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Netherlands· NL-0e9580fac02e

Harvoni 45 mg/200 mg, granulaat

A sofosbuvir and ledipasvir product containing ledipasvir acetonsolvaat + sofosbuvir, registered in Netherlands by Gilead Sciences Ireland UC. The same ATC class is registered in 13 of our 19 countries.

ATC J05AP51

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedHarvoni 45 mg/200 mg, granulaatATCJ05AP51REGISTER NO.NL-0e9580fac02ePACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about ledipasvir acetonsolvaat + sofosbuvirAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Sofosbuvir and ledipasvir is registered in 13 of 19 countries.

Countries holding a registration under ATC J05AP51 (sofosbuvir and ledipasvir), each read from that country’s own register.

  • This record: Netherlands, from CBG-MEB (Netherlands)
  • 8 of them publish a price we can compare per daily dose
Search sofosbuvir and ledipasvir products by name

Sofosbuvir and ledipasvir · ATC J05AP51

13 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • 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.

The record

At a glance

CBG-MEB (Netherlands)
Active substance
LEDIPASVIR ACETONSOLVAAT + SOFOSBUVIR
Manufacturer
Gilead Sciences Ireland UC
Country
Netherlands (NL)
ATC code
J05AP51
ATC class
Sofosbuvir and ledipasvir
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/14/958

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Sofosbuvir and ledipasvir in 12 other countries

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

All sofosbuvir and ledipasvir products

Authorised across Europe · EMA

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

  • Iceland · Harvoni
  • Liechtenstein · Harvoni
  • Norway · Harvoni

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 CBG-MEB (Netherlands). 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/d06b8cfb-a0ed-4c14-8006-ae699f460a13
GET /v1/drugs/d06b8cfb-a0ed-4c14-8006-ae699f460a13?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": "Filmomhulde tablet",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/harvoni-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Sofosbuvir and ledipasvir",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp125181",
  "excipients": [
    "BASISCH GEBUTYLEERD METHACRYLAAT COPOLYMEER (E 1205)",
    "CELLULOSE, MICROKRISTALLIJN (E 460(i))",
    "COPOVIDON (E 1208)",
    "CROSCARMELLOSE  NATRIUM  (E 468)",
    "HYPROMELLOSE 2910 (3 - 15 mPa.s) (E 464)",
    "IJZEROXIDE GEEL (E 172)",
    "IJZEROXIDE ROOD  (E 172)",
    "LACTOSE 1-WATER",
    "MACROGOL 3350",
    "MAGNESIUMSTEARAAT (E 470b)",
    "POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203)",
    "SILICIUMDIOXIDE (E 551)",
    "TALK (E 553b)",
    "TITAANDIOXIDE (E 171)"
  ],
  "substances": [
    "LEDIPASVIR ACETONSOLVAAT",
    "SOFOSBUVIR"
  ],
  "leaflet_url": null,
  "authorised_at": "2014/11/17",
  "procedure_number": "EMEA/H/C/003850",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/14/958",
  "additional_monitoring": "N"
}
API referenceMCP serverPlans

See everything about sofosbuvir and ledipasvir.

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.

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