Belgium· BE-AMP-SAM485866-00
Elocta 3000 IU
A coagulation factor viii product containing efmoroctocog alfa, registered in Belgium by Swedish Orphan Biovitrum (Publ). The same ATC class is registered in 11 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
Where it is registered
Coagulation factor viii is registered in 11 of 19 countries.
Countries holding a registration under ATC B02BD02 (coagulation factor viii), each read from that country’s own register.
- This record: Belgium, from FAMHP / AFMPS (Belgium)
- 7 of them publish a price we can compare per daily dose
Coagulation factor viii · ATC B02BD02
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Efmoroctocog Alfa
- Manufacturer
- Swedish Orphan Biovitrum (Publ)
- Country
- Belgium (BE)
- ATC code
- B02BD02
- ATC class
- Coagulation factor VIII
- Defined daily dose
- 1 TSD, E
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 6
3 priced- be_apb7716970
- be_apb7737380
- be_apb7738321
- be_apb3393980EUR 2282.52
- be_apb4672440EUR 2282.52
- be_apb4607800EUR 2282.52
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
4 interactions on record for coagulation factor viii.
Graded by severity as the source publishes them — 2 severe. Severity grades are free for everyone; mechanism and management come 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
Coagulation factor viii · interactions on record
4 records
- 2 severe
- 2 moderate
Most severe, free to view
- CarfilzomibL01XG02severe
- CarfilzomibL01XX45severe
- PegvaliaseA16AB19moderate
- EmicizumabB02BX06moderate
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Coagulation factor viii in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainElocta 3000 UI polvo y disolvente para solucion inyectableSwedish Orphan Biovitrum Ab (Publ)
- NorwayEloctaSwedish Orphan Biovitrum International AB
- PolandEloctaSwedish Orphan Biovitrum AB (publ)
- SwedenELOCTA 3000 IE Pulver och vätska till injektionsvätska, lösningSwedish Orphan Biovitrum AB (publ)
- FinlandEloctaSwedish Orphan Biovitrum AB (publ)
- NetherlandsElocta 1000 IU, poeder en oplosmiddel voor oplossing voor injectieSwedish Orphan Biovitrum AB (publ)
- FranceELOCTA 1000 UI, poudre et solvant pour solution injectableSWEDISH ORPHAN BIOVITRUM INTERNATIONAL (SUEDE)
- United KingdomElocta 1,000unit powder and solvent for solution for injection vialsSwedish Orphan Biovitrum Ltd
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Elocta
- Liechtenstein · Elocta
- Norway · Elocta
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/56a47ba8-3cf3-4b38-8186-a073bdbbfe5e GET /v1/drugs/56a47ba8-3cf3-4b38-8186-a073bdbbfe5e?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": "Powder and solvent for solution for injection",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Elocta 3000 IU",
"name_fr": "Elocta 3000 IU",
"name_nl": "Elocta 3000 IU",
"amp_code": "SAM485866-00",
"strengths": [
"3000.0000",
"14.0000"
],
"pack_count": 3,
"substances": [
"Efmoroctocog Alfa",
"Sucrose",
"Polysorbate 20",
"Sodium"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Coagulation Factor VIII",
"authorisation_numbers": [
"EU/1/15/1046/007"
]
}See everything about coagulation factor viii.
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.