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Ireland· IE-PA-EU/1/08/490/13-16

Pramipexole Teva 0.7 mg tablets

A dopamine agonists product containing pramipexole dihydrochloride monohydrate, registered in Ireland by Teva Pharma B.V..

ATC N04BC

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedPramipexole Teva 0.7 mg tabletsATCN04BCREGISTER NO.IE-PA-EU/1/08/490/13-…PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about pramipexole dihydrochloride monohydrateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

HPRA (Ireland)
Active substance
Pramipexole dihydrochloride monohydrate
Manufacturer
Teva Pharma B.V.
Country
Ireland (IE)
ATC code
N04BC
ATC class
Dopamine agonists
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/08/490/13-16

Regulatory notes

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

Same medicine, other countries

Pramipexole dihydrochloride monohydrate in 16 other countries

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

All pramipexole dihydrochloride monohydrate products

Authorised across Europe · EMA

The same active substance is authorised in 27 EEA countries. Names it is sold under:

  • Austria · Calmolan, Calmolan Retard
  • Belgium · Pramipexol, Pramipexol Eg
  • Bulgaria · Parson, Peximyr 0,18 Mg
  • Cyprus · Medopexol, Rapexole
  • Czechia · Calmolan, Glepark
  • Germany · Glepark, Pexapral
  • Denmark · Glepark, Mariprax
  • Spain · Pramipexol Aurovitas, Pramipexol Aurovitas Spain
  • Finland · Pramipexol, Pramipexol Stada
  • France · Pramipexole Arrow Lab, Pramipexole Biogaran
  • United Kingdom (Northern Ireland) · Pipexus, Pramipexole Glenmark Pharmaceuticals Europe
  • Greece · Glepark, Mariprax
  • Croatia · Pramipeksol Pliva
  • Hungary · Calmolan, Erimexol
  • Iceland · Mirapexin, Oprymea
  • Italy · Pramiperal, Pramipexolo Aurobindo
  • Liechtenstein · Mirapexin, Pramipexole Teva
  • Lithuania · Pramipexole Orion
  • Luxembourg · Pramipexol Eg, Pramipexole Eg
  • Latvia · Pramipexole Elvim, Pramipexole Orion
  • Malta · Pramipexole Aurobindo
  • Netherlands · Glepark, Pramipexol Aurobindo
  • Norway · Mirapexin, Oprymea
  • Portugal · Pramipexol Aurobindo, Pramipexol Azevedos
  • Romania · Pramipexol Arena, Pramipexol Stada
  • Sweden · Calmolan, Derinik
  • Slovakia · Glepark, Pramipexol Stada

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/b13122c9-0b6e-4bb7-8d42-6f4df57e3769
GET /v1/drugs/b13122c9-0b6e-4bb7-8d42-6f4df57e3769?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": "Tablet",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "N04BC"
  ],
  "strength": null,
  "pa_number": "EU/1/08/490/13-16",
  "substances": [
    "Pramipexole dihydrochloride monohydrate"
  ],
  "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": null,
  "dispensing_status": "Product subject to prescription which may be renewed (B)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": "IC0152-184-002"
}
API referenceMCP serverPlans

See everything about pramipexole dihydrochloride monohydrate.

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.

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