APO-ROPINIROLE 0.5 MG
ROPINIROLE (ROPINIROLE HYDROCHLORIDE) : 0.5 MG · DIN 02337754 · APOTEX INC
Health Canada status: APPROVED
What is APO-ROPINIROLE?
APO-ROPINIROLE 0.5 MG contains ROPINIROLE (ROPINIROLE HYDROCHLORIDE) : 0.5 MG. It is listed in the Health Canada Drug Product Database under DIN 02337754, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as approved, status dated 04-Dec-2009. 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 APO-ROPINIROLE used for?
Treatment of the signs and symptoms of idiopathic Parkinson's disease. Can be used as early therapy or as an adjunct to levodopa.
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 | 02337754 |
|---|---|
| Brand name | APO-ROPINIROLE |
| Generic / active ingredient | ROPINIROLE (ROPINIROLE HYDROCHLORIDE) : 0.5 MG |
| Manufacturer | APOTEX INC |
| Strength | 0.5 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | N04BC04 ROPINIROLE |
| AHFS class | 28:36.20.08 |
| Biosimilar | No |
| Health Canada status | APPROVED |
| Status date | 04-Dec-2009 |
How is it administered?
Titrate dose to clinical response. Early therapy: start 0.25 mg t.i.d. Adjunct therapy: start 0.25 mg t.i.d.; may require reduction in levodopa dose. Max dose 24 mg/day.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (refers to STORAGE AND STABILITY section).
How is it supplied?
Not explicitly detailed in provided text (refers to DOSAGE FORMS, COMPOSITION AND PACKAGING section).
Contraindications
Known hypersensitivity to ropinirole hydrochloride or any excipients in the drug product.
Warnings and precautions
Sudden onset of sleep without warning; orthostatic hypotension; impulse control disorders (gambling, hypersexuality); hallucinations; dyskinesia; potential for melanoma risk.
What can be used instead?
Other Canadian products sharing ATC code N04BC04 ROPINIROLE. 8 of 52 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 |
|---|---|---|---|---|---|
| SPC-ROPINIROLE | 0.25 MG | TABLET | SUN PHARMA CANADA INC | MARKETED | DIN 02314037 |
| SPC-ROPINIROLE | 1 MG | TABLET | SUN PHARMA CANADA INC | MARKETED | DIN 02314053 |
| SPC-ROPINIROLE | 2 MG | TABLET | SUN PHARMA CANADA INC | MARKETED | DIN 02314061 |
| SPC-ROPINIROLE | 5 MG | TABLET | SUN PHARMA CANADA INC | MARKETED | DIN 02314088 |
| TEVA-ROPINIROLE | 0.25 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02316846 |
| TEVA-ROPINIROLE | 1 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02316854 |
| TEVA-ROPINIROLE | 2 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02316862 |
| TEVA-ROPINIROLE | 5 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02316870 |
| APO-ROPINIROLE | 0.25 MG | TABLET | APOTEX INC | APPROVED | DIN 02337746 |
| APO-ROPINIROLE | 1.0 MG | TABLET | APOTEX INC | APPROVED | DIN 02337762 |
Who else supplies ROPINIROLE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. ROPINIROLE appears in 2786 registered pack listings across 9 markets, published on 8 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?
This product is approved by Health Canada but not yet marketed in Canada, so there is no Canadian supply to draw on today. Nexara can tell you whether it has been launched, and can look at supply from other markets where a Canadian pack is not required or where importation is 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.