List of drugs for exceptional importation and sale

Drugs included on this list are called "designated drugs" and are eligible for the exceptional importation and sale provisions provided for in the Interim Order. The list, which will be updated as required, is incorporated by reference in the IO and is maintained by Health Canada.

Supersedes: 2020-07-28
Date issued: 2020-07-30

Access archived versions of this list.

List of Drugs for Exceptional Importation and Sale
Drug or Class of Drug; Brand Name, Medicinal Ingredient(s) Dosage Form, Strength, Route of Administration Country of Origin and Identifying Code Name of Importer Batch Number Date Information to Support Safe Use Made Available by Importer
Propofol; 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 Dear Healthcare Professional Letter
Midazolam;
Midazolam Injection, USP 2 mg / 2 mL (1 mg / mL),
Midazolam
Solution for injection,
1 mg/1 mL,
Intravenous and intermuscular use
USA, ANDA 203460 Fresenius Kabi Canada Ltd. N/A April 17, 2020 Contact Fresenius Kabi Canada at:
100-165 Galaxy Blvd.,
Toronto, ON
M9W 0C8
Telephone: 1-877-779-7760;
Fax: 1-844-605-4465
Ketamine;
Ketamine Hydrochloride Injection USP 500mg/5mL,
Ketamine Hydrochloride
Solution - concentrate,
100mg/mL,
Intramuscular or intravenous use
United States,
National Drug Code (NDC): 00409-2051-05
Pfizer Canada ULC N/A April 17, 2020 Dear Healthcare Professional Letter
Norepinephrine;
Levophed Injection USP 4mg/4mL,
Norepinephrine Bitartrate
Solution - concentrate,
1mg/mL,
Intravenous infusion following dilution
United States,
National Drug Code (NDC): 00409-3375-04
Pfizer Canada ULC N/A April 17, 2020 Contact Pfizer Canada at:
17300 Trans-Canada Hwy.,
Kirkland, QC
H9J 2M5
Telephone: 1-866-723-7111
Fax: 1-855-242-5652
Midazolam;
Midazolam Injection USP 2mg/2mL,
Midazolam
Solution,
1mg/mL,
Intramuscular or intravenous use
United States,
National Drug Code (NDC): 00409-2305-17
Pfizer Canada ULC N/A April 17, 2020 Contact Pfizer Canada at:
17300 Trans-Canada Hwy.,
Kirkland, QC
H9J 2M5
Telephone: 1-866-723-7111
Fax: 1-855-242-5652
Midazolam;
Midazolam Injection USP 5mg/5mL,
Midazolam
Solution,
1mg/mL,
Intramuscular or intravenous use
United States,
National Drug Code (NDC): 00409-2305-05
Pfizer Canada ULC N/A April 17, 2020 Contact Pfizer Canada at:
17300 Trans-Canada Hwy.,
Kirkland, QC
H9J 2M5
Telephone: 1-866-723-7111
Fax: 1-855-242-5652
Midazolam;
Midazolam Injection USP 10mg/10mL,
Midazolam
Solution,
1mg/mL,
Intramuscular or intravenous use
United States,
National Drug Code (NDC): 0409-2587-05
Pfizer Canada ULC N/A April 17, 2020 Contact Pfizer Canada at:
17300 Trans-Canada Hwy.,
Kirkland, QC
H9J 2M5
Telephone: 1-866-723-7111
Fax: 1-855-242-5652
Pancuronium;
Pancuronium Bromide Injection USP 10mg/10mL,
Pancuronium Bromide
Solution,
1mg/mL,
Intravenous use only
United States,
National Drug Code (NDC): 00409-4646-01
