List of drugs for exceptional importation and sale

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: 2024-11-15
Date issued: 2024-11-23

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
Idarubicin hydrochloride 1 mg/mL in 5 mL, 10 mL, and 20 mL vials, Solution for Injection United States of America FDA NDC 0143-9217-01 (5mL), NDC 0143-9218-01 (10mL), NDC 0143-9219-01 (20mL) Hikma Canada Limited N/A October 31, 2024 January 31, 2025 Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, ON L5R 3P9
Biltricide, praziquantel

Tablet, 600 mg, oral

Benin, 4062/93

Burkina Faso, 005742005XC112000

Cameroon, 92.07.0391 RV

Congo, 007-R-92 /M2.22.01/05-113-RVC

Cote D'Ivoire, E-95-0070

Gabon, 3712/94/04

Guinea, 50031

Madagascar, 31.1.1.062

Niger, 72494

Senegal, 1474

Chad, 96 500 802

Togo, SP.TG. 1371

Bayer Inc. N/A August 30, 2024 December 31, 2024 Bayer Inc
292 Matheson Blvd. E.
Mississauga, ON
L4W 5R6
Email: Canada.medinfo@bayer.com
Phone: 1-800-265-7382
Pantoprazole Sodium for Injection, Pantoprazole Sodium USP Lyophilized powder for injection, 40 mg/vial, intravenous infusion United States, Food and Drug Administration, NDC 0143-9284-10 Hikma Canada Limited N/A July 26, 2024 November 1, 2024

Contact Hikma Canada Limited at:
5995 Avebury Road, Suite 804
Mississauga, ON
Canada L5R 3P9

Phone: 1-800-656-0793

Beyfortus, nirsevimab Solution, 50 mg/0.5 mL, Intramuscular France, National Agency for the Safety of Medicine and Health Products, EU/1/22/1689/002 Sanofi Pasteur Limited N/A July 19, 2024 September 30, 2024

Contact Sanofi Pasteur Limited at 1755 Steeles Avenue West, Toronto, Ontario, Canada, M2R 3T4.

Telephone: 1-800-265-7927

Beyfortus, nirsevimab Solution, 100 mg/1 mL, Intramuscular France, National Agency for the Safety of Medicine and Health Products, EU/1/22/1689/005 Sanofi Pasteur Limited N/A July 19, 2024 September 30, 2024

Contact Sanofi Pasteur Limited at 1755 Steeles Avenue West, Toronto, Ontario, Canada, M2R 3T4.

Telephone: 1-800-265-7927

Calcitriol Injection USP, Calcitriol Sterile solution, 1 mcg/mL, intravenous United States, Food and Drug Administration, NDC 72266-251-10 Sterimax Inc. N/A June 14, 2024 May 1, 2025

Contact SteriMax Inc. at:
2770, Portland Drive, Oakville, ON, L6H 6R4
Phone: +1-800-881-3550
Fax: +1 -877-546-7667
E-mail: medinfo@sterimaxinc.com

Colestyramin Orifarm, cholestyramine resin Powder for suspension, 4 g, oral Denmark, Danish Medicines Agency, 59339 Septa Pharmaceuticals Inc. N/A August 14, 2024 October 15, 2024

Septa Pharmaceuticals Inc.

7035 Maxwell Road, Unit 2 
Mississauga, ON L5S 1R5 
Phone: 905-564-5665
Email: orders@septapharma.com

Orencia, abatacept Solution, 125 mg/mL, Subcutaneous Saudi Arabia, Saudi Food and Drug Authority, 1-960-14 Bristol-Myers Squibb Canada Co. N/A June 7, 2024 August 31, 2024 Contact Bristol-Myers Squibb Canada Co. at:
2344, Boul. Alfred-Novel, St-Laurent, Quebec, Canada, H4S 0A4
Telephone: 1-866-463-6267
Email: medical.canada@bms.com
Moxifloxacin Injection, Moxifloxacin Hydrochloride Solution, 400 mg/250 mL, Intravenous United States of America, Food and Drug Administration, NDC# 63323-850-74 (package); 63323-850-04 (single bag) Fresenius Kabi Canada Ltd. N/A May 10, 2024 August 31, 2024

