06 Pfizer Canada ULC N/A March 7, 2022 April 29, 2022 Contact Pfizer Canada at:
17300 Trans-Canada Hwy.,
Kirkland, QC
H9J 2M5
Telephone: 1-866-723-7111
Fax: 1-855-242-5652
Depo-Provera,
Medroxyprogesterone Acetate
Suspension for Injection, 150 mg/mL,
Intramuscular
United States, Food and Drug Administration
National Drug Code (NDC) 0009-7376-11
Pfizer Canada ULC N/A March 31, 2021 July 20, 2022 Contact Pfizer Canada at:
17300 Trans-Canada Hwy.,
Kirkland, QC
H9J 2M5
Telephone: 1-866-723-7111
Fax: 1-855-242-5652
Propofol Injectable Emulsion, USP, Propofol Emulsion,
1000 mg per 100 mL (10 mg/mL),
Intravenous
United States, Food and Drug Administration
NDC 25021-608-51
Omega Laboratories Limited N/A April 28, 2021 March 2, 2022 Contact Omega Laboratories Limited at:
11177 Hamon Street
Montreal, Quebec
Canada, H3M 3E4
Diprivan 10mg/mL,
Propofol
Emulsion,
10mg/mL,
Intravenous use
Italy, Agenzia Italiana del Farmaco
026114025
Aspen Pharmacare Inc. N/A September 18, 2020 March 2, 2022 Contact Aspen Pharmacare Canada Inc. at:
8 - 1155 North Service Road West,
Oakville, Ontario
L6M 3E3
Telephone: 1-844-330-1213
Erwinase, Erwinia L-asparaginase Powder for solution, 10,000 IU,
Subcutaneous, Intravenous, Intramuscular
United Kingdom, Medicines and Healthcare products Regulatory Agency,
PL44403/0002
SteriMax Inc. W060172,
W060517,
W061186, W061933, W062155
April 4, 2022 September 30, 2022 SteriMax Inc.,
2770, Portland Drive, Oakville, ON, L6H 6R4
Phone: +1-800-881-3550
Fax: +1 -877-546-7667
E-mail: medinfo@sterimaxinc.com
Hydralazine Hydrochloride Injection USP, Hydralazine Sterile Solution, 20mg/mL, Intravenous, Intramuscular United States, Food and Drug Administration, National Drug Code (NDC) 0517-0901-25 SteriMax Inc. N/A July 11, 2022 November 1, 2022

SteriMax Inc.,
2770, Portland Drive, Oakville, ON, L6H 6R4
Phone: +1-800-881-3550
Fax: +1 -877-546-7667

E-mail: medinfo@sterimaxinc.com
Levofloxacin Injection in 5% Dextrose, levofloxacin Injectable Solution, 5 mg/mL, intravenous infusion United States, Food and Drug Administration, NDCs:
0143-9722-24 (50 mL)
0143-9721-24 (100 mL)
0143-9720-24 (150 mL)
Hikma Canada Limited N/A April 11, 2022 July 29, 2022 Contact Hikma Canada Limited at:
5995 Avebury Road, Suite 804
Mississauga, ON
Canada L5R 3P9
Phone: 1-800-656-0793
Disoprivan 1%,
Propofol
Solution,
500mg/50mL (1%),
Intravenous use
Switzerland, Swiss Medic,
47162 076
Aspen Pharmacare Canada Inc. N/A July 23, 2020 March 2, 2022 Contact Aspen Pharmacare Canada Inc. at:
8 - 1155 North Service Road West,
Oakville, Ontario
L6M 3E3
Telephone: 1-844-330-1213
Fresenius Propoven, Propofol Emulsion for injection or infusion,
100mL vial - 20mg/mL (2%), Intravenous use
Austria and Sweden, Inner vial label: M080395
Outer box label: M080396
Package leaflet: M080510
Fresenius Kabi Canada Ltd. N/A April 16, 2020 March 2, 2022 Dear Healthcare Professional Letter
Propylthiouracil 50mg Tablets;
Propylthiouracil
Tablet,
50mg,
Oral use
United Kingdom, Medicines and Healthcare Products Regulatory Agency,
PL 00042/0205
PA 1888-2-1
Accelera Pharma Canada
61096F
August 21, 2020 June 1, 2022 Contact Accelera Pharma Canada at:
210B-219 Dufferin Street
Toronto, ON
M6K 3J1
Telephone: 1-289-208-4191
PTU™,
Propylthiouracil
Tablet,
50mg,
Oral use
Australia, Therapeutic Goods Administration,
AUST R 13313
Phebra Canada Inc. Lot: 801460, 848726, 883345, 876591, 889241, 897976 June 18, 2020 June 1, 2022 Company Communications for Healthcare Professionals
TECHNETIUM TC 99M TSC,
Sodium Thiosulfate Pentahydrate
Powder for Solution, Kit, 2mg/vial, Oral,
Intravenous, Intraperitoneal
United States, Food and Drug Administration, National
Drug Code (NDC): 45567-0030-1
GE Healthcare Canada Inc. N/A July 13, 2022 August 12, 2022 Contact GE Healthcare Canada Inc. at: 1919 Minnesota Court
Mississauga, ON, Canada
L5N 0C9,
Phone: 866-281-7545
TPOXX , tecovirimat Capsule, 200 mg, Oral United States,
Food and Drug
Administration,
National Drug
Code (NDC) 50072-200-42
Innomar Strategies Inc. N/A July 25, 2022 December 31, 2022 Contact SIGA Technologies, Inc. at 1-888-899-3472
Omnipaque 350, Iohexol Solution, 755 mg/mL, IBP - intravenous, PBP- intravascular,oral, intra-arterial United States, Food and Drug Administration, National Drug Code (NDC):
0407-1414-72 and 0407-1414-98
GE Healthcare Canada Inc. N/A August 22, 2022 February 22, 2023 Contact GE Healthcare Canada Inc. at: 1919 Minnesota Court
Mississauga, ON, Canada
L5N 0C9
Telephone: 866-281-7545
Visipaque 320, Iodixanol Solution, 652mg/mL, intra-arterial, intravenous United States, Food and Drug Administration, National Drug Code (NDC):
0407-2223-17
GE Healthcare Canada Inc. N/A August 22, 2022 February 22, 2023 Contact GE Healthcare Canada Inc. at: 1919 Minnesota Court
Mississauga, ON, Canada
L5N 0C9
Telephone: 866-281-7545
0.9% Sodium Chloride Injection, USP,
Sodium Chloride
Solution,
9mg/mL,
Intravenous, Intramuscular or Subcutaneous use
United States, Food and Drug Administration
National Drug Code (NDC): 00409-4888-10
Pfizer Canada ULC N/A January 28,2022 March 2, 2022 Contact Pfizer Canada at:
17300 Trans-Canada Hwy.,
Kirkland, QC
H9J 2M5
Telephone: 1-866-723-7111
Fax: 1-855-242-5652
Actemra, Tocilizumab Solution, 80 mg/4 mL,
Intravenous Use

