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ARCHIVED 1. List of drugs for exceptional importation and sale [2024-05-14 to 2024-05-27] - Canada.ca
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ARCHIVED 1. List of drugs for exceptional importation and sale [2024-05-14 to 2024-05-27]
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:
Drug shortages regulations and guidance
Guide to the exceptional importation and sale of drugs in response to drug shortages
Supercedes:
2024-05-07
Date issued:
2024-05-14
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
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
July 8, 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
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
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
September 30, 2024
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
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
June 30, 2024
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, 2024
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
September 27, 2022
January 1, 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
June 30, 2024
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, 2023
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, 2024
Contact Amphastar Pharmaceuticals Inc. at:
11570 6
th
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
Page details
Date modified:
2024-05-29