Germany· DE-A57-5912416cbf03d77e
Rudotel
A medazepam product containing medazepam, registered in Germany by Teva Gmbh. The same ATC class is registered in 4 of our 19 countries.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
Where it is registered
Medazepam is registered in 4 of 19 countries.
Countries holding a registration under ATC N05BA03 (medazepam), each read from that country’s own register.
- This record: Germany, from EMA Article 57 (European Union)
- 2 of them publish a price we can compare per daily dose
Medazepam · ATC N05BA03
4 / 19 countries
- Finlandprice
- Germany
- Japan
- Polandprice
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Medazepam
- Manufacturer
- Teva Gmbh
- Country
- Germany (DE)
- ATC code
- N05BA03
- ATC class
- Medazepam
- Defined daily dose
- 20 mg, O
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 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.
Same medicine, other countries
Medazepam in 1 other country
What each register calls a product with the same active substance — salts and hydrates count as the same.
Authorised across Europe · EMA
The same active substance is authorised in 4 EEA countries. Names it is sold under:
- Hungary · Medazepam Teva, Rudotel
- Lithuania · Rudotel
- Poland · Medazepam Tzf
- Romania · Medazepam Arena, Medazepam Laropharm
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/95d434d7-c8b0-48c0-b3c5-f5ab14dda62a GET /v1/drugs/95d434d7-c8b0-48c0-b3c5-f5ab14dda62a?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": "Medazepam",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about medazepam.
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.