Pfizer Canada ULC N/A April 17, 2020 Dear Healthcare Professional Letter
Dexmedetomidine;
Precedex injection 200mcg/2mL,
Dexmedetomidine Hydrochloride
Solution - concentrate,
100mcg/mL,
Intravenous use
United States,
National Drug Code (NDC): 00409-1638-02
Pfizer Canada ULC N/A April 17, 2020 Contact Pfizer Canada at:
17300 Trans-Canada Hwy.,
Kirkland, QC
H9J 2M5
Telephone: 1-866-723-7111
Fax: 1-855-242-5652
Dexmedetomidine;
Precedex injection 400mcg/100mL,
Dexmedetomidine Hydrochloride
Solution,
4mcg/mL,
Intravenous use
United States,
National Drug Code (NDC): 00409-1660-10
Pfizer Canada ULC N/A April 17, 2020 Contact Pfizer Canada at:
17300 Trans-Canada Hwy.,
Kirkland, QC
H9J 2M5
Telephone: 1-866-723-7111
Fax: 1-855-242-5652
Succinylcholine Chloride;
Quelicin Injection USP 200mg/10mL,
Succinylcholine Chloride
Solution,
20mg/mL,
Intramuscular or intravenous use
United States,
National Drug Code (NDC): 00409-6629-02
Pfizer Canada ULC N/A April 17, 2020 Dear Healthcare Professional Letter
Rocuronium;
Rocuronium Bromide injection 100mg/10mL,
Rocuronium Bromide
Solution,
10mg/mL,
Intravenous use only
United States,
National Drug Code (NDC): 00409-9558-10
Pfizer Canada ULC N/A April 17, 2020 Dear Healthcare Professional Letter
Vecuronium;
Vecuronium Bromide for Injection 10mg,
Vecuronium Bromide
Powder for solution,
Intravenous use only
United States,
National Drug Code (NDC): 00409-1632-01
Pfizer Canada ULC N/A April 17, 2020 Dear Healthcare Professional Letter
Rocuronium Bromide;
Rocuronium Bromide Injection,
Rocuronium Bromide
Solution (sterile),
50mg/5mL (10mg/mL),
Intravenous use
United States,
National Drug Code (NDC): 70860-651-05;
70860-651-41,
ANDA: 205656
SteriMax Inc. N/A May 1, 2020 Dear Healthcare Professional Letter
Salbutamol;
Salbutamol Aldo-Union,
Salbutamol Sulfate
Metered-Dose Aerosol, 100mcg per actuation,
Inhalation
Spain,
National Health Care Reimbursement Number (NHRN): 797183.2
TLDO; M.A. No. 65.850
JAMP Pharma Corporation N/A May 7, 2020 Dear Healthcare Professional Letter
Azithromycin;
Azithromycin for Injection USP,
Azithromycin Dihydrate
Powder for solution,
500mg/vial,
Intravenous use
Canada,
DIN: 02239952
SteriMax Inc. 200570110 May 7, 2020 Canadian Product Monograph
Fentanyl;
Fentanyl Kalceks,
Fentanyl Citrate
Liquid solution for injection,
50mcg/ml - 10ml ampoules,
Intramuscular or intravenous use
Malta,
MA1207/00202
Innomar Strategies Inc. on behalf of JAMP Pharma Corporation N/A May 7, 2020 Contact JAMP Pharma at:
1310 Nobel St.,
Boucherville, QC
J4B 5H3
Telephone: 1-866-399-9091 x 2
Fentanyl;
Fentanyl Citrate - Kalceks,
Fentanyl Citrate
Liquid solution for injection,
50mcg/ml - 2ml ampoules,
Intramuscular or intravenous use
Latvia,
14-0232
Innomar Strategies Inc. on behalf of JAMP Pharma Corporation N/A May 7, 2020 Contact JAMP Pharma at:
1310 Nobel St.,
Boucherville, QC
J4B 5H3
Telephone: 1-866-399-9091 x 2
Morphine;
Morphine Sulfate,
Morphine Sulfate Pentahydrate
