RADICAVA 105 MG / 5 ML
EDARAVONE 105 MG · DIN 02532611 · MITSUBISHI TANABE PHARMA CORPORATION
Health Canada status: MARKETED
What is RADICAVA?
RADICAVA 105 MG / 5 ML contains EDARAVONE 105 MG. It is listed in the Health Canada Drug Product Database under DIN 02532611, held by MITSUBISHI TANABE PHARMA CORPORATION, supplied as Suspension for Oral administration. Health Canada currently lists it as marketed, status dated 29-Jun-2026. 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 RADICAVA used for?
RADICAVA is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).
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 | 02532611 |
|---|---|
| Brand name | RADICAVA |
| Generic / active ingredient | EDARAVONE 105 MG |
| Manufacturer | MITSUBISHI TANABE PHARMA CORPORATION |
| Strength | 105 MG / 5 ML |
| Dosage form | Suspension |
| Route of administration | Oral |
| Schedule | PRESCRIPTION |
| ATC code | N07XX14 EDARAVONE |
| AHFS class | 80:12.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 29-Jun-2026 |
How is it administered?
The recommended dose of RADICAVA (oral suspension) is 105 mg (5 mL) taken orally or via a feeding tube [Nasogastric (NG) tube or Percutaneous Endoscopic Gastrostomy (PEG) tube) according to the following schedule: • An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug-free period • Subsequent treatment cycles with daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods. RADICAVA (oral suspension) should be taken in the morning after fasting overnight for at least 8 hours and waiting at least 1 hour before eating or drinking anything except water. For patients who are unable to fast overnight, the required fasting interval can be shortened depending on the type of meal (see Table 1 for specific fasting conditions, and see 10 CLINICAL PHARMACOLOGY and PATIENT MEDICATION INFORMATION, How to take RADICAVA (oral suspension).
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Pharmacy: Store RADICAVA (oral suspension) refrigerated between 2°C – 8°C and protect from light. Do not freeze. Store upright. Patient: Store RADICAVA (oral suspension) upright at room temperature between 20°C-25°C. Protect from light. Dispose of any RADICAVA (oral suspension) that is not used within 15 days after opening the bottle or within the 30 days (if unopened) from the date of shipment indicated on the carton label, whichever happens first.
How is it supplied?
RADICAVA (oral suspension) is a white to off-white suspension in a multi-dose child resistant 60 mL amber glass bottle which is supplied as two configurations: RADICAVA (oral suspension) Starter Kit: Carton of two (2) inner cartons, each containing of one (1) bottle of 35 mL (105 mg/5 mL dose), two (2) oral dosing syringes and one bottle adapter. RADICAVA (oral suspension) Kit: One carton of one (1) bottle of 50 mL (105 mg/5 ml dose), two (2) oral dosing syringes and one (1) bottle adapter.
Contraindications
Edaravone is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity Reactions). For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Warnings and precautions
Hypersensitivity reactions (redness, wheals and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure and dyspnea) have been reported in spontaneous post marketing reports with RADICAVA (injection). Based on the spontaneous post marketing reports, it appears RADICAVA (injection) can cause anaphylactic reactions. Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA (injection)/ RADICAVA (oral suspension), treat per standard of care and monitor until the condition resolves. (see 2 CONTRAINDICATIONS). Sulfite Allergic Reactions: RADICAVA (injection) / RADICAVA (oral suspension) contain sodium bisulfite, a sulfite that may cause allergic type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown. Sulfite sensitivity occurs more frequently in people with asthma. Skin: A higher incidence of skin-related adverse events was identified in RADICAVA (injection)-patients compared to placebo patients in pooled placebo-controlled clinical trials (26% RADICAVA; 19% placebo), including eczema (7% RADICAVA; 2% placebo), dermatitis contact (6% RADICAVA; 3% placebo), rash (4% RADICAVA; 2% placebo), and erythema (3% RADICAVA; 2% placebo). There was also one case of toxic skin eruption on RADICAVA (injection). Based on the clinical trial reports, it appears RADICAVA (injection) can cause skin reactions.
What can be used instead?
Other Canadian products sharing ATC code N07XX14 EDARAVONE. 1 of 2 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 |
|---|---|---|---|---|---|
| RADICAVA | 30 MG / 100 ML | SOLUTION | MITSUBISHI TANABE PHARMA CORPORATION | CANCELLED POST MARKET | DIN 02475472 |
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.