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Belgium· BE-AMP-SAM512186-00

Emtricitabine/Tenofovir Disoproxil Krka 200 mg - 245 mg

A tenofovir disoproxil and emtricitabine product containing emtricitabine, registered in Belgium by KRKA d.d. Novo mesto. The same ATC class is registered in 13 of our 19 countries.

ATC J05AR03

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedEmtricitabine/Tenofovir Disoproxil Kr…ATCJ05AR03REGISTER NO.BE-AMP-SAM512186-00PACKS LISTED12CHECKEDSeptember 26, 2026

Where it is registered

Tenofovir disoproxil and emtricitabine is registered in 13 of 19 countries.

Countries holding a registration under ATC J05AR03 (tenofovir disoproxil and emtricitabine), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 8 of them publish a price we can compare per daily dose

Tenofovir disoproxil and emtricitabine · ATC J05AR03

13 / 19 countries

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

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Emtricitabine
Manufacturer
KRKA d.d. Novo mesto
Country
Belgium (BE)
ATC code
J05AR03
ATC class
Tenofovir disoproxil and emtricitabine
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 12

5 priced
  • be_apb
    4816138
    EUR 365.41
  • be_apb
    5826888
    EUR 365.41
  • be_apb
    5812375
    EUR 365.41
  • be_apb
    7720212
  • be_apb
    4204459
  • be_apb
    7727969
  • be_apb
    4204467
  • be_apb
    7740764
  • be_apb
    7748874
  • be_apb
    7748882
  • be_apb
    3546702
    EUR 365.41
  • be_apb
    3546710
    EUR 158.65

Regulatory notes

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

Interactions

9 interactions on record for tenofovir disoproxil and emtricitabine.

Mechanism, severity and management for each pair, from a commercially licensed source — included 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

Tenofovir disoproxil and emtricitabine · interactions on record

9 records

9 more interactions with mechanism and management, from a commercially licensed source.

Sign in to check
Mechanism and what to do, in the interaction check
Interaction register. Grades as the source publishes them.

Same medicine, other countries

Tenofovir disoproxil and emtricitabine in 13 other countries

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

All tenofovir disoproxil and emtricitabine products

Authorised across Europe · EMA

The same active substance is authorised in 4 EEA countries. Names it is sold under:

  • Spain · Emtricitabina/Tenofovir Alafenamida Dr. Reddys
  • Iceland · Emtriva
  • Liechtenstein · Emtriva
  • Norway · Emtriva

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/b913fd1e-b470-45a4-b250-f5b25e9ef63f
GET /v1/drugs/b913fd1e-b470-45a4-b250-f5b25e9ef63f?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": "Emtricitabine/Tenofovir Disoproxil Krka 200 mg - 245 mg",
  "name_fr": "Emtricitabine/Tenofovir Disoproxil Krka 200 mg - 245 mg",
  "name_nl": "Emtricitabine/Tenofovir Disoproxil Krka 200 mg - 245 mg",
  "amp_code": "SAM512186-00",
  "strengths": [
    "200.0000",
    "200.0000",
    "300.7000",
    "300.7000",
    "245.0000",
    "245.0000",
    "80.0000"
  ],
  "pack_count": 10,
  "substances": [
    "Emtricitabine",
    "Tenofovir Disoproxil Succinate",
    "Tenofovir Disoproxil",
    "Lactose Monohydrate",
    "Sodium Stearyl Fumarate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Tenofovir Disoproxil and Emtricitabine",
  "authorisation_numbers": [
    "EU/1/16/1151/001",
    "EU/1/16/1151/003",
    "EU/1/16/1151/002",
    "EU/1/16/1151/004",
    "EU/1/16/1151/005"
  ]
}

See everything about tenofovir disoproxil and emtricitabine.

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.