Germany· DE-A57-cf16dc0afb1c9db9
Monostep
A ethinylestradiol, levonorgestrel product containing ethinylestradiol, levonorgestrel, registered in Germany by Bayer Vital Gmbh.
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
- Ethinylestradiol, Levonorgestrel
- Manufacturer
- Bayer Vital Gmbh
- Country
- Germany (DE)
- ATC code
- Ethinylestradiol, LEVONORGESTREL
- ATC class
- Ethinylestradiol, LEVONORGESTREL
- 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
Ethinylestradiol, levonorgestrel in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandEffilevo 0.10 mg / 0.02 mg, comprimés pelliculésEFFIK SA
- SpainAILEVA 0,1 MG/0,02 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFGLaboratorios Cinfa S.A.
- CzechiaASUMATEExeltis Czech s.r.o., Praha
- United KingdomAmbelina 150microgram/30microgram tabletsCrescent Pharma Ltd
- FranceADEPAL, comprimé enrobéPFIZER HOLDING FRANCE
- NetherlandsEthinylestradiol/Levonorgestrel 0,02 mg/0,10 mg Focus, filmomhulde tablettenFocus Care Pharmaceuticals B.V.
- CanadaALESSE 21PFIZER CANADA ULC
- FinlandAnyaWyeth Lederle Nordiska Ab
Authorised across Europe · EMA
The same active substance is authorised in 24 EEA countries. Names it is sold under:
- Austria · Erlidona, Ethinylestradiol/Levonorgestrel Nextpharma
- Belgium · Eleonor 20, Lavinia
- Bulgaria · Три-Регол
- Czechia · Ebelya, Minisiston
- Denmark · Anastrella, Femicept
- Spain · Aileva, Anaomi
- France · Adepal, Asterluna
- United Kingdom (Northern Ireland) · Ambelina, Elevin
- Croatia · Adexa
- Hungary · Rigevidon, Seasonique
- Ireland · Leonore, Levonorgestrel/ Ethinylestradiol Renata Pharmaceuticals (Ireland)
- Iceland · Levoethin, Melleva
- Italy · Egogyn, Lasca
- Lithuania · Rigevidon, Tri - Regol
- Luxembourg · Levorichter 30, Lowette
- Latvia · Rigevidon
- Netherlands · Ethinylestradiol/Levonorgestrel Ceres Pharma, Ethinylestradiol/Levonorgestrel Focus
- Norway · Melleva, Microgynon
- Poland · Levomine, Levomine Mini
- Portugal · Effilevo, Etinilestradiol + Levonorgestrel Generis
- Romania · Microgynon, Seasonique
- Sweden · Anastrella, Leverette 21
- Slovenia · Stediril-M
- Slovakia · Ebelya, Seasonique
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/ed099a64-5966-4fbd-b667-4b105adf159a GET /v1/drugs/ed099a64-5966-4fbd-b667-4b105adf159a?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": "Ethinylestradiol, Levonorgestrel",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about ethinylestradiol, levonorgestrel.
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.