Spain· ES:1181306002
SYMKEVI 50 mg/75 mg COMPRIMDOS RECUBIERTOS CON PELICULA
A ivacaftor and tezacaftor product containing tezacaftor + ivacaftor, registered in Spain by Vertex Pharmaceuticals (Ireland) Limited. The same ATC class is registered in 15 of our 19 countries.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
Where it is registered
Ivacaftor and tezacaftor is registered in 15 of 19 countries.
Countries holding a registration under ATC R07AX31 (ivacaftor and tezacaftor), each read from that country’s own register.
- This record: Spain, from AEMPS CIMA (Spain)
- 10 of them publish a price we can compare per daily dose
Ivacaftor and tezacaftor · ATC R07AX31
15 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Italyprice
- Netherlands
- Norwayprice
- Polandprice
- Spainprice
- Switzerlandprice
- United Kingdom
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- tezacaftor + ivacaftor
- Manufacturer
- Vertex Pharmaceuticals (Ireland) Limited
- Country
- Spain (ES)
- ATC code
- R07AX31
- ATC class
- Ivacaftor and tezacaftor
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 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
Ivacaftor and tezacaftor in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandSymkeviOrifarm Oy
- SwitzerlandSymdeko 100 mg / 150 mg und 150 mg, FilmtablettenVertex Pharmaceuticals (CH) GmbH
- CzechiaSYMKEVIVertex Pharmaceuticals (Ireland) Limited, Dublin
- SwedenSymkevi 100 mg/150 mg Filmdragerad tablettVertex Pharmaceuticals Ireland Ltd
- NorwaySymkeviVertex Pharmaceuticals (Ireland) Limited
- PolandSymkeviVertex Pharmaceuticals (Ireland) Ltd.
- FranceSYMKEVI 100 mg/150 mg, comprimé pelliculéVERTEX PHARMACEUTICALS (EUROPE) ROYAUME-UNI)
- United KingdomSymkevi 100mg/150mg tabletsVertex Pharmaceuticals (Europe) Ltd
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Symkevi
- Liechtenstein · Symkevi
- Norway · Symkevi
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 AEMPS CIMA (Spain). 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/c63759b8-abbb-4840-9be4-3a411b8a4c6c GET /v1/drugs/c63759b8-abbb-4840-9be4-3a411b8a4c6c?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.
{
"cpresc": "Uso Hospitalario",
"estado": "{\"aut\":1611254121000}",
"nregistro": "1181306002",
"substance": "tezacaftor + ivacaftor"
}See everything about ivacaftor and tezacaftor.
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.