France· FR:67432729
SIFROL 0,52 mg, comprimé à libération prolongée
A medicinal product containing pramipexole (dichlorhydrate de) monohydraté, registered in France by BOEHRINGER INGELHEIM INTERNATIONAL, on the national reimbursement list.
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- PRAMIPEXOLE (DICHLORHYDRATE DE) MONOHYDRATÉ
- Manufacturer
- BOEHRINGER INGELHEIM INTERNATIONAL
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- Yes
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
1 priced- cip133400939749556plaquette(s) thermoformée(s) polyamide aluminium PVC de 30 comprimé(s)EUR 6.96
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Pramipexole (dichlorhydrate de) monohydraté in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaCALMOLANG.L. Pharma GmbH, Lannach
- United KingdomMirapexin 0.52mg modified-release tabletsLexon (UK) Ltd
- SwedenCalmolan 0,52 mg DepottablettG.L. Pharma GmbH
- ItalyMIRAPEXINBOEHRINGER INGELHEIM INTERNATIONAL GMBH
- FinlandMirapexinBoehringer Ingelheim International GmbH
- BelgiumMirapexin 0.52 mgBoehringer Ingelheim International
- IcelandMirapexinBoehringer Ingelheim International GmbH*
- IrelandMIRAPEXIN 0.52 mg prolonged-release tabletsBoehringer 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
- 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
- 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 Base de données publique des médicaments — BDPM (France). 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/ac4c40bf-832c-4b2e-93ac-234850392c7a GET /v1/drugs/ac4c40bf-832c-4b2e-93ac-234850392c7a?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.
{
"cis": "67432729",
"date_amm": "2009-10-08",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/97/050",
"substance": "PRAMIPEXOLE (DICHLORHYDRATE DE) MONOHYDRATÉ",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "comprimé à libération prolongée",
"voies_administration": "orale",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Non"
}See everything about pramipexole (dichlorhydrate de) monohydraté.
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.