Poland· PL-100042260

Medazepam TZF

A medazepam product containing medazepamum, registered in Poland by Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.. The same ATC class is registered in 4 of our 19 countries.

ATC N05BA03

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedMedazepam TZFATCN05BA03REGISTER NO.PL-100042260PACKS LISTED2CHECKEDSeptember 27, 2026

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: Poland, from URPL (Poland)
  • 2 of them publish a price we can compare per daily dose

Medazepam · ATC N05BA03

4 / 19 countries

  • Finlandprice
  • Germany
  • Japan
  • Polandprice
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.

The record

At a glance

URPL (Poland)
Active substance
Medazepamum
Manufacturer
Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
Country
Poland (PL)
ATC code
N05BA03
ATC class
Medazepam
Defined daily dose
20 mg, O
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 2

  • gtin
    05909990136018
  • gtin
    05909990569458

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.

All medazepam products

Authorised across Europe · EMA

The same active substance is authorised in 4 EEA countries. Names it is sold under:

  • Germany · Rudotel
  • Hungary · Medazepam Teva, Rudotel
  • Lithuania · Rudotel
  • 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 URPL (Poland). 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/897bb256-17d1-4089-90da-de15f30bf72c
GET /v1/drugs/897bb256-17d1-4089-90da-de15f30bf72c?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.

{
  "form": "Kapsułki twarde",
  "source": "urpl",
  "strength": "10 mg",
  "packaging": "05909990136018 ¦ Rp ¦ Skasowane ¦ 1310\n20 kaps. w fiolce\n05909990569458 ¦ Rp ¦ 33298\n20 kaps.",
  "substance": "Medazepamum 10 mg",
  "common_name": "Medazepamum",
  "pl_product_id": "100042260",
  "pozwolenie_nr": "01360",
  "auth_procedure": "NAR",
  "authorisation_validity": "Bezterminowe"
}

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.