Canadian Actemra (Health Canada, DIN: 02350092)
in global EFA packaging and labelling (Global Trade Item Number: 07640128015161)

Hoffmann-La Roche N/A February 22, 2021 June 1, 2022 Contact Hoffmann-La Roche at:
7070 Mississauga Road
Mississauga, ON L5N 5M8
Telephone: 1-888-762-4388
Fax: 1-905-542-5610
Actemra, Tocilizumab Solution, 200 mg/10 mL, 
Intravenous Use
Canadian Actemra (Health Canada, DIN: 02350106) in global EFA packaging and labelling (Global Trade Item Number: 00056090899314) Hoffmann-La Roche N/A February 22, 2021 June 1, 2022 Contact Hoffmann-La Roche at:
7070 Mississauga Road
Mississauga, ON L5N 5M8
Telephone: 1-888-762-4388
Fax: 1-905-542-5610
Actemra, Tocilizumab Solution, 400 mg/20 mL, 
Intravenous Use
Canadian Actemra (Health Canada, DIN: 02350114) in global EFA packaging and labelling (Global Trade Item Number: 07640128015208) Hoffmann-La Roche N/A February 22, 2021 June 1, 2022 Contact Hoffmann-La Roche at:
7070 Mississauga Road
Mississauga, ON L5N 5M8
Telephone: 1-888-762-4388
Fax: 1-905-542-5610
PrismaSol BGK4/0/1.2, Multiple Medical Ingredients (CRRT) Solution,Dialysis, Intravenous Use United States, Food and Drug Administration NDC 24571-114-06 Baxter Corporation N/A July 12, 2021 June 30, 2022 Contact Baxter Corporation at:
7125 Mississauga Rd.,
Mississauga, ON,
L5N 0C2
Telephone: 1-888-719-9955
Fax: 1-905-369-6560
PrismaSATE BK0/3.5 Multiple Medical Ingredients (CRRT) Solution,Dialysis, Intravenous Use Mexico, Comisión Federal para la Protección contra Riesgos Sanitarios, License number: 2369C2009 SSA
Product Code: 105353
Baxter Corporation N/A July 12, 2021 June 30, 2022 Contact Baxter Corporation at:
7125 Mississauga Rd.,
Mississauga, ON,
L5N 0C2
Telephone: 1-888-719-9955
Fax: 1-905-369-6560
PrismaSol BGK4/2.5 Multiple Medical Ingredients (CRRT) Solution,Dialysis, Intravenous Use United States, Food and Drug Administration
NDC: 24571-105-06
Baxter Corporation N/A July 12, 2021 June 30, 2022 Contact Baxter Corporation at:
7125 Mississauga Rd.,
Mississauga, ON,
L5N 0C2
Telephone: 1-888-719-9955
Fax: 1-905-369-6560
Yellow Jacket Venom Protein, Yellow Jacket Venom Protein Powder for Solution, 550 MCG/VIAL, Subcutaneous United States,
Food and Drug
Administration,
National Drug
Code (NDC) 65044-9944-5
Omega Laboratories N/A August 4, 2022 January 31, 2023 Contact Omega Laboratories at:
11177 Hamon Street,
Montreal, QC
H3M 3E4
Telephone: 1.800.363.0584
Fax: (514) 339.1407
Email : info@omegalabs.ca
White-Faced Hornet Venom Protein, White-Faced Hornet Venom Protein Powder for Solution, 550 MCG/VIAL, Subcutaneous United States,
Food and Drug
Administration,
National Drug
Code (NDC) 65044-9941-5
Omega Laboratories N/A August 4, 2022 January 31, 2023 Contact Omega Laboratories at:
11177 Hamon Street,
Montreal, QC
H3M 3E4
Telephone: 1.800.363.0584
Fax: (514) 339.1407
Email : info@omegalabs.ca
Zepzelca, lurbinectedin Sterile powder, 4mg/vial, Intravenous Infusion United States, Food and Drug Administration, National Drug Code (NDC): 68727-712-01 Jazz Pharmaceuticals Canada Inc. 1888484, 1000 vials April 25, 2022 June 30, 2022 Contact Jazz Pharmaceuticals Canada Inc. at:
4080 Confederation Parkway, Suite 602,
Mississauga, ON, Canada
L5B 0G1
Phone: 647-946-8801
Fax: 647-946-8802

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