Poland· PL-100047850

NO-SPA ampułki

A drotaverine product containing drotaverini hydrochloridum, registered in Poland by Opella Healthcare Commercial Ltd.. The same ATC class is registered in 3 of our 19 countries.

ATC A03AD02

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedNO-SPA ampułkiATCA03AD02REGISTER NO.PL-100047850PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Drotaverine is registered in 3 of 19 countries.

Countries holding a registration under ATC A03AD02 (drotaverine), each read from that country’s own register.

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

Drotaverine · ATC A03AD02

3 / 19 countries

  • Czechiaprice
  • 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.

The record

At a glance

URPL (Poland)
Active substance
Drotaverini hydrochloridum
Manufacturer
Opella Healthcare Commercial Ltd.
Country
Poland (PL)
ATC code
A03AD02
ATC class
Drotaverine
Defined daily dose
0.1 g, O
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 2

  • gtin
    05909990030712
  • gtin
    05909991134839

Regulatory notes

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

Same medicine, other countries

Drotaverine in 2 other countries

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

All drotaverine products

Authorised across Europe · EMA

The same active substance is authorised in 9 EEA countries. Names it is sold under:

  • Bulgaria · Dro Spaz, Дро Спаз
  • Czechia · No-Spa
  • Estonia · No-Spa
  • Hungary · Drotavep, Drotavep Forte
  • Lithuania · No-Spa, No-Spa Forte
  • Latvia · No-Spa, No-Spa Forte
  • Malta · No-Spa, No-Spa Forte
  • Romania · Antispasmin, Antispasmin Forte
  • Slovakia · No-Spa, No-Spa Forte

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/dbecd858-c0c9-4a87-99a0-be4bd2bcb641
GET /v1/drugs/dbecd858-c0c9-4a87-99a0-be4bd2bcb641?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": "Roztwór do wstrzykiwań",
  "source": "urpl",
  "strength": "20 mg/ml",
  "packaging": "05909990030712 ¦ Rp ¦ 7147\n5 amp. 2 ml\n05909991134839 ¦ Rp ¦ 90804\n25 amp. 2 ml",
  "substance": "Drotaverini hydrochloridum 40 mg",
  "common_name": "Drotaverini hydrochloridum",
  "pl_product_id": "100047850",
  "pozwolenie_nr": "00307",
  "auth_procedure": "NAR",
  "authorisation_validity": "Bezterminowe"
}

See everything about drotaverine.

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.