Fresenius Kabi Canada

165 Galaxy Boulevard, Suite 100
Toronto, ON M9W 0C8

Main Phone: 905-770-3711
Toll Free: 1-877-779-7760

Medical Information: Canada_MedInfo@fresenius-kabi.com

Bupivacaine with Adrenaline (Epinephrine) Injection (0.25%), Bupivacaine hydrochloride and Adrenaline (Epinephrine) Solution (sterile) United Kingdom, Medicines and Healthcare products Regulatory Agency, PL 12762/0556 SteriMax Inc. N/A May 28, 2024 December 5, 2024

Contact SteriMax Inc. at:

2770, Portland Drive, Oakville, ON, L6H 6R4

Phone: +1-800-881-3550
Fax: +1-877-546-7667

E-mail: medinfo@sterimaxinc.com

Bupivacaine with Adrenaline (Epinephrine) Injection (0.5%), Bupivacaine hydrochloride and Adrenaline (Epinephrine) Solution (sterile); epidural United Kingdom, Medicines and Healthcare products Regulatory Agency, PL 12762/0557 SteriMax Inc. N/A May 28, 2024 September 1, 2024

Contact SteriMax Inc. at:

2770, Portland Drive, Oakville, ON, L6H 6R4

Phone: +1-800-881-3550
Fax: +1 -877-546-7667

E-mail: medinfo@sterimaxinc.com

Aminophylline Injection, aminophylline hydrate Solution for injection, 25mg/ml, intravenous injection UK, MHRA
PL 12762/0559
Septa Pharmaceuticals Inc. 25,000 ampoules April 26, 2024 July 31, 2024 Contact Septa Pharmaceuticals Inc. at:
Phone: +1-905-564-5665 or
Address:
7035 Maxwell Road, Unit 2, Mississauga, ON, Canada, L5S 1R5
Email: orders@septapharma.com
Aminophylline Injection, aminophylline dihydrate Solution for injection, 25mg/ml, intravenous injection Greece, National Organization for Medicines, 40869/09/03-03-2010 GR Juno Pharmaceuticals Corp.

