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Sweden· SE-20081209000194

SIFROL 2,1 mg Depottablett

A medicinal product containing pramipexole dihydrochloride monohydrate, registered in Sweden by Boehringer Ingelheim International GmbH.

Checked against Swedish Medical Products Agency (Sweden) on

Informational only — not a medical device.

SOURCE REGISTER · SESwedish Medical Products Agency (Sweden)normalisedSIFROL 2,1 mg DepottablettATC—REGISTER NO.SE-20081209000194PACKS LISTED1CHECKEDOctober 1, 2026

The record

At a glance

Swedish Medical Products Agency (Sweden)
Active substance
Pramipexole Dihydrochloride Monohydrate
Manufacturer
Boehringer Ingelheim International 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_varunummer
    20081209000194

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
  • 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/bcba08b0-b419-4917-a838-8f11303a6411
GET /v1/drugs/bcba08b0-b419-4917-a838-8f11303a6411?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": [
    "EPAR",
    "EMA"
  ],
  "se_npl_id": "20081209000194",
  "product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20081209000194",
  "product_doc_link": "https://www.ema.europa.eu/sv/documents/product-information/sifrol-epar-product-information_sv.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.