Solution,
2mg/mL,
Intramuscular, intravenous, and subcutaneous use
Australia,
AUST R 308716
Innomar Strategies Inc. on behalf of JAMP Pharma Corporation N/A May 7, 2020 Contact JAMP Pharma at:
1310 Nobel St.,
Boucherville, QC
J4B 5H3
Telephone: 1-866-399-9091 x 2
Morphine;
Morphine Sulfate,
Morphine Sulfate Pentahydrate
Solution,
10mg/mL,
Intramuscular, intravenous, and subcutaneous use
Australia,
AUST R 308718
Innomar Strategies Inc. on behalf of JAMP Pharma Corporation N/A May 7, 2020 Contact JAMP Pharma at:
1310 Nobel St.,
Boucherville, QC
J4B 5H3
Telephone: 1-866-399-9091 x 2
Morphine;
Morphine Sulfate,
Morphine Sulfate Pentahydrate
Solution,
15mg/mL,
Intramuscular, intravenous, and subcutaneous use
Australia,
AUST R 308715
Innomar Strategies Inc. on behalf of JAMP Pharma Corporation N/A May 7, 2020 Contact JAMP Pharma at:
1310 Nobel St.,
Boucherville, QC
J4B 5H3
Telephone: 1-866-399-9091 x 2
Morphine;
Morphine Sulfate Injection USP,
Morphine Sulfate
Solution,
5mg/mL,
Intramuscular, intravenous, and subcutaneous use
United States,
National Drug Code (NDC): 76045-006-10
Fresenius Kabi Canada Ltd. N/A May 7, 2020 Contact Fresenius Kabi Canada at:
100-165 Galaxy Blvd.,
Toronto, ON
M9W 0C8
Telephone: 1-877-779-7760;
Fax: 1-844-605-4465
Morphine;
Morphine Sulfate Injection USP,
Morphine Sulfate
Solution,
4mg/mL
Intramuscular, intravenous, and subcutaneous use
United States,
National Drug Code (NDC): 76045-005-10
Fresenius Kabi Canada Ltd. N/A May 7, 2020 Contact Fresenius Kabi Canada at:
100-165 Galaxy Blvd.,
Toronto, ON
M9W 0C8
Telephone: 1-877-779-7760;
Fax: 1-844-605-4465
Morphine;
Morphine Sulfate Injection USP,
Morphine Sulfate
Solution,
2mg/mL,
Intramuscular, intravenous, and subcutaneous use
United States,
National Drug Code (NDC): 76045-004-10
Fresenius Kabi Canada Ltd. N/A May 7, 2020 Contact Fresenius Kabi Canada at:
100-165 Galaxy Blvd.,
Toronto, ON
M9W 0C8
Telephone: 1-877-779-7760;
Fax: 1-844-605-4465
Norepinephrine;
Norepinephrine Bitartrate Injection, USP 4mg/4mL (1mg/mL),
Norepinephrine Bitartate
Injection,
1mg/mL,
Intravenous use
United States,
National Drug Code (NDC): 36000-162-10
Product Code: AIN00610
Baxter Corporation N/A May 8, 2020 Contact Baxter Corporation at:
7125 Mississauga Rd.,
Mississauga, ON,
L5N 0C2
Telephone: 1-800-387-8399
Fax: 1-905-369-6560
Rocuronium;
Rocuronium Bromide Injection,
Rocuronium Bromide
Solution for injection (50mg/5mL),
10mg/mL,
Intravenous use
United States,
National Drug Code (NDC): 70860-651-05;
70860-651-41
Laboratoire Riva Inc. N/A May 8, 2020 Dear Healthcare Professional Letter
Hydromorphone;
Hydromorphone Kalceks,
Hydromorphone Hydrochloride
Solution, 2mg/mL,
Intramuscular, intravenous, or subcutaneous use
Germany,
M.A No. (Zulassungnummer): 2201455.00.00
Innomar Strategies Inc. on behalf of JAMP Pharma Corporation N/A May 11, 2020 Contact JAMP Pharma at:
1310 Nobel St.,
Boucherville, QC
J4B 5H3