Lot Number: 2401527

Qty: 10000 ampoules

April 18, 2024 July 31, 2024 Contact Juno Pharmaceuticals Corps. at: 402-2233 Argentia Road,
Mississauga, Ontario,
L5N 2X7, Canada
Phone: +1 905-829-3838
ORENCIA, abatacept Solution, 125 mg/ml, Subcutaneous United States, Food and Drug Administration, National Drug Code (NDC): 0003-2188-11 Bristol-Myers Squibb Canada Co. N/A May 24, 2024 August 31, 2024 Contact Bristol-Myers Squibb Canada Co. at:
2344, Boul. Alfred-Novel,
St-Laurent, Quebec,
Canada, H4S 0A4
Telephone: 1-866-463-6267
Email: medical.canada@bms.com
Thiamine HCl Injection USP, Thiamine hydrochloride Liquid, 200 mg/2 mL (100 mg/mL), Intramuscular or Intravenous use United States, Food and Drug Administration, National Drug Code (NDC) 0641-6228-25 Hikma Canada Limited N/A March 21, 2024 June 1, 2024 Contact
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, ON, L5R 3P9
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. 500 kits February 9, 2024 June 1, 2024 Contact GE Healthcare Canada Inc. at:
1919 Minnesota Court Mississauga, ON, Canada, L5N 0C9
Phone: 866-281-7545
Fomicyt, Fosfomycin Powder for solution, 4g/vial, Intravenous United Kingdom, Medicines and Healthcare products Regulatory Agency, PL15011/0017, PA1972/001/001 Verity Pharmaceuticals Inc. N/A November 30, 2023 May 30, 2024 Contact Verity Pharmaceuticals Inc. at:
2560 Matheson Blvd. East, Suite 220, Mississauga, Ontario, Canada, L4W 4Y9
Phone: 416-800-7771
Glyceryl trinitrate sublingual spray, glyceryl trinitrate Sublingual solution, 400 µg/metered spray, sublingual United Kingdom, Medicines and Healthcare products Regulatory Agency, PL 18190/0013 Juno Pharmaceuticals Corp. N/A November 6, 2023 April 30, 2024 Contact Juno Pharmaceuticals Corp. at: 402-2233 Argentina Road, Mississauga, Ontario, Canada, L5N 2X7
Phone: 905-829-3838
Fax: 905-829-3810
Glucose Intravenous Infusion 50% w/v, glucose Solution, 25 g/50 mL, Intravenous  United Kingdom, Medicines and Healthcare products Regulatory Agency, PL 01502/0005R Juno Pharmaceuticals Corp.   N/A  November 7, 2023 January 15, 2025 Contact Juno Pharmaceuticals Corp. at: 402-2233 Argentina Road, Mississauga, Ontario, Canada, L5N 2X7
Phone: 905-829-3838
Fax: 905-829-3810
Vigabatrin Tablets, USP, Vigabatrin Tablet, 500 mg, Oral  United States, Food and Drug Administration, National Drug Code (NDC):  
43598-651-01
Dr. Reddy's Laboratories Canada Inc.   N/A  October 31, 2023 March 15, 2024  Contact: 
Dr. Reddy's Laboratories Canada Inc.  
5580 Explorer Drive, Suite 204, Mississauga, ON, L4W 4Y1, Canada 
Prazosin hydrochloride Capsules, 1 mg, 2 mg, 5 mg,
Oral
United States, Food and Drug Administration, National Drug Code (NDC)
1mg: 62332-691-31; 2mg: 62332-692-31; 5 mg 62332-693-31
SteriMax Inc. N/A August 4, 2023 December 31, 2024 Contact
SteriMax Inc.
2770 Portland Drive, Oakville, Ontario, L6H6R4
Fasturtec, Rasburicase Powder for Solution, 1.5mg/vial, Intravenous United Kingdom, Medicines and Healthcare products Regulatory Agency, PLGB 04425/0821 Sanofi-Aventis Canada Inc. N/A June 22, 2023 September 15, 2023 Contact Sanofi-Aventis Canada Inc. at:
1755 Steeles Avenue West, Toronto, Ontario, Canada, M2R 3T4
Email: CAINTERNET@sanofi.com
Phone: 1-800-265-7927
Sabril, vigabatrin Tablet, 500mg, Oral United States, Food and Drug Administration, National Drug Code (NDC): 67386-111-01 Lundbeck Canada Inc. N/A May 31, 2023 December 31, 2023 Contact Lundbeck Canada Inc. at: 2600 Alfred-Nobel Suite 400,
St-Laurent,
Quebec, Canada, H4S 0A9
Phone: 514-844-8515 Fax: 514-844-5495
10% Premasol, amino acid solution Solution, 500 mL, Intravenous United States, Food and Drug Administration, National Drug Code (NDC):
0338-1130-03
Baxter Corporation N/A May 31, 2023 August 5, 2023 Contact Baxter Corporation at 1-888-719-9955
Potassium Chloride 15% w/v Concentrate for Solution for Infusion Solution, 15% w/v, Intravenous United Kingdom, Medicines and Healthcare products Regulatory Agency, PL 24598/0003 Juno Pharmaceuticals Corp. N/A October 13, 2023 June 30, 2024 Juno Pharmaceuticals Corp. 402-2233
Argentia Road, Mississauga, Ontario,
L5N 2X7
Canada
Primene 10%, amino acid solution Solution, 250 mL, Intravenous Brazil, Agência Nacional de Vigilância Sanitária (ANVISA), PCA3CG133N79D Baxter Corporation N/A June 12, 2023 August 5, 2023 Contact Baxter Corporation at 1-888-719-9955
10% Premasol, amino acid solution Solution, 1000 mL, Intravenous United States, Food and Drug Administration, National Drug Code (NDC):
0338-1130-04
Baxter Corporation N/A May 31, 2023 August 5, 2023 Contact Baxter Corporation at 1-888-719-9955

Calcitonin Salmon Injection, USP, Synthetic

Calcitonin Salmon

Solution, 200 units

Intramuscular (IM), Subcutaneous (SC)

United States, US FDA, NDC 24201-400-02 Hikma Canada Limited N/A April 24, 2023 September 30, 2024

Contact Hikma Canada Limited at:

