Brazil
BRSouth America
Regulatory Overview
Brazil is regulated by the ANVISA. 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
ANVISA
Regulatory Pathways (1)
ANVISA's expanded access program allows use of unapproved drugs for patients with serious or life-threatening diseases who have no therapeutic alternatives among registered products.
Application Form: ANVISA EAP Petition
Legal Basis: RDC 204/2017
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: ANVISA Expanded Access Regulations
Drugs Available (33)
| Drug | Access Route | Status | Lead Time |
|---|---|---|---|
| furosemide | — | — | — |
| tamoxifen citrate | — | — | — |
| metoprolol | — | — | — |
| carbamazepine | — | — | — |
| diethylcarbamazine | — | — | — |
| minoxidil | — | — | — |
| phacoemulsification surgery | — | — | — |
| ascorbic acid | — | — | — |
| Digoxin | — | — | — |
| Retinoids (Tretinoin) | — | — | — |
| Valproic Acid | — | — | — |
| vutrisiran | — | — | — |
| Angiotensin-Converting Enzyme Inhibitors (Enalapril) | — | — | — |
| ivermectin | — | — | — |
| rituximab | — | — | — |
| allopurinol | — | — | — |
| Topical corticosteroids | — | — | — |
| Erythromycin | — | — | — |
| avalglucosidase alfa | — | — | — |
| Methotrexate | — | — | — |
| Levetiracetam | — | — | — |
| prednisone | — | — | — |
| aflibercept | — | — | — |
| riboflavin | — | — | — |
| bevacizumab | — | — | — |
| celecoxib | — | — | — |
| Biotin | — | — | — |
| Zidovudine | — | — | — |
| emollients with keratolytics | — | — | — |
| Tamoxifen | — | — | — |
| Artificial tears (Hypromellose) | — | — | — |
| Ribavirin | — | — | — |
| Amnioreduction | — | — | — |
Brazil
| ISO Code | BR |
| Region | South America |
| Regulatory Authority | ANVISA |
| Pathways | 1 documented |
| Drugs Available | 33 drug(s) |