Germany· DE-A57-f6b56154e3c702c1
Sibilla
A dienogest, ethinylestradiol product containing dienogest, ethinylestradiol, registered in Germany by Gedeon Richter Plc..
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Dienogest, Ethinylestradiol
- Manufacturer
- Gedeon Richter Plc.
- Country
- Germany (DE)
- ATC code
- DIENOGEST, Ethinylestradiol
- ATC class
- DIENOGEST, Ethinylestradiol
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 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.
Same medicine, other countries
Dienogest, ethinylestradiol in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaAIDEEVIVAX Pharmaceuticals, s.r.o., Povážská Bystrica
- PolandAideeInPharm Sp. z o.o.
- SpainADIERIS 2 mg/0,03 mg COMPRIMIDO RECUBIERTO CON PELICULA EFGLaboratorios Cinfa S.A.
- SwitzerlandCemisiana 2 mg / 0.03 mg, FilmtablettenSandoz Pharmaceuticals AG
- FinlandCelimonaBayer Schering Pharma Oy
- FranceJEZTIQ 2 mg/0,02 mg, comprimé à libération prolongéeEXELTIS SANTE
- IrelandKelzy 2 mg/0.02 mg prolonged release tabletsExeltis Healthcare S.L.
- NetherlandsKelzyn 2mg/0,02 mg, tablet met verlengde afgifteExeltis Healthcare S.L
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
- 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
- Netherlands · Ethinylestradiol/Dienogest Mithra, Misolfa
- 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 EMA Article 57 (European Union). 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/e1a73f46-8aed-4878-a664-e298bc9690f8 GET /v1/drugs/e1a73f46-8aed-4878-a664-e298bc9690f8?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.
{
"pzn": null,
"route": "Oral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Dienogest, Ethinylestradiol",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about dienogest, 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.