5995 Avebury Road, Suite 804
Mississauga, ON
Canada L5R 3P9
Phone: 1-800-656-0793

Cytogam, Cytomegalovirus Immunoglobulin Intravenous (Human) 2500 mg/ml United States of America, Food and Drug Administration, National Drug Code (NDC): 70257-532-51 Accuristix N/A April 21, 2023 January 15, 2024 KI BioPharma LLC
3 Germay Dr, Unit 4 #1302
Wilmington,
Delaware, USA
19804
Email: ki_pv@kibiopharma.com
Phone: 1 866-916-0077
Lipiodol Ultra Fluid solution, iodine (ethiodized oil) 

38% w/w (380 mg iodine/g or 480 mg iodine/mL)
Solution for Injection 

United Kingdom
MHRA 
PL 12308/0022 

Methapharm Inc.  N/A  October 25, 2024 December 31, 2024 

Contact Methapharm
81 Sinclair Boulevard, Brantford, Ontario, Canada N3S 7X6 

Gleostine, 
lomustine 
Capsules, 10 mg & 40 mg, oral United States, Food and Drug Administration, National Drug Code (NDC):  
58181-3040-5 (10 mg), 58181-3041-5 (40 mg)
Septa Pharmaceuticals Inc.  N/A  October 17, 2024 December 31, 2025 

Septa Pharmaceuticals Inc. 
7035 Maxwell Road, Unit 2  
Mississauga, ON L5S 1R5 
Phone: 905-564-5665 
Email: orders@septapharma.com

Lithium Carbonate Capsules, USP, lithium carbonate Capsules, 150 & 300 mg, oral United States, Food and Drug Administration, National Drug Code (NDC): 0054-2526-25 (150 mg), 0054-2527-25 (300 mg), 0054-2527-31 (300 mg) Hikma Canada Limited N/A September 24, 2024 February 28, 2025 Hikma Canada Limited
5995 Avebury Road, Suite 804 
Mississauga, Ontario 
CanadaL5R 3P9 Phone: 
1-800-656-0793
Pantoprazole Sodium for Injection, pantoprazole sodium sesquihydrate Powder for injection, 40 mg/vial, intravenous infusion United States, United States, Food and Drug Administration, National Drug Code (NDC) 65219-433-01 (vial), NDC: 65219-433-15 (carton) Fresenius Kabi Canada Ltd N/A September 26, 2024 April 4, 2025 Fresenius Kabi Canada165 Galaxy Boulevard, Suite 100
Toronto, ON M9W 0C8Main Phone: 905-770-3711
Toll Free: 1-877-779-7760Medical Information: Canada_MedInfo@fresenius-kabi.com
Beyfortus, nirsevimab Solution, 100 mg/1 mL, Intramuscular United States, Food and Drug Administration, National Drug Code (NDC) 49281-574-15 Sanofi Pasteur Limited N/A September 19, 2024 October 30, 2024

Contact Sanofi Pasteur Limited at 1755 Steeles Avenue West, Toronto, Ontario, Canada, M2R 3T4.

Telephone: 1-800-265-7927

Pantoprazol Normogen 40 mg, pantoprazole sodium sesquihydrate Powder for solution, 40 mg/vial, intravenous Spain, Spanish Agency for Medicine and Health Products, 85854 Juno Pharmaceuticals Corp. N/A August 22, 2024 November 1, 2024 Juno Pharmaceuticals Corp. at:
402-2233 Argentina Road,
Mississauga, Ontario,
Canada, L5N 2X7
Biltricide, praziquantel Tablet, 600 mg, oral United States, Food and Drug Administration, National Drug Code (NDC) 50419-747-01 Bayer Inc. N/A August 16, 2024 September 30, 2025 Bayer Inc.
292 Matheson Blvd. E.
Mississauga, ON
L4W 5R6
Email: Canada.medinfo@bayer.com
Phone: 1-800-265-7382
Calcium Chloride / DEMO 10% w/v Solution for Infusion Solution, 10% w/v, Intravenous Greece, National Organization for Medicines, 24623/15/2-8-2016 Juno Pharmaceuticals Corp. N/A December 14, 2023 April 30, 2024 Juno Pharmaceuticals Corp.
402-2233
Argentia Road, Mississauga, Ontario, L5N 2X7
Canada
Cholestyramine for Oral Suspension USP, cholestyramine resin Powder for suspension, 4 g, oral United States, Food and Drug Administration, National Drug Code (NDC) 27241-134-36 Juno Pharmaceuticals Corp. N/A March 30, 2024 March 15, 2025 Juno Pharmaceuticals Corp. 402-2233 Argentia Road,
Mississauga, Ontario,
L5N 2X7, Canada
Ketamine Hydrochlori de Injection, Ketamine Hydrochlori de Solution, 50 mg/mL, Intravenous (IV),
Intramuscular (IM)
United Kingdom, UK MHRA, PL 01502/ 0099 Juno Pharmace uticals Corp N/A April 6, 2023 October 7,
2023

