Germany· DE-A57-3d7ab57fad526e8a
Betoptima
A medicinal product containing betaxolol hydrochloride, registered in Germany by Immedica Pharma Ab.
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
- Betaxolol Hydrochloride
- Manufacturer
- Immedica Pharma Ab
- 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
Betaxolol hydrochloride in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaBETAMEDMedochemie Ltd., Limassol
- United KingdomBetaxolol 0.25% eye dropsSigma Pharmaceuticals Plc
- PolandBetaxolol MedregMedreg s.r.o.
- United StatesBetaxololEpic Pharma LLC
- FranceBETAXOLOL BIOGARAN 20 mg, comprimé pelliculé sécableBIOGARAN
- FinlandBetopticImmedica Pharma AB
- BelgiumBetoptic 5 mg/mlNovartis Pharma
- NorwayBetopticImmedica Pharma AB
Authorised across Europe · EMA
The same active substance is authorised in 26 EEA countries. Names it is sold under:
- Austria · Betoptic S
- Belgium · Betoptic, Betoptic S
- Bulgaria · Бетак, Бетоптик S
- Cyprus · Betac
- Czechia · Betamed, Betaxolol Medreg
- Denmark · Betoptic S
- Estonia · Betoptic S
- Spain · Betoptic
- Finland · Betoptic, Betoptic S
- France · Betaxolol Biogaran, Betaxolol Eg
- United Kingdom (Northern Ireland) · Betoptic
- Greece · Betoptic, Betoptic S
- Croatia · Betoptic
- Hungary · Betoptic, Lokren
- Italy · Betoptic, Kerlon
- Lithuania · Betac, Betaxolol Pmcs
- Luxembourg · Betoptic, Betoptic S
- Latvia · Betac, Betaxolol Pmcs
- Netherlands · Betoptic S
- Norway · Betoptic, Betoptic S
- Poland · Betaxolol Medreg, Betaxolol Pmcs
- Portugal · Bertocil, Betoptic
- Romania · Betaxolol Gemax Pharma, Betoptic S
- Sweden · Betoptic, Betoptic S
- Slovenia · Betoptic, Betoptic S
- Slovakia · Betac, Betaxolol Medreg
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/348c6382-9e9d-41a4-b212-b1f26b87a638 GET /v1/drugs/348c6382-9e9d-41a4-b212-b1f26b87a638?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": "Ocular Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Betaxolol Hydrochloride",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about betaxolol hydrochloride.
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.