Germany· DE-A57-417a056c546dee8c
Balanca
A medicinal product containing chlormadinone acetate, 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
- Chlormadinone Acetate, Ethinylestradiol
- Manufacturer
- Gedeon Richter Plc.
- Country
- Germany (DE)
- ATC code
- —
- 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
Chlormadinone acetate, ethinylestradiol in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandBelara, FilmtablettenGedeon Richter (Schweiz) AG
- CzechiaBELARAGedeon Richter Plc., Budapešť
- SpainBALIANCA 2 mg/0,03 mg COMPRIMIDOS RECUBIERTOS CON PELICULAGedeon Richter Plc.
- PolandBelaraDelfarma Sp. z o.o.
- FranceBELARA 0,03 mg/2 mg, comprimé pelliculéGEDEON RICHTER ( HONGRIE)
Authorised across Europe · EMA
The same active substance is authorised in 18 EEA countries. Names it is sold under:
- Austria · Balanca, Belara
- Belgium · Bellina, Helen
- Czechia · Belara, Clormetin
- Estonia · Clormetin
- Spain · Belara, Clormadinona/Etinilestradiol Stadafarma
- France · Belara
- Greece · Labous
- Croatia · Belara, Estal
- Hungary · Belara
- Italy · Belara, Eve
- Lithuania · Belara
- Luxembourg · Bellina, Bellissima
- Latvia · Belara, Clormetin
- Poland · Belara, Madinette
- Portugal · Belara, Chariva
- Romania · Belara
- Slovenia · Belara
- Slovakia · Belara, Lydely
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/eb5ad982-5e51-4e72-9135-f2f1f6e4b434 GET /v1/drugs/eb5ad982-5e51-4e72-9135-f2f1f6e4b434?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": "Chlormadinone Acetate, Ethinylestradiol",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about chlormadinone acetate, 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.