Belgium· BE-AMP-SAM211102-00
Valtran Retard 100 mg - 8 mg
A tilidine product containing naloxone hydrochloride dihydrate, registered in Belgium by Pfizer.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
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 · 3
- be_apb1682277
- be_apb0769885
- be_apb2086924
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
Tilidine · interactions on record
2 records
2 more interactions with mechanism and management, from a commercially licensed source.
Sign in to checkSame 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.
- United StatesKLOXXADOHikma Specialty USA Inc.
- United KingdomNaloxone 1.26mg/0.1ml nasal spray unit doseAccord-UK Ltd
- GermanyNaloxon AccordAccord Healthcare B.V.
- CanadaINJECTABLE NALOXONE HYDROCHLORIDEOMEGA LABORATORIES LIMITED
- PolandNaloxone AccordAccord Healthcare Polska Sp. z o.o.
- FinlandNalofarmOrifarm Oy
- SwedenNaloxon actrevo 3,6 mg Nässpray, lösning i endosbehållareActrevo GmbH
- NetherlandsNaloxon HCl Accord 0,4 mg/ml, oplossing voor injectie / infusie in een voorgevulde spuitAccord Healthcare B.V.
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/4c2c467d-762c-47a0-86f4-b435ae6d6ffb GET /v1/drugs/4c2c467d-762c-47a0-86f4-b435ae6d6ffb?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": "Prolonged-release tablet",
"source": "afmps",
"status": "REVOKED",
"name_en": "Valtran Retard 100 mg - 8 mg",
"name_fr": "Valtran Retard 100 mg - 8 mg",
"name_nl": "Valtran Retard 100 mg - 8 mg",
"amp_code": "SAM211102-00",
"strengths": [
"8.8000",
"8.8000",
"8.0000",
"8.0000",
"119.8600",
"119.8600",
"100.0000",
"100.0000",
"79.8400"
],
"pack_count": 3,
"substances": [
"Naloxone Hydrochloride Dihydrate",
"Naloxone Hydrochloride",
"Tilidine Phosphate",
"Tilidine Hydrochloride",
"Lactose"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Tilidine",
"authorisation_numbers": [
"BE211102"
]
}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.