Telephone: 1-866-399-9091 x 2
Hydromorphone; Hydromorphone Kalceks,
Hydromorphone Hydrochloride
Solution, 10mg/mL,
Intramuscular, intravenous, or subcutaneous use
Germany,
M.A No. (Zulassungnummer): 2201456.00.00
Innomar Strategies Inc. on behalf of JAMP Pharma Corporation N/A May 11, 2020 Contact JAMP Pharma at:
1310 Nobel St.,
Boucherville, QC
J4B 5H3
Telephone: 1-866-399-9091 x 2
Hydromorphone; Hydromorphone Kalceks,
Hydromorphone Hydrochloride
Solution, 20mg/mL,
Intramuscular, intravenous, or subcutaneous use
Germany,
M.A No. (Zulassungnummer): 2201457.00.00
Innomar Strategies Inc. on behalf of JAMP Pharma Corporation N/A May 11, 2020 Contact JAMP Pharma at:
1310 Nobel St.,
Boucherville, QC
J4B 5H3
Telephone: 1-866-399-9091 x 2
Hydromorphone; Hydromorphone Kalceks,
Hydromorphone Hydrochloride
Solution, 50mg/mL,
Intramuscular, intravenous, or subcutaneous use
Germany,
M.A No. (Zulassungnummer): 2201458.00.00
Innomar Strategies Inc. on behalf of JAMP Pharma Corporation N/A May 11, 2020 Contact JAMP Pharma at:
1310 Nobel St.,
Boucherville, QC
J4B 5H3
Telephone: 1-866-399-9091 x 2
Meropenem;
Meropenem 1000 mg Powder for Solution for Injection or Infusion,
Meropenem Trihydrate
Powder for solution,
1000mg,
Intravenous use
Ukraine,
Ukraine Registration No. UA/17558/01/01, Manufacturing License No. G/28/1581
Strides Pharma Canada Inc. N/A May 12, 2020 Contact Strides Pharma Canada at:
1565 Boulevard Lionel-Boulet,
Varennes, QC
J3X 1P2
Telephone: 1-514-731-2003
Timolol;
Timo-Stulln,
Timolol Maleate
Ophthalmic solution,
0.5%,
Ophthalmic Use
Germany,
06879051
Pharma
Stulln Inc.
N/A May 15, 2020 Contact Pharma Stulln at:
400-6500 TransCanada hwy.,
Pointe-Claire, QC
H9R 0A5
Telephone: 1-833-278-8556
Salbutamol;
Salbuhaler,
Salbutamol Sulfate
Metered-Dose Aerosol,
100 mcg per actuation,
Inhalation
Philippines,
DRP-3645
Sandoz
Canada
Inc.
N/A May 15, 2020 Contact Sandoz Canada at :
110 de Lauzon,
Boucherville, QC
J4B 1E6
Telephone: 1-800-343-8839
Succinylcholine;
Anectine,
Succinylcholine Chloride
Solution for injection,
200mg/10mL (20mg/mL),
Intravenous use
United States,
National Drug Code (NDC) - Box: 0781-9053-95; Vial: 0781-9053-70
Sandoz Canada Inc. N/A May 20, 2020 Contact Sandoz Canada at:
110 de Lauzon,
Boucherville, QC
J4B 1E6
Telephone: 1-800-343-8839
Midazolam;
Sedozolam Solution for Injection or Infusion,
Midazolam
Solution,
5mg/5mL (1mg/1mL),
Intravenous or intramuscular use
Turkey,
Register Number: 2016/246
Innomar Strategies Inc. on behalf of JAMP Pharma Corporation N/A June 9, 2020 Contact JAMP Pharma at:
1310 Nobel St.,
Boucherville, QC
J4B 5H3
Telephone: 1-866-399-9091 x 2
Midazolam;
Sedozolam Solution for Injection or Infusion,
Midazolam
Solution,
15mg/3mL (5mg/1mL),
Intravenous or intramuscular use
Turkey,
Register Number: 2016/290
Innomar Strategies Inc. on behalf of JAMP Pharma Corporation N/A June 9, 2020 Contact JAMP Pharma at:
1310 Nobel St.,
Boucherville, QC
J4B 5H3
