Germany· DE-A57-7d57090dc9ac84d3
Cosopt-S
A medicinal product containing dorzolamide hydrochloride, timolol maleate, registered in Germany by Santen Oy.
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
- Dorzolamide Hydrochloride, Timolol Maleate
- Manufacturer
- Santen Oy
- 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
Dorzolamide hydrochloride, timolol maleate in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomCodimaz 20mg/ml / 5mg/ml eye dropsScope Ophthalmics Ltd
- CzechiaAMIPTICZaklady Farmaceutyczne Polpharma SA, Starogard Gdański
- SwedenCosopt 20 mg/ml + 5 mg/ml Ögondroppar, lösningSanten Oy
- United StatesCOSOPTThea Pharma Inc.
- SpainARZOTIM 20 MG/ML + 5 MG/ML COLIRIO EN SOLUCIONTiedra Farmaceutica S.L.
- FinlandCosoptSanten Oy
- PolandCosoptSanten Oy
- ItalyBETACLAROMNIVISION ITALIA S.R.L.
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Cosopt, Cosopt Sine
- Belgium · Cosopt, Cosopt Sine Conservans
- Bulgaria · Амиптифри, Дорзасопт
- Cyprus · Cosopt, Cosopt Imulti
- Czechia · Amiptic, Cosopt
- Denmark · Cosopt, Cosopt Imulti Ukonserveret
- Estonia · Cosopt, Dorzolamide/Timolol Elvim
- Spain · Arzotim, Cosduo
- Finland · Cosopt, Cosopt Sine
- France · Atimiac, Cosidime
- United Kingdom (Northern Ireland) · Codimaz, Cosopt
- Greece · Apleona, Cosopt
- Croatia · Apleona, Cosopt
- Hungary · Cosopt, Cosopt Multi
- Ireland · Cosopt, Cosopt Preservative-Free
- Iceland · Arzotilol, Cosopt Sine
- Italy · Betaclar, Cosopt
- Lithuania · Cosopt, Cosopt Sine
- Luxembourg · Cosopt, Cosopt Sine Conservans
- Latvia · Amiptic, Amiptinon
- Malta · Cosopt Preservative-Free
- Netherlands · Cosopt, Cosopt Conserveermiddelvrij, Oogdruppels, Oplossing, Flacon Voor Eenmalig Gebruik
- Norway · Apleona, Cosopt
- Poland · Cosopt, Cosopt Pf
- Portugal · Cosopt, Cosopt Multi
- Romania · Cosopt, Cosopt Fără Conservant
- Sweden · Cosopt, Cosopt Sine
- Slovenia · Cosopt, Cosopt Brez Konzervansa
- Slovakia · Cosopt, Cosopt Free
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/b7c6d326-4d16-4ca6-bdd9-5fc2441858df GET /v1/drugs/b7c6d326-4d16-4ca6-bdd9-5fc2441858df?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": "Dorzolamide Hydrochloride, Timolol Maleate",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about dorzolamide hydrochloride, timolol maleate.
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.