Juno Pharmaceuti cal Corp,

402-2233
Argentia Road, Mississauga, Ontario, L5N 2X7,
Canada
Phone: 1
(888)-882-
8827
E-mail: customerservice@junop harm.com

https://www.junopharm.ca/

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
Histatrol, histamine phosphate Solution, 2.75 mg/mL and 0.275 mg/mL, intradermal United States of America, Food and Drug Administration,
NDC #0268-0247-05 (2.75 mg/mL) and
NDC #0268-0248-05 (0.275 mg/mL)
ALK-Abello Pharmaceuticals Inc. N/A February 20, 2023 December 31, 2025 Contact ALK-Abello Inc. at
151 Brunel Road, Suite 32-35
Mississauga, ON Canada L47 2H6
Tel: 1-289-374-6317
Miostat,
Carbachol
Solution, 0.01%,
Intraocular
United States, US FDA, NDC 0065-0023-15 Alcon Canada Inc N/A February 16, 2023 April 1, 2023

Alcon Canada, Inc.
2665 Meadowpine Blvd. Mississauga, ON
L5N 8C7

Phone: +1905-826-6700
Fax: +1905-567-0592
www.alcon.ca

BSS Sterile Irrigating Solution, balanced salt solution Solution, 500 mL, Irrigation United States, Food and Drug Administration, National Drug Code (NDC):
0065-1795-04
Alcon Canada Inc. N/A February 16, 2023 June 30, 2023 Contact Alcon Canada Medical Information at canada.medinfo@Alcon.com or 1-800-613-2245
Omnipaque 300, Iohexol Solution, 647 mg/mL, intrathecal, intravascular, oral or rectal, intra-arterial, body cavity; IBP - intravenous United States, Food and Drug Administration, National Drug Code (NDC):
0407-1413-63 and
0407-1413-72
GE Healthcare Canada Inc. N/A December 22, 2022 TBD

Contact GE Healthcare Canada Inc. at: 1919 Minnesota Court
Mississauga, ON, Canada
L5N 0C9

Phone: 866-281-7545

Eptifibatide Solution, 0.75mg/mL & 2mg/mL, Intravenous United Kingdom, Medicines and Healthcare products Regulatory Agency, PL number:
0.75mg/ml - PL44853/0002;
2mg/mL - PL44853/0003
Juno Pharmaceuticals Corp. TBD, 0.75mg/mL - 6000 units; 2mg/mL – 5000 units January 23, 2023 July 20, 2023

Contact Juno Pharmaceuticals Corp. at: 402-2233 Argentina Road, Mississauga, Ontario, Canada, L5N 2X7

