Belgium· BE-AMP-SAM548044-00
Simvastatine Mylan 80 mg
A medicinal product containing simvastatin, registered in Belgium by Viatris GX.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Simvastatin
- Manufacturer
- Viatris GX
- Country
- Belgium (BE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Simvastatin in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatessimvastatinAccord Healthcare, Inc.
- FinlandLipcutOrifarm Oy
- SwitzerlandSimcora 80, FilmtablettenSandoz Pharmaceuticals AG
- NetherlandsSimvastatine 80 mg Teva, filmomhulde tablettenTeva Nederland B.V.
- SwedenSimvastatin Bluefish 80 mg Filmdragerad tablettBluefish Pharmaceuticals AB
- IcelandSimvastatin BluefishBluefish Pharmaceuticals AB
- NorwaySimvastatin BluefishBluefish Pharmaceuticals AB
- PolandSimorionOrion Corporation
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Gerosim, Simvastad
- Bulgaria · Simvacor 10 Mg, Simvacor 20 Mg
- Cyprus · Kymazol, Priacin
- Czechia · Simvastatin Ratiopharm, Simvastatin Viatris
- Germany · Simva, Simva Tad
- Denmark · Perichol, Simvastatin Hexal
- Estonia · Simvacor, Simvastatin Ratiopharm
- Spain · Alcosin, Pantok
- Finland · Lipcut, Simvastatin Krka
- France · Simvastatine Accord Healthcare, Simvastatine Almus
- United Kingdom (Northern Ireland) · Ranzolont, Simvastatin
- Greece · Antichol, Bevostatin
- Croatia · Lipex, Lipterra
- Hungary · Sicor, Simvacol
- Ireland · Simtan, Simvastatin Bluefish
- Iceland · Simvastatin Actavis, Simvastatin Bluefish
- Italy · Alpheus, Krustat
- Lithuania · Simvacor
- Luxembourg · Simvastatin Ratiopharm, Simvastatin Sandoz
- Latvia · Simvacor
- Malta · Priacin, Simtan
- Netherlands · Simvastatin Aurobindo, Simvastatin Teva
- Norway · Simvastatin Bluefish, Simvastatin Hexal
- Poland · Apo-Simva, Simcovas
- Portugal · Simvastatin Ratiopharm, Simvastatina Ratiopharm
- Romania · Simvacard, Simvastatin Terapia
- Sweden · Simvastatin Bluefish, Simvastatin Brown
- Slovenia · Simvastatin Lek, Sinvacor
- Slovakia · Simvacard, Simvastatin Ratiopharm
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/df994a07-787a-4018-8be0-2876c1a660f3 GET /v1/drugs/df994a07-787a-4018-8be0-2876c1a660f3?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": "Film-coated tablet",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Simvastatine Mylan 80 mg",
"name_fr": "Simvastatine Mylan 80 mg",
"name_nl": "Simvastatine Mylan 80 mg",
"amp_code": "SAM548044-00",
"strengths": [
"80.0000"
],
"pack_count": 0,
"substances": [
"Simvastatin"
],
"medicine_type": "ALLOPATHIC",
"atc_description": null,
"authorisation_numbers": null
}See everything about simvastatin.
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.