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Netherlands· NL-e3bf42eccd56

Kelzyn 2mg/0,02 mg, tablet met verlengde afgifte

A dienogest und ethinylestradiol product containing dienogest + ethinylestradiol, registered in Netherlands by Exeltis Healthcare S.L. The same ATC class is registered in 9 of our 19 countries.

ATC G03AA16

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedKelzyn 2mg/0,02 mg, tablet met verlen…ATCG03AA16REGISTER NO.NL-e3bf42eccd56PACKS LISTED1CHECKEDSeptember 29, 2026

Where it is registered

Dienogest und ethinylestradiol is registered in 9 of 19 countries.

Countries holding a registration under ATC G03AA16 (dienogest und ethinylestradiol), each read from that country’s own register.

  • This record: Netherlands, from CBG-MEB (Netherlands)
  • 6 of them publish a price we can compare per daily dose

Dienogest und ethinylestradiol · ATC G03AA16

9 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
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
DIENOGEST + ETHINYLESTRADIOL
Manufacturer
Exeltis Healthcare S.L
Country
Netherlands (NL)
ATC code
G03AA16
ATC class
Dienogest und Ethinylestradiol
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    131206

Regulatory notes

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

Interactions

1 interaction on record for dienogest und ethinylestradiol.

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

Dienogest und ethinylestradiol · interactions on record

1 record

1 more interaction 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

Dienogest und ethinylestradiol in 9 other countries

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

All dienogest und ethinylestradiol products

Authorised across Europe · EMA

The same active substance is authorised in 22 EEA countries. Names it is sold under:

  • Austria · Dienorette, Dienovel
  • Belgium · Dienobel, Louise
  • Bulgaria · Жанин
  • Czechia · Aidee, Ayreen
  • Germany · Amobena, Aristelle
  • Denmark · Yana
  • Estonia · Ammily, Jeanine
  • Spain · Adieris, Ailyn Diario
  • Finland · Yanulez
  • France · Misolfa
  • United Kingdom (Northern Ireland) · Dienogest/Ethinylestradiol, Serisima
  • Croatia · Donella
  • Hungary · Dienille, Mistral
  • Ireland · Mistra, Raener
  • Italy · Cemisiana, Dienestra
  • Lithuania · Ammily, Jeanine
  • Luxembourg · Dienobel, Louise
  • Latvia · Ammily, Jeanine
  • Norway · Yana
  • Poland · Aidee, Astha
  • Portugal · Denille, Dienogest + Etinilestradiol Leon Farma
  • Slovakia · Aidee, Dienorette

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/baf7e544-c1a9-40b1-aeb1-b774cccc685d
GET /v1/drugs/baf7e544-c1a9-40b1-aeb1-b774cccc685d?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": "Tablet met verlengde afgifte",
  "route": "Oraal gebruik",
  "soort": "RVG",
  "source": "cbg_meb",
  "smpc_url": "https://www.geneesmiddeleninformatiebank.nl/smpc/h131206_smpc_en.pdf",
  "strength": null,
  "atc_label": "Dienogest and ethinylestradiol",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/rvg131206",
  "excipients": [
    "GLYCEROLTRIACETAAT (E 1518)",
    "HYPROMELLOSE 2208, K100 (E 464)",
    "HYPROMELLOSE 2910 (3 - 15 mPa.s) (E 464)",
    "IJZEROXIDE GEEL (E 172)",
    "INDIGOKARMIJN ALUMINIUMLAK (E 132)",
    "LACTOSE 1-WATER",
    "LACTOSE 1-WATER",
    "MACROGOL",
    "MACROGOL 3350",
    "MAGNESIUMSTEARAAT (E 470b)",
    "MAGNESIUMSTEARAAT (E 470b)",
    "MAÏSZETMEEL",
    "POLYSORBAAT 80 (E 433)",
    "POLYVINYLALCOHOL (E 1203)",
    "POVIDON K 30 (E 1201)",
    "POVIDON K 30 (E 1201)",
    "SILICIUMDIOXIDE (E 551)",
    "SILICIUMDIOXIDE (E 551)",
    "TALK (E 553b)",
    "TITAANDIOXIDE (E 171)",
    "TITAANDIOXIDE (E 171)"
  ],
  "substances": [
    "DIENOGEST",
    "ETHINYLESTRADIOL"
  ],
  "leaflet_url": "https://www.geneesmiddeleninformatiebank.nl/bijsluiters/h131206_piluk.pdf",
  "authorised_at": "2024/03/20",
  "procedure_number": "SE/H/2378/001",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "131206",
  "additional_monitoring": "N"
}

See everything about dienogest und ethinylestradiol.

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.