OrphanDrug
OrphanDrug
Pharma Knowledge Base
CA

Canada

CA

North America

Contents

  1. 1. Regulatory Overview
  2. 2. Regulatory Pathways
  3. 3. Available Drugs

Regulatory Overview

Canada is regulated by the Health Canada. The country has 1 documented regulatory pathway for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.

Regulatory Authority

Health Canada

Regulatory Pathways (1)

Health Canada Special Access Program (SAP) 5 days

Health Canada's SAP allows manufacturers to sell drugs not approved in Canada to practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable.

Application Form: HC/SC 3011 SAP Request Form
Legal Basis: Section C.08.010 Food and Drug Regulations
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: Health Canada SAP Guidance

Drugs Available (196)

DrugAccess RouteStatusLead Time
alglucosidase alfa———
cytarabine———
eliglustat———
vitamin A (retinol)———
furosemide———
eribulin mesylate———
Digoxin Immune Fab———
Sucralfate———
Dorzolamide———
Pravastatin———
Temsirolimus———
naproxen———
Memantine———
propranolol———
tamoxifen citrate———
atropine sulfate———
metoprolol———
carbamazepine———
ruxolitinib———
Melphalan———
mycophenolate mofetil———
Epoprostenol———
Sodium Phenylbutyrate———
etanercept———
Denosumab———
dapsone———
Tofacitinib———
mavacamten———
minoxidil———
ibuprofen———
gabapentin———
Hydroxychloroquine———
cyclophosphamide———
Anakinra———
bosentan———
bimatoprost———
testosterone———
Artificial tears———
Rho(D) immune globulin———
Baclofen———
Dexrazoxane———
Vigabatrin———
Clobazam———
phacoemulsification surgery———
melatonin———
amiodarone———
Total Parenteral Nutrition———
Growth hormone (somatropin)———
ascorbic acid———
hormone replacement therapy (estrogen/progesterone)———
Busulfan———
Digoxin———
Romidepsin———
Interferon gamma-1b———
collagenase clostridium histolyticum———
physical therapy and orthotic management———
Retinoids (Tretinoin)———
eculizumab———
miglustat———
Betaine anhydrous———
tizanidine———
Octreotide———
aspirin———
oxybutynin———
Valproic Acid———
tocilizumab———
sclerostin antibody———
Immunoglobulin———
Mesalamine———
alpha-L-iduronidase———
Intravenous Immunoglobulin (IVIG)———
Phenytoin———
Bisphosphonates (pamidronate)———
Metronidazole———
Nitisinone———
Human Chorionic Gonadotropin (hCG)———
treprostinil———
sirolimus———
temozolomide———
Carnitine———
brivaracetam———
Infliximab———
folic acid———
Pyridoxine———
Acetazolamide———
Clomiphene Citrate———
Angiotensin-Converting Enzyme Inhibitors (Enalapril)———
Multivitamin with Calcium and Vitamin D———
levothyroxine sodium———
botulinum toxin type A———
Levothyroxine———
mexiletine———
azathioprine———
sunscreen (broad spectrum SPF 50+)———
galantamine———
ambrisentan———
Brentuximab vedotin———
L-carnitine———
insulin———
luspatercept———
trabectedin———
eplontersen———
prednisolone———
Tegaserod———
rituximab———
Dapagliflozin———
allopurinol———
Carboplatin———
Topical corticosteroids———
estradiol———
Erythromycin———
Doxycycline———
calcium carbonate———
coenzyme Q10———
Patisiran———
Tolvaptan———
cerliponase alfa———
belumosudil———
adalimumab———
Imiglucerase———
Amphotericin B liposomal———
ranibizumab———
metformin———
Methotrexate———
carglumic acid———
Alendronate Sodium———
calcitriol———
doxorubicin———
Pyridostigmine———
Levetiracetam———
Acitretin———
prednisone———
salicylic acid———
Insulin glargine———
cochlear implant———
Pyridostigmine Bromide———
aflibercept———
laronidase———
Romiplostim———
Bleomycin———
hydroxycobalamin———
Laser photocoagulation therapy———
acetaminophen———
pregabalin———
riboflavin———
N-acetylcysteine———
Occupational and Physical Therapy Support———
eptinezumab———
Pamidronate———
nitroglycerin———
Sacrosidase———
ezetimibe———
Belzutifan———
atorvastatin———
bevacizumab———
proton pump inhibitors (omeprazole)———
mecasermin———
celecoxib———
Biotin———
Imiquimod———
cyclosporine ophthalmic———
Growth Hormone———
deferasirox———
Diatrizoate———
Tafamidis———
urea———
Levodopa/Carbidopa———
Lanreotide———
cyanocobalamin———
Sodium Bicarbonate———
diazoxide———
baricitinib———
Zoledronic Acid———
Hypertonic saline———
Clonazepam———
Zidovudine———
emollients with keratolytics———
warfarin———
Vitamin K1 (Phytonadione)———
cornstarch———
disopyramide———
Sunitinib———
Cisplatin———
imatinib mesylate———
nimodipine———
Colchicine———
surgical repair———
Tamoxifen———
Artificial tears (Hypromellose)———
vitamin D3———
Sildenafil———
sotalol———
Hematopoietic stem cell transplantation———
Diazepam———
Timolol maleate———
Amnioreduction———
CA
Canada
ISO CodeCA
RegionNorth America
Regulatory AuthorityHealth Canada
Pathways1 documented
Drugs Available196 drug(s)