Back to search

Belgium· BE-AMP-SAM585404-00

Drovelis 3 mg - 14.2 mg

A drospirenone and estetrol product containing placebo, registered in Belgium by Gedeon Richter. The same ATC class is registered in 12 of our 19 countries.

ATC G03AA18

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedDrovelis 3 mg - 14.2 mgATCG03AA18REGISTER NO.BE-AMP-SAM585404-00PACKS LISTED4CHECKEDSeptember 26, 2026

Where it is registered

Drospirenone and estetrol is registered in 12 of 19 countries.

Countries holding a registration under ATC G03AA18 (drospirenone and estetrol), 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

Drospirenone and estetrol · ATC G03AA18

12 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
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
Placebo
Manufacturer
Gedeon Richter
Country
Belgium (BE)
ATC code
G03AA18
ATC class
Drospirenone and estetrol
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 4

  • be_apb
    4375424
  • be_apb
    7731342
  • be_apb
    4375416
  • be_apb
    4375432

Regulatory notes

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

Same medicine, other countries

Drospirenone and estetrol in 2 other countries

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

All drospirenone and estetrol products

Authorised across Europe · EMA

The same active substance is authorised in 1 EEA country. Names it is sold under:

  • Germany · P-Tabletten Weiß 7 Mm Lichtenstein

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/14e07101-090f-4328-ac83-744336930122
GET /v1/drugs/14e07101-090f-4328-ac83-744336930122?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": "Drovelis 3 mg - 14.2 mg",
  "name_fr": "Drovelis 3 mg - 14.2 mg",
  "name_nl": "Drovelis 3 mg - 14.2 mg",
  "amp_code": "SAM585404-00",
  "strengths": [
    "68.0000",
    "14.2000",
    "3.0000",
    "40.0000"
  ],
  "pack_count": 4,
  "substances": [
    "Placebo",
    "Lactose Monohydrate",
    "Estetrol Monohydrate",
    "Estetrol",
    "Drospirenone",
    "Sodium Starch Glycolate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Drospirenone and Estetrol",
  "authorisation_numbers": [
    "EU/1/21/1547/001",
    "EU/1/21/1547/002",
    "EU/1/21/1547/004",
    "EU/1/21/1547/003"
  ]
}

See everything about drospirenone and estetrol.

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.