Sweden· SE-20120801000161
Calmolan 1,57 mg Depottablett
A medicinal product containing pramipexole dihydrochloride monohydrate, registered in Sweden by G.L. Pharma GmbH.
Checked against Swedish Medical Products Agency (Sweden) on
Informational only — not a medical device.
The record
At a glance
Swedish Medical Products Agency (Sweden)- Active substance
- Pramipexole Dihydrochloride Monohydrate
- Manufacturer
- G.L. Pharma GmbH
- Country
- Sweden (SE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- Swedish Medical Products Agency (Sweden)
- Last checked
- October 1, 2026
Packs & prices · 1
- se_varunummer20120801000161
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 1.57mg modified-release tabletsBoehringer Ingelheim Ltd
- CzechiaMIRAPEXINBoehringer Ingelheim International GmbH, Ingelheim am Rhein
- FinlandMirapexinBoehringer Ingelheim International GmbH
- BelgiumMirapexin 1.57 mgBoehringer Ingelheim International
- NetherlandsMirapexin 1,57 mg, tabletten met verlengde afgifteBoehringer Ingelheim International GmbH
- IcelandMirapexinBoehringer Ingelheim International GmbH*
- SpainOprymea 1,57 mg comprimidos de liberacion prolongada EFGKrka D.D. Novo Mesto
- PolandMirapexinBoehringer 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
- Ireland · Miramel
- 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
- 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 Swedish Medical Products Agency (Sweden). 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/47386e19-a8f3-4a54-8b79-aaa31b8da14f GET /v1/drugs/47386e19-a8f3-4a54-8b79-aaa31b8da14f?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.
{
"source": "lakemedelsverket",
"doc_types": [
"SmPC",
"PL",
"PAR",
"sPAR"
],
"se_npl_id": "20120801000161",
"product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20120801000161",
"product_doc_link": "https://docetp.mpa.se/LMF/Calmolan%20prolonged-release%20tablet%20SmPC_09001bee807a0a78.pdf"
}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.