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Spain· ES:80552

DULOXETINA APOTEX AG 60 MG CAPSULAS DURAS GASTRORRESISTENTES EFG

A medicinal product containing duloxetina, registered in Spain by Apotex Europe B.V..

Checked against AEMPS CIMA (Spain) on

Informational only — not a medical device.

SOURCE REGISTER · ESAEMPS CIMA (Spain)normalisedDULOXETINA APOTEX AG 60 MG CAPSULAS D…ATC—REGISTER NO.ES:80552PACKS LISTED0CHECKEDJune 3, 2026

The record

At a glance

AEMPS CIMA (Spain)
Active substance
duloxetina
Manufacturer
Apotex Europe B.V.
Country
Spain (ES)
ATC code
—
Reimbursed
Not published by this register
Source register
AEMPS CIMA (Spain)
Last checked
June 3, 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

Duloxetina in 17 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All duloxetina products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Dulasolan, Duloxetin +pharma
  • Belgium · Duloxetin Ab, Duloxétine Ab
  • Bulgaria · Dulasolan, Duxet
  • Cyprus · Dulox, Duloxetine Accord
  • Czechia · Dolyxan, Dulasolan
  • Germany · Dulasolan, Duloxalta
  • Denmark · Aritavi, Duciltia
  • Estonia · Dulsevia, Onelar
  • Finland · Duloxetin Stada, Duloxetine Accord
  • France · Duloxetine Accord, Duloxetine Almus
  • United Kingdom (Northern Ireland) · Depalta, Duciltia
  • Greece · Duciltia, Duloxetine Liconsa
  • Croatia · Dolyxan, Duloksetin Pliva
  • Hungary · Duciltia, Dulodet
  • Ireland · Duloxetine Accord, Duloxetine Clonmel
  • Iceland · Aritavi, Cymbalta
  • Italy · Alikres, Dulex
  • Liechtenstein · Cymbalta, Duloxetine Lilly
  • Lithuania · Dulsevia
  • Luxembourg · Duloxetin Ab, Duloxetine Liconsa
  • Latvia · Dulsevia
  • Malta · Onelar
  • Netherlands · Dulasolan, Dulodet
  • Norway · Cymbalta, Duloxetin Krka
  • Poland · Aurodulox, Depratal
  • Portugal · Duloxetina Alter, Duloxetina Amperlem
  • Romania · Dozzex, Duloxetină Dr. Reddy's
  • Sweden · Aritavi, Dulmis
  • Slovenia · Duloksetin Sandoz, Dulsevia
  • Slovakia · Duloxetin Krka, Duloxetin Krka, D.D., Novo Mesto

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/ebb28131-27ee-47bd-a34a-b5547cba1df3
GET /v1/drugs/ebb28131-27ee-47bd-a34a-b5547cba1df3?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": "Medicamento Sujeto A Prescripción Médica",
  "estado": "{\"aut\":1452726000000,\"rev\":1633452049000}",
  "nregistro": "80552",
  "substance": "duloxetina"
}

See everything about duloxetina.

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.