Belgium· BE-AMP-SAM304683-00
Actonel Combi D 35 mg - 1000 mg - 880 IU
A risedronsäure, calcium und colecalciferol, sequenzialpräparate product containing sodium risedronate, registered in Belgium by Theramex Ireland. The same ATC class is registered in 3 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
Where it is registered
Risedronsäure, calcium und colecalciferol, sequenzialpräparate is registered in 3 of 19 countries.
Countries holding a registration under ATC M05BB04 (risedronsäure, calcium und colecalciferol, sequenzialpräparate), each read from that country’s own register.
- This record: Belgium, from FAMHP / AFMPS (Belgium)
- 2 of them publish a price we can compare per daily dose
Risedronsäure, calcium und colecalciferol, sequenzialpräparate · ATC M05BB04
3 / 19 countries
- Belgiumprice
- Finlandprice
- Netherlands
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Sodium Risedronate
- Manufacturer
- Theramex Ireland
- Country
- Belgium (BE)
- ATC code
- M05BB04
- ATC class
- Risedronsäure, Calcium und Colecalciferol, Sequenzialpräparate
- Defined daily dose
- 5 mg, O
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 2
1 priced- be_apb2613024EUR 29.48
- be_apb0792929
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Risedronsäure, calcium und colecalciferol, sequenzialpräparate in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainACREL SEMANAL 35 mg COMPRIMIDOS RECUBIERTOS CON PELICULATheramex Ireland Limited
- ItalyACTONELTHERAMEX IRELAND LIMITED
- FranceACTONEL 35 mg, comprimé pelliculéTHERAMEX IRELAND (IRLANDE)
- NetherlandsNatriumrisedronaat Sandoz Wekelijks 35 mg, filmomhulde tablettenSandoz B.V.
- FinlandRisedronat PfizerPfizer Oy
- SwedenRisedronat Ebb 35 mg Filmdragerad tablettEbb Medical AB
- PolandRisendros 35Zentiva, k.s.
- IcelandRisedronate BluefishBluefish Pharmaceuticals AB
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Germany · Risedronat Al
- France · Risedronate Eg
- Italy · Risedronato Eg Stada
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/68c514a8-39a5-498d-8ec2-bc79a042bc59 GET /v1/drugs/68c514a8-39a5-498d-8ec2-bc79a042bc59?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": "Actonel Combi D 35 mg - 1000 mg - 880 IU",
"name_fr": "Actonel Combi D 35 mg - 1000 mg - 880 IU",
"name_nl": "Actonel Combi D 35 mg - 1000 mg - 880 IU",
"amp_code": "SAM304683-00",
"strengths": [
"35.0000",
"32.5000",
"126.0000",
"880.0000",
"2500.0000",
"1000.0000",
"660.0000",
"8.0000",
"80.0000",
"3344.0000",
"288.4000"
],
"pack_count": 7,
"substances": [
"Sodium Risedronate",
"Risedronic Acid",
"Lactose Monohydrate",
"Cholecalciferol",
"Calcium Carbonate",
"Calcium",
"Glycine max - Glycine soja (Ph.Eur. mixture), Bean, Oil - Hydrogenated",
"Saccharin Sodium",
"Sodium Cyclamate",
"Sucrose",
"Potassium Carbonate"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Risedronic Acid, Calcium and Colecalciferol, Sequential",
"authorisation_numbers": [
"BE304683"
]
}See everything about risedronsäure, calcium und colecalciferol, sequenzialpräparate.
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.