Phone: 905-829-3838

Fax: 905-829-3810

Visipaque 320, Iodixanol Solution, 652mg/mL, intra-arterial, intravenous United States, Food and Drug Administration, National Drug Code NDC: 0407-2223-17, 0407-2223-21 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
Amiodarone Hydrochloride Injection, USP, Amiodarone Hydrochloride Solution, 50 mg/mL, Intravenous United States, Food and Drug Administration, National Drug Code (NDC): 0143-9875-01, 0143-9875-25, 0143-9875-10 Hikma Canada Limited N/A November 16, 2022 January 31, 2023 Contact Hikma Canada Limited at:
5995 Avebury Road, Suite 804
Mississauga, ON
Canada L5R 3P9
Phone: 1-800-656-0793
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 October 27, 2023 December 8, 2023 Contact Pfizer Canada at:
17300 Trans-Canada Hwy.,
Kirkland, QC
H9J 2M5
Telephone: 1-866-723-7111
Fax: 1-855-242-5652
Dexrazoxane for injection, Dexrazoxane Powder for solution, 250 mg, Intravenous United States, US FDA, NDC 0143-9247-01 Hikma Canada Limited N/A March 24, 2023 December 31, 2023 Hikma Canada Limited,
5995 Avebury Road,
Suite 804
Mississauga
Ontario
Canada L5R 3P9
Phone:
1.800.656.0793
www.hikma.com
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
Viberzi, eluxadoline Tablets, 75 & 100 mg,
Oral
United States, Food and Drug Administration, National Drug Code (NDC) 61874-075-60 (75 mg) and NDC 61874-100-60 (100 mg) AbbVie Corporation N/A October 5, 2022 January 31, 2025 Contact AbbVie Corporation at:
8401 route Transcanadienne
Saint-Laurent, QC
H4S 1Z1
Arganova, Argatroban Solution, 100 mg/mL, Intravenous France, National Agency for the Safety of Medicine and Health Products, 34009 277 480 0 4 Sandoz Canada Inc. 1984195E
2068570B
2095479C
2095481A
2095481D
October 5, 2022 November 30, 2023 Contact Sandoz Canada Inc. at:
110 rue de Lauzon,
Boucherville, QC
J4B 1E6
Telephone: 1-800-361-3062
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
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 September 30, 2022 Contact Pfizer Canada at:
7300 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
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
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
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,W065343
April 4, 2022 November 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
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
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
Vigabatrin Powder, 500mg/sachet, Oral United States, Food and Drug Administration, National Drug Code (NDC): 43598-697-11, 43598-697-50 Dr. Reddy's Laboratories Canada Inc. N/A September 15, 2023 June 15, 2024 Contact:
Dr. Reddy's Laboratories Canada Inc.
5580 Explorer Drive, Suite 204, Mississauga, ON L4W 4Y1 Canada
Collagenase SANTYL Ointment, Collagenase Ointment, 250 units/g, Topical United States, Food and Drug Administration, National Drug Code (NDC): 50484-010-30 Smith & Nephew Inc. N/A September 15, 2023 March 31, 2025 Contact Smith & Nephew Inc. at: 2280 Argentina Road
Mississauga, Ontario
L5N 6H8 Canada
https://smith-nephew.com/en-ca/contact-us#ap-cards
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 October 31, 2022 Contact Hikma Canada Limited at:
5995 Avebury Road, Suite 804
Mississauga, ON
Canada L5R 3P9
Phone: 1-800-656-0793
Lorazepam Injection 4 mg/mL
Intramuscular, Intravenous
United States, Food and Drug Administration, National Drug Code (NDC) 0641-6045-25 Innomar Strategies inc. on behalf of Hikma Canada Limited N/A September 23, 2022 December 15, 2022 Contact Hikma Canada Limited at:
5995 Avebury Road, Suite 804
Mississauga, ON L5R 3P9
Moxilen Forte, Amoxicillin trihydrate Powder for oral suspension, 250 mg/5 mL, Oral Kosovo, Kosovo Medicines Agency, Renewal Marketing Authorization 2603/16/11/2021 Juno Pharmaceuticals Corp. N/A December 28, 2022 April 30, 2023 Contact Juno Pharmaceuticals Corp. at:
402-2233 Argentia Road,
Mississauga, Ontario,
L5N 2X7, Canada
Moxilen Forte, Amoxicillin trihydrate Powder for oral suspension, 250 mg/5 mL, Oral Cyprus, Ministry of Health – Pharmaceutical Services, 007277 Juno Pharmaceuticals Corp. N/A December 28, 2022 March 31, 2024 Contact Juno Pharmaceuticals Corp. at:
402-2233 Argentia Road,
Mississauga, Ontario,
L5N 2X7, Canada
Oncaspar, Pegaspargase Solution for Injection or Infusion, 3,750units/5mL, Intravenous, Intramuscular United States, Food and Drug Administration, National Drug Code (NDC): 72694-954-01 Servier Canada Inc. 2227A, 2493A February 3, 2023 February 15, 2024

Contact Servier Canada Inc. at:
3224, Avenue Jean-Béraud #270, Laval, Québec, Canada, H7T 2S4

