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France· FR:65265758

DILATRANE 300 mg, gélule à libération prolongée

A medicinal product containing théophylline, registered in France by SERP.

Checked against Base de données publique des médicaments — BDPM (France) on

Informational only — not a medical device.

SOURCE REGISTER · FRBase de données publique des médicament…normalisedDILATRANE 300 mg, gélule à libération…ATC—REGISTER NO.FR:65265758PACKS LISTED1CHECKEDSeptember 12, 2026

The record

At a glance

Base de données publique des médicaments — BDPM (France)
Active substance
THÉOPHYLLINE
Manufacturer
SERP
Country
France (FR)
ATC code
—
Reimbursed
No
Source register
Base de données publique des médicaments — BDPM (France)
Last checked
September 12, 2026

Packs & prices · 1

  • cip13
    3400932787999
    plaquette(s) thermoformée(s) PVC-Aluminium de 30 gélule(s)

Regulatory notes

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

Same medicine, other countries

Théophylline in 13 other countries

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

All théophylline products

Authorised across Europe · EMA

The same active substance is authorised in 25 EEA countries. Names it is sold under:

  • Austria · Theospirex, Theospirex Retard
  • Belgium · Xanthium
  • Bulgaria · Теотард
  • Cyprus · Theo-Dur
  • Czechia · Euphyllin Cr N
  • Germany · Afpred Forte-Theo, Bronchoretard
  • Denmark · Theo-Dur, Unixan
  • Estonia · Teotard
  • Spain · Elixifilin, Teromol Retard
  • Finland · Retafyllin
  • United Kingdom (Northern Ireland) · Uniphyllin
  • Greece · Theo-Bros, Theo-Dur
  • Croatia · Teotard
  • Hungary · Theophyllini Fono Vii. Naturland, Theophyllini Fono Viii. Parma
  • Ireland · Uniphyllin
  • Lithuania · Teotard
  • Luxembourg · Xanthium
  • Latvia · Teotard
  • Norway · Theo-Dur
  • Poland · Euphyllin Long, Theophyllinum Tramco
  • Portugal · Unicontin
  • Romania · Teotard
  • Sweden · Theo-Dur
  • Slovenia · Teotard
  • Slovakia · Euphyllin Cr N 200, Euphyllin Cr N 300

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 Base de données publique des médicaments — BDPM (France). 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/469f8c42-1b33-4f13-8a40-23ac74ccb898
GET /v1/drugs/469f8c42-1b33-4f13-8a40-23ac74ccb898?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.

{
  "cis": "65265758",
  "date_amm": "1985-02-04",
  "type_amm": "Procédure nationale",
  "numero_ue": null,
  "substance": "THÉOPHYLLINE",
  "statut_amm": "Autorisation active",
  "statut_bdm": null,
  "forme_pharmaceutique": "gélule à libération prolongée",
  "voies_administration": "orale",
  "etat_commercialisation": "Commercialisée",
  "surveillance_renforcee": "Non"
}

See everything about théophylline.

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.