Finland· FI-REL-REL774
Theofol Comp
A theophyllin, kombinationen, exkl. psycholeptika product containing theophylline monohydricum + guaifenesin, registered in Finland by Takeda Oy. The same ATC class is registered in 3 of our 19 countries.
Checked against Fimea (Finland) on
Informational only — not a medical device.
Where it is registered
Theophyllin, kombinationen, exkl. psycholeptika is registered in 3 of 19 countries.
Countries holding a registration under ATC R03DA54 (theophyllin, kombinationen, exkl. psycholeptika), each read from that country’s own register.
- This record: Finland, from Fimea (Finland)
- 2 of them publish a price we can compare per daily dose
Theophyllin, kombinationen, exkl. psycholeptika · ATC R03DA54
3 / 19 countries
- Canada
- Finlandprice
- Polandprice
The record
At a glance
Fimea (Finland)- Active substance
- Theophylline monohydricum + Guaifenesin
- Manufacturer
- Takeda Oy
- Country
- Finland (FI)
- ATC code
- R03DA54
- ATC class
- Theophyllin, Kombinationen, exkl. Psycholeptika
- Reimbursed
- Not published by this register
- Source register
- Fimea (Finland)
- Last checked
- September 27, 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
Theophyllin, kombinationen, exkl. psycholeptika in 1 other country
What each register calls a product with the same active substance — salts and hydrates count as the same.
Authorised across Europe · EMA
The same active substance is authorised in 1 EEA country. Names it is sold under:
- Poland · Baladex
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 Fimea (Finland). 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/556774bb-d44d-49ef-be40-1375cd0b6087 GET /v1/drugs/556774bb-d44d-49ef-be40-1375cd0b6087?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.
{
"ddd": "12",
"form": "oraaliliuos",
"route": "Suun kautta",
"ddd_unit": "ED",
"strength": null,
"atc_label": "teofylliini, yhdistelmävalmisteet",
"ma_number": "6088",
"auth_status": "Myyntilupa peruuntunut",
"eu_ma_number": null,
"fimea_rel_id": "REL774",
"authorised_at": "1970-09-16"
}See everything about theophyllin, kombinationen, exkl. psycholeptika.
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.