Phone: 450-978-9700

Company Communication for Healthcare Professionals:

https://multimedia.eservier.com/servierfr-0/documents/171c46e6-1137-4046-8f4c-82e921ab67ff.pdf

PEYONA, caffeine citrate Solution for infusion, intravenous or oral solution, oral United Kingdom, Medicines and Healthcare products Regulatory Agency, PLGB 08829/0189 Methapharm Inc. N/A November 8, 2022 December 12, 2022 Contact Methapharm Inc. at:
81 Sinclair Boulevard, Brantford, ON, N3S 7X6
Tel: 519-751-3602
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
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 BGK4/0/1.2, 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
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
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
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
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
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
Sabril, vigabatrin Powder, 500 mg/sachet, Oral United States, Food and Drug Administration, National Drug Code (NDC): 67386-211-65 Lundbeck Canada Inc. N/A, 2,000 units September 26, 2022 February 28, 2023

Contact Lundbeck Canada Inc. at: 2600 Alfred-Nobel Suite 400,
St-Laurent,
Quebec, Canada, H4S 0A9

Phone: 514-844-8515

Fax: 514-844-5495

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
Magnesium Sulfate 50% w/v Solution for Injection, Magnesium Sulfate (heptahydrate) Solution, 500 mg/mL (5g/10mL), Intravenous, Intramuscular United Kingdom, Medicines and Healthcare products Regulatory Agency, MIA 1883 SteriMax Inc. N/A October 19, 2022 November 30, 2022 Contact SteriMax Inc. at:
2770, Portland Drive, Oakville, ON, L6H 6R4
Phone: +1-800-881-3550
Fax: +1 -877-546-7667
E-mail: medinfo@sterimaxinc.com
Rylaze
CRISANTASPASE
10 mg/0.5 mL
Solution for intramuscular injection
United States, US FDA, NDC 68727-900-03 Jazz Pharmaceuticals Canada COM6, COM7 October 19, 2022 February 28, 2023 Jazz Pharmaceuticals Canada, Inc.
4080 Confederation Parkway
Suite 602
Mississauga, Ontario
L5B 0G1
Main Line: 647-946-8801
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
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 October 31, 2024 Contact Omega Laboratories at:
11177 Hamon Street,
Montreal, QC
H3M 3E4
Telephone: 1.800.363.0584
Fax: (514) 339.1407
Email: info@omegalabs.ca
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
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
Ketamine HCl Solution for Injection, Ketamine Hydrochloride

Solution, 500 mg/10 ml,

Intravenous (IV), Intramuscular (IM)

Portugal, Infarmed, PL 01502/ 0099 Hikma Canada Limited N/A May 19, 2023 October 7, 2023

Contact Hikma Canada Limited at:

5995 Avebury Road, Suite 804
Mississauga, ON, Canada
L5R 3P9
Phone: 1-800-656-0793

Glucagon Injection, glucagon Kit, 1 mg/vial, intramuscular, intravenous, subcutaneous

United States, Food and Drug Administration, National Drug Code (NDC):

0548-5850-00

Amphastar Pharmaceuticals Inc. N/A May 19, 2023 December 31, 2025

Contact Amphastar Pharmaceuticals Inc. at:

11570 6th Street,
Rancho Cucamonga, California, USA, 91730
Phone: 1-800-423-4136

Dipyridamole Injection, USP, dipyridamole Solution, 5 mg/mL, Intravenous United States, Food and Drug Administration, National Drug Code (NDC): 0641-2569-41 (single vial) 0641-2569-44
(5-vial pack)
Hikma Canada Limited N/A June 30, 2023 January 31, 2024 Contact Hikma Canada at 1-800-656-0793 or emailing Canada_drugsafety@hikma.com
APO-go Pen, Apomorphine Hydrochloride Solution, 10 mg/mL, Subcutaneous United Kingdom, Medicines and Healthcare Products Regulatory Agency, PL 04483/0073 Accuristix N/A December 11, 2023 December 31, 2024 Accuristix
100 Vaughan Valley Boulevard
Vaughan, Ontario, Canada
L4H 3C5
905-829-9927
Cisatracurio Hikma 2 mg/ml, Cisatracurium Besylate Solution, 2mg/mL, Intravenous Italy, Italian Drug Agency (AIFA), 044195093 Hikma Canada Limited N/A March 8, 2024 May 15, 2024

