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Belgium· BE-AMP-SAM666542-00

Orladeyo 132 mg

A berotralstat product containing berotralstat dihydrochloride, registered in Belgium by Biocryst Ireland. The same ATC class is registered in 17 of our 19 countries.

ATC B06AC06

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedOrladeyo 132 mgATCB06AC06REGISTER NO.BE-AMP-SAM666542-00PACKS LISTED0CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about berotralstat dihydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Berotralstat is registered in 17 of 19 countries.

Countries holding a registration under ATC B06AC06 (berotralstat), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 11 of them publish a price we can compare per daily dose
Search berotralstat products by name

Berotralstat · ATC B06AC06

17 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of berotralstat costs, country by country.

Normalised to the WHO defined daily dose (0.15 g), so markets compare like for like.

  • 1 market with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown
Open the full comparison — free accountDrug prices for market access

Berotralstat · price per daily dose (0.15 g)

USD · FX 28 Sept 2026

  • CH Switzerland$576.89
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Berotralstat Dihydrochloride
Manufacturer
Biocryst Ireland
Country
Belgium (BE)
ATC code
B06AC06
ATC class
Berotralstat
Defined daily dose
0.15 g, O
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.

Interactions

209 interactions on record for berotralstat.

Graded by severity as the source publishes them — 66 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
Check berotralstat against other medicinesHow interaction checks work

Berotralstat · interactions on record

209 records

  • 66 severe
  • 132 moderate
  • 11 minor

Most severe, free to view

  • RolapitantA04AD14severe
  • NaloxegolA06AH03severe
  • FidaxomicinA07AA12severe
  • EliglustatA16AX10severe
  • 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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Berotralstat in 15 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All berotralstat products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Orladeyo
  • Liechtenstein · Orladeyo
  • Norway · Orladeyo

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/2c6978fd-471e-44bd-a1d5-4a09ac367e87
GET /v1/drugs/2c6978fd-471e-44bd-a1d5-4a09ac367e87?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 granules in sachet",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Orladeyo 132 mg",
  "name_fr": "Orladeyo 132 mg",
  "name_nl": "Orladeyo 132 mg",
  "amp_code": "SAM666542-00",
  "strengths": [
    "132.0000",
    "132.0000"
  ],
  "pack_count": 1,
  "substances": [
    "Berotralstat Dihydrochloride",
    "Berotralstat",
    "Sodium Laurilsulfate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Berotralstat",
  "authorisation_numbers": [
    "EU/1/21/1544/006"
  ]
}
API referenceMCP serverPlans

See everything about berotralstat.

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.

Try it freeOpen in the console