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Germany· DE-A57-a492567709db17a9

Tolperison-Hcl Dura

A tolperisone product containing tolperisone hydrochloride, registered in Germany by Mylan Germany Gmbh. The same ATC class is registered in 7 of our 19 countries.

ATC M03BX04

Checked against EMA Article 57 (European Union) on

Informational only — not a medical device.

SOURCE REGISTER · DEEMA Article 57 (European Union)normalisedTolperison-Hcl DuraATCM03BX04REGISTER NO.DE-A57-a492567709db17…PACKS LISTED0CHECKEDJuly 8, 2026

Where it is registered

Tolperisone is registered in 7 of 19 countries.

Countries holding a registration under ATC M03BX04 (tolperisone), each read from that country’s own register.

  • This record: Germany, from EMA Article 57 (European Union)
  • 4 of them publish a price we can compare per daily dose

Tolperisone · ATC M03BX04

7 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Germany
  • Ireland
  • Netherlands
  • Polandprice
  • Switzerlandprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of tolperisone costs, country by country.

Normalised to the WHO defined daily dose (0.2 g), so markets compare like for like.

  • 1 market with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Tolperisone · price per daily dose (0.2 g)

USD · FX 28 Sept 2026

  • CH Switzerland$1.33
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

EMA Article 57 (European Union)
Active substance
Tolperisone Hydrochloride
Manufacturer
Mylan Germany Gmbh
Country
Germany (DE)
ATC code
M03BX04
ATC class
Tolperisone
Defined daily dose
0.2 g, O
Reimbursed
Not published by this register
Source register
EMA Article 57 (European Union)
Last checked
July 8, 2026

Packs & prices · 0

No packs listed by the register for this record.

Regulatory notes

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

Interactions

1 interaction on record for tolperisone.

Mechanism, severity and management for each pair, from a commercially licensed source — included with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Tolperisone · interactions on record

1 record

1 more interaction with mechanism and management, from a commercially licensed source.

Sign in to check
Mechanism and what to do, in the interaction check
Interaction register. Grades as the source publishes them.

Same medicine, other countries

Tolperisone in 5 other countries

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

All tolperisone products

Authorised across Europe · EMA

The same active substance is authorised in 10 EEA countries. Names it is sold under:

  • Bulgaria · Мидокалм, Толкимадо
  • Cyprus · Mydoflex
  • Czechia · Mydocalm
  • Hungary · Flexirizon, Meditolp
  • Lithuania · Mydocalm
  • Latvia · Mydocalm
  • Netherlands · Tolpermyo
  • Poland · Mydocalm, Mydocalm Forte
  • Romania · Myderison, Mydocalm
  • Slovakia · Mydocalm

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 EMA Article 57 (European Union). 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/d9a9592e-66e9-461b-914a-4dc6cafdb747
GET /v1/drugs/d9a9592e-66e9-461b-914a-4dc6cafdb747?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.

{
  "pzn": null,
  "route": "Oral Use",
  "source": "ema_art57_de",
  "ma_number": null,
  "substance": "Tolperisone Hydrochloride",
  "atc_from_source": null,
  "authorisation_country": "Germany"
}

See everything about tolperisone.

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.