Contact Hikma Canada Limited at:
5995 Avebury Road, Suite 804
Mississauga, ON, Canada
L5R 3P9

Colesevelam Hydrochloride Tablets, colesevelam hydrochloride Tablet, 625 mg, oral United States, Food and Drug Administration, National Drug Code (NDC) 68462-433 Glenmark Pharmaceuticals Canada Inc. N/A March 13, 2024 June 30, 2024 Glenmark Pharmaceuticals Canada Inc.
1600 Steeles Avenue West, Suite 407, Concord, Ontario
L4K 4M2
Imunovir, Inosine pranobex Tablet, 500 mg, oral United Kingdom, Medicines and Healthcare products Regulatory Agency, PL 39972/0001 Kora Healthcare Canada Inc N/A May 3, 2024 December 31, 2024 Contact Kora Healthcare Canada at:
1155 North Service Road West, Oakville, Ontario, L6M 3E3
Telephone: 1-778-807-9718
Fax: 1-778-381-5695
Carbamazepine extended release USP, Carbamazepine Tablets, 200 mg, oral United States, Food and Drug Administration, National Drug Code (NDC): 50742-0258-01 Septa Pharmaceuticals Inc. N/A May 31, 2024

December 15,

2024

Contact Septa Pharmaceuticals Inc.; 7035 Maxwell Road, Unit 2

Mississauga, ON L5S 1R5

Carbamazepine extended release USP, Carbamazepine Tablets, 400 mg, oral

United States, Food and Drug Administration, National Drug Code (NDC):

50742-0259-02

Septa Pharmaceuticals Inc. N/A May 31, 2024

December 15,

2024

Contact Septa Pharmaceuticals Inc.; 7035 Maxwell Road, Unit 2

Mississauga, ON L5S 1R5

Chloroprocaine Hydrochloride Injection, USP, Chloroprocaine Hydrochloride, USP Solution, 20 mg/mL, Infiltration United States, Food and Drug Administration, National Drug Code (NDC) 0143-9209-10 Hikma Canada Limited N/A July 29, 2024 December 31, 2024

Contact Hikma Canada Limited at:

5995 Avebury Road, Suite 804
Mississauga, ON
Canada L5R 3P9

Phone: 1-800-656-0793

Marcain – Adrenalin, Bupivacaine hydrochloride and Epinephrine

Solution,

5mg/ml/5mcg/ml, Block/Infiltration, epidural

Denmark, Danish Medicines Agency, 10213 Aspen Pharmacare Canada N/A July 29, 2024 September 30, 2024

Contact Aspen Pharmacare Canada Inc. at:

8 - 1155 North Service Road West,
Oakville, Ontario
L6M 3E3

Telephone: 1-844-330-1213

Epinephrine Injection USP, Epinephrine Solution, 1 mg/10 mL, Intravenous United States of America, Food and Drug Administration, NDC #76329-3318-1 Amphastar Pharmaceuticals, Inc. N/A August 8, 2024 June 30, 2025

Amphastar Pharmaceuticals Inc.

11570 6th Street,
Rancho Cucamonga, California, USA, 91730
Phone: 1-800-423-4136

Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (2 mg/mL), Doxorubicin Hydrochloride

Sterile aqueous suspension, 2 mg/mL, For intravenous infusion only after dilution United States, United States, Food and Drug Administration, National Drug Code (NDC) 47335-049-40 Taro Pharmaceuticals Inc. N/A October 4, 2024 January 31, 2025

Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario
L6T 1C1
Telephone: 905-791-8276 or 1-800-268-1975
Fax: 905-791-5008
E-mail: CustomerServiceCanada@taro.com

Methotrexate for Injection, USP 50mg/ml (Preservative-Free) Lyophilized Powder for Solution, 1 g/Vial, for Intramuscular, Intravenous, Intraarterial or Intrathecal routes. United States of America,
US FDA, 63323-122-50
Fresenius Kabi Canada Ltd. N/A October 17, 2024 January 15, 2025

Contact Fresenius Kabi Canada Inc. at:
Phone: +1 -416-564-5396

or

Address:
165 Galaxy Blvd, Suite 100, Toronto, ON, M9W 0C8

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