Germany· DE-A57-61cfc1f2f3fae053
Fotil
A medicinal product containing timolol maleate, pilocarpine hydrochloride, 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
- Timolol Maleate, Pilocarpine Hydrochloride
- 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
Timolol maleate, pilocarpine hydrochloride in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandFotilSanten Oy
- NorwayFotilSanten Oy
- SwedenFotil 5 mg/ml + 20 mg/ml Ögondroppar, lösningSanten Oy
- CzechiaFOTILSanten OY, Tampere
- IcelandFotil ForteSanten Oy*
Authorised across Europe · EMA
The same active substance is authorised in 11 EEA countries. Names it is sold under:
- Bulgaria · Фотил, Фотил Форте
- Czechia · Fotil, Fotil Forte
- Denmark · Fotil, Fotil Forte
- Finland · Fotil, Fotil Forte
- Hungary · Fotil, Fotil Forte
- Iceland · Fotil Forte
- Italy · Equiton
- Lithuania · Fotil
- Latvia · Fotil
- Norway · Fotil, Fotil Forte
- Sweden · Fotil, Fotil Forte
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/043d0d75-d5f3-45d7-b6d9-ac8160bb6331 GET /v1/drugs/043d0d75-d5f3-45d7-b6d9-ac8160bb6331?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": "Timolol Maleate, Pilocarpine Hydrochloride",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about timolol maleate, pilocarpine 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.