PALYNZIQ 10 MG / 0.5 ML — DIN 02526255
PEGVALIASE : 10 MG / 0.5 ML · BIOMARIN INTERNATIONAL LIMITED · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is PALYNZIQ?
PALYNZIQ 10 MG / 0.5 ML contains PEGVALIASE : 10 MG / 0.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02526255, held by BIOMARIN INTERNATIONAL LIMITED, supplied as SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 26-Aug-2022. 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 PALYNZIQ used for?
To reduce blood phenylalanine concentrations in patients with phenylketonuria (PKU) aged 16 years and older with inadequate control (> 600 micromol/L) despite dietary management.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Pegvaliase cost around the world?
Pegvaliase is listed on 4 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Brazil publishes a preco fabrica (ex-factory ceiling); Italy publishes a ex-factory (classe H); Luxembourg publishes a reimbursement. Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed | Range |
|---|---|---|---|---|
| Luxembourg | reimbursement | 4 | 4 | EUR███.██ |
| Brazil | preco fabrica (ex-factory ceiling) | 1 | 3 | BRL███.██ |
| Italy | ex-factory (classe H) | 3 | 3 | EUR███.██ |
| Norway | max AUP (pharmacy retail) | 1 | 3 | NOK███.██ |
13 pack listings across 9 brand entries and 4 price bases, refreshed 07 Sep 2026. Ranges span every Pegvaliase pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
Is there a generic Pegvaliase 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.
Only one market authorization holder has a Canadian DIN containing Pegvaliase — 3 DINs, of which 3 are currently marketed. There is no second Canadian source today, so a supply interruption on this holder has no domestic substitute at the same molecule.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| BIOMARIN INTERNATIONAL LIMITED | 3 | 3 | PALYNZIQ | Sourceable in Canada |
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 | 10 MG / 0.5 ML |
|---|---|
| Dosage form | SOLUTION |
| Route | SUBCUTANEOUS |
| Pack configuration (monograph) | 2.5 mg, 10 mg, or 20 mg pre-filled syringes. Available in cartons of 1 or 10 (for 20 mg strength). |
| Storage | Not explicitly detailed in provided text snippet (section 11 mentioned but content not shown), though typically refrigerated for biologics. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation, because this listing covers more than one of them.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Substance and classification
| Active substance | Pegvaliase |
|---|---|
| ATC code | A16AB19 |
| AHFS class | 44:00.00 |
| 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) | 02526255 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2526255 |
| Brand name | PALYNZIQ |
| Generic / active ingredient | PEGVALIASE : 10 MG / 0.5 ML |
| Market authorization holder | BIOMARIN INTERNATIONAL LIMITED |
| Health Canada schedule | Prescription |
| ATC code | A16AB19 |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A16AB |
| Current status | MARKETED |
| Status date | 26-Aug-2022 |
| Original market date | 2022-08-26 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Induction: 2.5 mg once weekly for 4 weeks. Titrate gradually to maintenance (20 mg, 40 mg, or 60 mg daily) to achieve blood Phe ≤ 600 micromol/L. Premedication required during induction/titration.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Severe systemic hypersensitivity or recurrent mild-to-moderate anaphylaxis to Palynziq or its ingredients; anaphylaxis to PEG or PEGylated products.
Warnings and precautions
Serious risk of systemic hypersensitivity/anaphylaxis; requires auto-injectable epinephrine, initial supervision by health professional, and a trained observer for first 6 months.
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
3 of 3 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| PALYNZIQ | 2.5 MG / 0.5 ML | SOLUTION | BIOMARIN INTERNATIONAL LIMITED | MARKETED | 02526247 |
| PALYNZIQ | 20 MG | SOLUTION | BIOMARIN INTERNATIONAL LIMITED | MARKETED | 02526263 |
2 · Same class — other molecules in ATC A16AB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Asfotase Alfa | STRENSIQ | 5 | 4 | Yes |
| Pegvaliase | PALYNZIQ | 3 | 3 | Yes |
| Agalsidase Beta | FABRAZYME | 2 | 2 | Yes |
| Imiglucerase | CEREZYME | 2 | 1 | Yes |
| Olipudase Alfa | XENPOZYME | 2 | 1 | Yes |
| Elosulfase Alfa | VIMIZIM | 1 | 1 | Yes |
| Galsufase | NAGLAZYME | 1 | 1 | Yes |
| Idursulfase | ELAPRASE | 1 | 1 | Yes |
| Laronidase | ALDURAZYME | 1 | 1 | Yes |
| Sebelipase Alfa | KANUMA | 1 | 1 | 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 A16A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| A16AX | Anethole Trithione · Eliglustat · Givosiran · Glycerol Phenylbutyrate · Lumasiran · +11 more | 39 | 28 |
| A16AA | Betaine · Carglumic Acid · Levocarnitine · Mercaptamine · Metreleptin | 11 | 11 |
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.
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. 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.