Ireland· IE-PA-EU/1/08/490/9-12
Pramipexole Teva 0.35 mg tablets
A dopamine agonists product containing pramipexole dihydrochloride monohydrate, registered in Ireland by Teva Pharma B.V..
Checked against HPRA (Ireland) on
Informational only — not a medical device.
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_numberEU/1/08/490/9-12
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.
- United KingdomMirapexin 0.35mg tabletsBoehringer Ingelheim Ltd
- FinlandDerinikActavis Group PTC ehf
- CzechiaMIRAPEXINBoehringer Ingelheim International GmbH, Ingelheim am Rhein
- SwedenDerinik 0,35 mg TablettActavis Group PTC ehf.
- NetherlandsGlepark 0,35 mg tablettenGlenmark Arzneimittel GmbH
- IcelandMirapexinBoehringer Ingelheim International GmbH*
- PolandMirapexinBoehringer Ingelheim International GmbH
- SpainMIRAPEXIN 0,35 mg COMPRIMIDOSBoehringer Ingelheim International Gmbh
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/c4c337c0-c5ce-4a91-b7bf-2a0d426d0437 GET /v1/drugs/c4c337c0-c5ce-4a91-b7bf-2a0d426d0437?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/1/08/490/9-12",
"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": "IC0152-183-002"
}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.