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Ireland· IE-PA-EU/1/19/1362/003-004

Palynziq 20 mg Solution for injection

A pegvaliase product containing pegvaliase, registered in Ireland by Biomarin International Limited. The same ATC class is registered in 10 of our 19 countries.

ATC A16AB19

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedPalynziq 20 mg Solution for injectionATCA16AB19REGISTER NO.IE-PA-EU/1/19/1362/00…PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Pegvaliase is registered in 10 of 19 countries.

Countries holding a registration under ATC A16AB19 (pegvaliase), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 6 of them publish a price we can compare per daily dose

Pegvaliase · ATC A16AB19

10 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Polandprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

HPRA (Ireland)
Active substance
PEGVALIASE
Manufacturer
Biomarin International Limited
Country
Ireland (IE)
ATC code
A16AB19
ATC class
Pegvaliase
Defined daily dose
30 mg, P
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/19/1362/003-004

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

20 interactions on record for pegvaliase.

Graded by severity as the source publishes them — 20 moderate. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Pegvaliase · interactions on record

20 records

  • 20 moderate

Most severe, free to view

  • NaloxegolA06AH03moderate
  • Coagulation factor IX, II, VII and X in combinationB02BD01moderate
  • Coagulation factor VIIIB02BD02moderate
  • Coagulation factor IXB02BD04moderate
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Pegvaliase in 11 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All pegvaliase products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Palynziq
  • Liechtenstein · Palynziq
  • Norway · Palynziq

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of HPRA (Ireland). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/154aa58a-3ba0-4c91-8cff-f0610098571a
GET /v1/drugs/154aa58a-3ba0-4c91-8cff-f0610098571a?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "form": "Solution for injection in pre-filled syringe",
  "routes": [
    "Subcutaneous use"
  ],
  "source": "hpra",
  "atc_all": [
    "A16A",
    "A16AB19"
  ],
  "strength": null,
  "pa_number": "EU/1/19/1362/003-004",
  "substances": [
    "PEGVALIASE"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "03/05/2019",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about pegvaliase.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.