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Belgium· BE-AMP-SAM118517-00

Valtran 50 mg - 4 mg

A tilidine product containing naloxone hydrochloride dihydrate, registered in Belgium by Pfizer.

ATC N02AX01

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedValtran 50 mg - 4 mgATCN02AX01REGISTER NO.BE-AMP-SAM118517-00PACKS LISTED4CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about naloxone hydrochloride dihydrateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Naloxone Hydrochloride Dihydrate
Manufacturer
Pfizer
Country
Belgium (BE)
ATC code
N02AX01
ATC class
Tilidine
Defined daily dose
0.2 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 4

  • be_apb
    0097170
  • be_apb
    0720680
  • be_apb
    0097188
  • be_apb
    1499185

Regulatory notes

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

Interactions

2 interactions on record for tilidine.

Mechanism, severity and management for each pair, from a commercially licensed source — included with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan
Check tilidine against other medicinesHow interaction checks work

Tilidine · interactions on record

2 records

2 more interactions with mechanism and management, from a commercially licensed source.

Sign in to check
Mechanism and what to do, in the interaction check
Interaction register. Grades as the source publishes them.

Same medicine, other countries

Tilidine in 15 other countries

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

All tilidine products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Forvel, Naloxon Accord
  • Bulgaria · Форвел
  • Cyprus · Codaxol, Forvel
  • Czechia · Forvel, Naloxone Polpharma
  • Germany · Naloxon Accord, Naloxon B. Braun
  • Denmark · Forvel, Naloxon B. Braun
  • Estonia · Forvel, Ventizolve
  • Spain · Fomed, Naloxona B. Braun
  • Finland · Naloxone Accord, Nexodal
  • France · Naloxone Accord, Naloxone Adapt Pharma
  • United Kingdom (Northern Ireland) · Naloxone Accord-Uk, Naloxone B. Braun Melsungen
  • Greece · Forvel, Νaloxon B.Braun
  • Croatia · Forvel
  • Hungary · Nexodal
  • Ireland · Naloxone Hydrochloride Accord, Naloxone Hydrochloride Mercury Pharmaceuticals (Ireland)
  • Iceland · Naloxon B. Braun, Nyxoid
  • Italy · Naloxone Accord, Naloxone Adapt
  • Liechtenstein · Nyxoid
  • Lithuania · Forvel
  • Luxembourg · Naloxon B. Braun
  • Latvia · Forvel
  • Malta · Forvel
  • Netherlands · Naloxon Hci B. Braun, Naloxon Hcl Accord
  • Norway · Naloxon B. Braun, Naloxon Hameln
  • Poland · Naloxonum Hydrochloricum Wzf
  • Portugal · Forvel, Naloxona Accord
  • Romania · Forvel
  • Sweden · Naloxon Actrevo, Naloxon Hameln
  • Slovenia · Nexodal
  • Slovakia · Naloxone Polpharma

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 FAMHP / AFMPS (Belgium). 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/0ea90333-7264-4aee-862b-898b95fc02f1
GET /v1/drugs/0ea90333-7264-4aee-862b-898b95fc02f1?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": "Oral drops, solution",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Valtran 50 mg - 4 mg",
  "name_fr": "Valtran 50 mg - 4 mg",
  "name_nl": "Valtran 50 mg - 4 mg",
  "amp_code": "SAM118517-00",
  "strengths": [
    "6.0830",
    "6.0830",
    "5.5000",
    "5.5000",
    "71.1970",
    "71.1970",
    "69.2000",
    "69.2000",
    "0.1000",
    "99.9800"
  ],
  "pack_count": 3,
  "substances": [
    "Naloxone Hydrochloride Dihydrate",
    "Naloxone Hydrochloride",
    "Tilidine Hydrochloride Hemihydrate",
    "Tilidine Hydrochloride",
    "Disodium Edetate",
    "Ethanol 96%"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Tilidine",
  "authorisation_numbers": [
    "BE118517"
  ]
}
API referenceMCP serverPlans

See everything about tilidine.

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.

Try it freeOpen in the console