MYLAN-VALPROIC 250 MG — DIN 02184648
VALPROIC ACID : 250 MG · MYLAN PHARMACEUTICALS ULC · CAPSULE · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is MYLAN-VALPROIC?
MYLAN-VALPROIC 250 MG contains VALPROIC ACID : 250 MG. It is listed in the Health Canada Drug Product Database under DIN 02184648, held by MYLAN PHARMACEUTICALS ULC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 28-Jun-2016. This Drug Identification Number is no longer authorized for sale in Canada, so Nexara does not supply it. The record is kept here because buyers still meet the number on old formularies, purchase orders and tender documents; Nexara can help identify an authorized alternative.
What is MYLAN-VALPROIC used for?
Sole or adjunctive therapy for simple or complex absence seizures (petit mal); useful in primary generalized seizures with tonic-clonic manifestations; adjunctive for multiple seizure types.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Valproic Acid in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
18 holders have a Canadian DIN containing Valproic Acid, across 70 DINs, of which 17 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| APOTEX INC | 10 | 4 | APO-DIVALPROEX, APO-VALPROIC ACID, APO-VALPROIC ACID ORAL SOLUTION, DIVALPROEX, VALPROIC ACID, +1 more | Sourceable in Canada |
| BGP PHARMA ULC | 5 | 4 | DEPAKENE, EPIVAL | Sourceable in Canada |
| MYLAN PHARMACEUTICALS ULC | 7 | 3 | MYL-DIVALPROEX, MYLAN-DIVALPROEX, MYLAN-VALPROIC | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 4 | 3 | JAMP DIVALPROEX, JAMP VALPROIC ACID ORAL SOLUTION | Sourceable in Canada |
| PHARMASCIENCE INC | 6 | 2 | PMS-DIVALPROEX (125MG), PMS-DIVALPROEX (250MG), PMS-DIVALPROEX (500MG), PMS-VALPROIC ACID, PMS-VALPROIC ACID E.C. | Sourceable in Canada |
| ODAN LABORATORIES LTD | 1 | 1 | ODAN-VALPROIC ACID | Sourceable in Canada |
| TEVA CANADA LIMITED | 7 | 0 | NOVO-VALPROIC, RATIO-VALPROIC, TEVA-DIVALPROEX | No marketed DIN |
| DOMINION PHARMACAL | 6 | 0 | DOM-DIVALPROEX, DOM-VALPROIC ACID, DOM-VALPROIC ACID E.C. | No marketed DIN |
| PHARMEL INC | 6 | 0 | PHL-DIVALPROEX, PHL-VALPROIC ACID, PHL-VALPROIC ACID E.C. | No marketed DIN |
| PRO DOC LIMITEE | 4 | 0 | DIVALPROEX-125, DIVALPROEX-250, DIVALPROEX-500, VALPROIC-250 | No marketed DIN |
| RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | 3 | 0 | RATIO-VALPROIC - ECC 500MG, RATIO-VALPROIC 50MG/ML SYRUP, RATIO-VALPROIC-CAP 250MG | No marketed DIN |
| SANIS HEALTH INC | 3 | 0 | DIVALPROEX | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 250 MG |
|---|---|
| Dosage form | CAPSULE |
| Route | ORAL |
| Pack configuration (monograph) | Not explicitly detailed in the provided text beyond the 250 mg capsule strength. |
| Storage | Store at 15-30°C (implied by standard USP/Product Monograph sections, though specific text was truncated in the summary section). |
Pack detail is kept as a regulatory record. This DIN is no longer authorized for sale in Canada, so Nexara does not quote this pack.
Substance and classification
| Active substance | Valproic Acid |
|---|---|
| ATC code | N03AG01 |
| AHFS class | 28:12.92 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02184648 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2184648 |
| Brand name | MYLAN-VALPROIC |
| Generic / active ingredient | VALPROIC ACID : 250 MG |
| Market authorization holder | MYLAN PHARMACEUTICALS ULC |
| Health Canada schedule | Prescription |
| ATC code | N03AG01 |
| ATC anatomical main group | N — Nervous system |
| ATC therapeutic subgroup | N03AG |
| Current status | CANCELLED POST MARKET |
| Status date | 28-Jun-2016 |
| Original market date | 1995-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Initial dose 15 mg/kg/day, increasing at one-week intervals by 5 to 10 mg/kg/day until seizures are controlled or side effects preclude further increases. Maximum recommended dose is 60 mg/kg/day.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hepatic disease/dysfunction; mitochondrial disorders (POLG mutations); known urea cycle disorders; known porphyria; hypersensitivity to the drug or container components.
Warnings and precautions
Serious/fatal hepatotoxicity; life-threatening pancreatitis; teratogenicity; hyperammonemic encephalopathy; suicidal ideation; thrombocytopenia; brain atrophy; rhabdomyolysis.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
17 of 70 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| APO-DIVALPROEX | 250 MG | TABLET (DELAYED-RELEASE) | APOTEX INC | MARKETED | 02239699 |
| APO-DIVALPROEX | 125 MG | TABLET (DELAYED-RELEASE) | APOTEX INC | MARKETED | 02239698 |
| APO-DIVALPROEX | 500 MG | TABLET (DELAYED-RELEASE) | APOTEX INC | MARKETED | 02239700 |
| APO-VALPROIC ACID | 250 MG | CAPSULE | APOTEX INC | MARKETED | 02238048 |
| DEPAKENE | 250 MG / 5 ML | SOLUTION | BGP PHARMA ULC | MARKETED | 00443832 |
| EPIVAL | 500 MG | TABLET (DELAYED-RELEASE) | BGP PHARMA ULC | MARKETED | 00596434 |
| EPIVAL | 250 MG | TABLET (DELAYED-RELEASE) | BGP PHARMA ULC | MARKETED | 00596426 |
| EPIVAL | 125 MG | TABLET (DELAYED-RELEASE) | BGP PHARMA ULC | MARKETED | 00596418 |
| JAMP DIVALPROEX | 250 MG | TABLET (DELAYED-RELEASE) | JAMP PHARMA CORPORATION | MARKETED | 02551152 |
| JAMP DIVALPROEX | 500 MG | TABLET (DELAYED-RELEASE) | JAMP PHARMA CORPORATION | MARKETED | 02551160 |
2 · Same class — other molecules in ATC N03AG
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Valproic Acid | APO-DIVALPROEX · APO-VALPROIC ACID · APO-VALPROIC ACID ORAL SOLUTION · DEPAKENE · +38 more | 70 | 17 | Yes |
| Vigabatrin | SABRIL · SABRIL PWR 1G/SACHET · SABRIL PWR 2G/SACHET · SABRIL PWR 3G/SACHET | 5 | 2 | Yes |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC N03A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| N03AX | Brivaracetam · Cannabidiol · Cenobamate · Lacosamide · Lamotrigine · +4 more | 391 | 197 |
| N03AF | Carbamazepine · Eslicarbazepine · Oxcarbazepine · Rufinamide | 86 | 33 |
| N03AA | Phenobarbital · Primidone | 39 | 13 |
| N03AB | Fosphenytoin · Phenytoin · Phenytoin, Combinations | 17 | 8 |
| N03AE | Clonazepam | 55 | 8 |
| N03AD | Ethosuximide · Mesuximide | 5 | 4 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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. Patients and unlicensed buyers are routed to a partner pharmacy.
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.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
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.