BALVERSA 4 MG
ERDAFITINIB : 4 MG · DIN 02493225 · JANSSEN INC
Health Canada status: MARKETED
What is BALVERSA?
BALVERSA 4 MG contains ERDAFITINIB : 4 MG. It is listed in the Health Canada Drug Product Database under DIN 02493225, held by JANSSEN INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 09-Dec-2019. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is BALVERSA used for?
BALVERSA (erdafitinib) is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor (FGFR) 3 genetic alterations, who have disease progression during or following at least one line of prior therapy including within 12 months of neoadjuvant or adjuvant therapy. BALVERSA should not be used for the treatment of patients who are eligible for and have not received prior programmed death receptor-1 (PD-1) or programmed death-ligand 1(PD-L1) inhibitor therapy.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02493225 |
|---|---|
| Brand name | BALVERSA |
| Generic / active ingredient | ERDAFITINIB : 4 MG |
| Manufacturer | JANSSEN INC |
| Strength | 4 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | L01EN01 ERDAFITINIB |
| AHFS class | 10:00.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 09-Dec-2019 |
| Original market date | 2019-12-09 00:00:00 |
How is it stored and handled?
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How is it supplied?
• 3 mg tablets: • Bottle of 56-tablets [28 days supply of 6 mg daily dose] • Bottle of 84-tablets [28 days supply of 9 mg daily dose] • Blister packs of 28 tablets, two blisters per box (56 tablets total) [28 days supply of 6 mg daily dose] • Blister packs of 42 tablets, two blisters per box (84 tablets total) [28 days supply of 9 mg daily dose] • 4 mg tablets: • Bottle of 28-tablets [28 days supply of 4 mg daily dose] • Bottle of 56-tablets [28 days supply of 8 mg daily dose] • Blister pack of 14 tablets (Starter pack) [7 days supply of 8 mg daily dose] • Blister pack of 28 tablets [28 days supply of 4 mg daily dose] • Blister packs of 28 tablets, two blisters per box (56 tablets total) [28 days supply of 8 mg daily dose] • 5 mg tablets: • Bottle of 28-tablets [28 days supply of 5 mg daily dose] • Blister pack of 28 tablets [28 days supply of 5 mg daily dose]
What can be used instead?
Other Canadian products sharing ATC code L01EN01 ERDAFITINIB. 3 of 4 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| BALVERSA | 3 MG | TABLET | JANSSEN INC | MARKETED | DIN 02493217 |
| BALVERSA | 5 MG | TABLET | JANSSEN INC | MARKETED | DIN 02493233 |
| BALVERSA | 4 MG | TABLET | JANSSEN INC | APPROVED | DIN 02493241 |
Who else supplies ERDAFITINIB worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. ERDAFITINIB appears in 26 registered pack listings across 6 markets, published on 5 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.