Iceland· IS-EU/1/15/1076/004 & 014 &019-020
Kovaltry
A coagulation factor viii product containing octocog alfa, registered in Iceland by Bayer AG*. The same ATC class is registered in 11 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) 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: Iceland, from Icelandic Medicines Agency (Iceland)
- 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
Icelandic Medicines Agency (Iceland)- Active substance
- Octocog alfa
- Manufacturer
- Bayer AG*
- Country
- Iceland (IS)
- ATC code
- B02BD02
- ATC class
- Coagulation factor VIII
- Defined daily dose
- 1 TSD, E
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 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.
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.
- BelgiumAdvate 1000 IUTakeda Manufacturing Austria
- CzechiaADVATETakeda Manufacturing Austria AG, Vídeň
- SpainADVATE 1.000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLETakeda Manufacturing Austria Ag
- FinlandAdvateAbacus Medicine A/S
- United KingdomAdvate 1,000unit powder and solvent for solution for injection vialsTakeda UK Ltd
- IrelandAdvate 1000 IU/2 ml powder and solvent for solution for injectionTakeda Manufacturing Austria AG
- NetherlandsAdvate 1000 IU, poeder en oplosmiddel voor oplossing voor injectie 200 IU/mlTakeda Manufacturing Austria AG
- ItalyADVATE*1 flaconcino EV 1.000 Unita' Internazionali + 1 flaconcino solv 2 ml preassemblati con dispositivo per ricostituzioneTAKEDA MANUFACTURING AUS. AG
Authorised across Europe · EMA
The same active substance is authorised in 6 EEA countries. Names it is sold under:
- Germany · Recombinate
- Italy · Recombinate
- Liechtenstein · Advate, Kovaltry
- Lithuania · Recombinate
- Netherlands · Recombinate
- Norway · Advate, Kovaltry
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 Icelandic Medicines Agency (Iceland). 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/e1fa75e0-7162-4adf-8bb3-43fa0e6ce1a6 GET /v1/drugs/e1fa75e0-7162-4adf-8bb3-43fa0e6ce1a6?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": "Stungulyfsstofn og leysir, lausn í áfylltri sprautu",
"source": "lyfjastofnun",
"atc_raw": "B02BD02",
"marketed": false,
"strength": "500 a.e.",
"ma_number": "EU/1/15/1076/004 & 014 &019-020",
"substance": "Octocog alfa",
"other_info": "Ávísun lyfsins er bundin við sérfræðinga í blóðsjúkdómum.",
"legal_status": "(R Z) Sérfræðingsmerkt (og lyfseðilsskylt)",
"ma_issued_serial": "42418"
}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.