France· FR:61089729
GABITRIL 15 mg, comprimé pelliculé
A medicinal product containing tiagabine (chlorhydrate de) monohydraté, registered in France by TEVA PHARMA (PAYS-BAS), on the national reimbursement list.
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- TIAGABINE (CHLORHYDRATE DE) MONOHYDRATÉ
- Manufacturer
- TEVA PHARMA (PAYS-BAS)
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- Yes
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
1 priced- cip1334009341264821 flacon(s) polyéthylène haute densité (PEHD) de 50 comprimé(s) avec fermeture de sécurité enfantEUR 73.11
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tiagabine (chlorhydrate de) monohydraté in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumGabitril 15 mgTeva
- SpainGABITRIL 15 mg COMPRIMIDOS RECUBIERTOS CON PELICULATeva B.V.
- FinlandGabitrilCephalon France
- IrelandGabitril 15 mg film-coated tabletsTeva Pharma B.V.
- PolandGabitrilTeva Pharmaceuticals Polska Sp. z o.o.
- United KingdomGabitril 10mg tabletsTeva UK Ltd
- United StatesTiagabine HydrochlorideNovadoz Pharmaceuticals LLC
- ItalyGABITRIL*50 cpr rivestite 10 mgTEVA ITALIA Srl
Authorised across Europe · EMA
The same active substance is authorised in 8 EEA countries. Names it is sold under:
- Belgium · Gabitril
- Spain · Gabitril
- United Kingdom (Northern Ireland) · Gabitril
- Ireland · Gabitril
- Italy · Gabitril
- Luxembourg · Gabitril
- Poland · Gabitril
- Portugal · Gabitril
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/d133d514-df43-4097-9d01-a5765a36a82e GET /v1/drugs/d133d514-df43-4097-9d01-a5765a36a82e?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": "61089729",
"date_amm": "1996-06-14",
"type_amm": "Procédure de reconnaissance mutuelle",
"numero_ue": null,
"substance": "TIAGABINE (CHLORHYDRATE DE) MONOHYDRATÉ",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "comprimé pelliculé",
"voies_administration": "orale",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Non"
}See everything about tiagabine (chlorhydrate de) monohydraté.
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.