Telephone: 1-866-399-9091 x 2
Cisatracurium;
Cisatracurium Besylate Injection,
Cisatracurium Besylate
Solution for injection,
20mg/10ml (2mg/ml),
Intravenous use
United States,
National Drug Code (NDC) – Inner label: 0781-3152-70;
Outer label (box of 10): 0781-3152-95
Sandoz Canada Incorporated N/A June 15, 2020 Contact Sandoz Canada at:
110 de Lauzon,
Boucherville, QC
J4B 1E6
Telephone: 1-800-343-8839
Propylthiouracil;
PTU™,
Propylthiouracil
Tablet,
50mg,
Oral use
Australia,
AUST R 13313
Phebra Canada Inc. N/A June 18, 2020 Company Communications for Healthcare Professionals
Chlorambucil;
Leukeran,
Chlorambucil
Tablet,
2mg,
Oral use
South Africa,
A: 26 H2747
Aspen Pharmacare Canada Inc. 902787 July 18, 2020 Contact Aspen Pharmacare Canada Inc. at:
8 - 1155 North Service Road West,
Oakville, Ontario
L6M 3E3
Telephone: 1-844-330-1213
Propofol;
Disoprivan 1%,
Propofol
Solution,
500mg/50mL (1%),
Intravenous use
Switzerland,
47162 076
Aspen Pharmacare Canada Inc. N/A July 23, 2020 Contact Aspen Pharmacare Canada Inc. at:
8 - 1155 North Service Road West,
Oakville, Ontario
L6M 3E3
Telephone: 1-844-330-1213
Phenelzine Sulfate;
Phenelzine Sulfate Tablets USP,
Phenelzine Sulfate
Tablets,
15mg,
Oral use
United States,
National Drug Code (NDC): 43386-360-21
Lupin Pharma Canada Limited N/A July 24, 2020 Contact Lupin Pharma Canada Limited at:
QC:
304-1001 De Maisonneuve East,
Montreal, Quebec,
H2L 4P9
ON:
707-15 Wertheim Ct,
Richmond Hill, Ontario
L4B 3H7
Telephone: 1 844-587-4623
Rocuronium;
Rocuronium Bromide injection,
Rocuronium Bromide
Solution for injection,
50mg/5mL (10mg/mL),
Intravenous use
United States, National Drug Code (NDC) – Vial: 72611-756-01; Carton: 72611-756-10 Marcan Pharmaceuticals Inc. N/A July 24, 2020 Contact Marcan Pharmaceuticals Inc. at:
112 – 2 Gurdwara Road,
Ottawa, Ontario
K2E 1A2
Telephone: 1-613-228-2600
Azithromycin;
Azithromycin for Injection, USP,
Azithromycin monohydrate
Powder for solution,
500mg/vial, Intravenous use
United States, National Drug Code (NDC): 70860-100-41 Marcan Pharmaceuticals Inc. N/A July 28, 2020 Contact Marcan Pharmaceuticals Inc. at:
112 – 2 Gurdwara Road,
Ottawa, Ontario
K2E 1A2
Telephone: 1-613-228-2600
Acyclovir;
Acyclovir Sodium Injection,
Acyclovir sodium
Solution, 500mg/10mL, Intravenous use United States, National Drug Code: 55150-154-10 Auro Pharma Inc. N/A July 30, 2020 Contact Auro Pharma Inc. at:
3700 Steeles Avenue West, Suite # 402,
Woodbridge, ON L4L 8K8,
Telephone: +1-905 856-8063 / +1-905 856-8263
Fax: +1-905 856-8094
Acyclovir;
Acyclovir Sodium Injection,
Acyclovir sodium
Solution, 1000mg/20mL, Intravenous use United States, National Drug Code: 55150-154-20 Auro Pharma Inc. N/A July 30, 2020 Contact Auro Pharma Inc. at:
3700 Steeles Avenue West, Suite # 402,
Woodbridge, ON L4L 8K8
Telephone: +1-905 856-8063 / +1-905 856-8263
Fax: +1-905 856-8094
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