Spain· ES:84099
AUDALIS 40 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
A medicinal product containing atomoxetina, registered in Spain by Medice Arzneimittel Puetter Gmbh & Co. Kg.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- atomoxetina
- Manufacturer
- Medice Arzneimittel Puetter Gmbh & Co. Kg
- 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
Atomoxetina in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- PolandAtomoksetyna MediceMedice Arzneimittel Puetter GmbH & Co. KG
- CzechiaATOFABG.L. Pharma GmbH, Lannach
- United StatesatomoxetineNorthstar Rx LLC
- United KingdomATOMAID 100mg capsulesDr Reddy's Laboratories (UK) Ltd
- SwedenAtomoxetin Actavis 10 mg Kapsel, hårdActavis Group PTC ehf.
- NorwayAtomoxe 1a pharma1 A Pharma
- CanadaAPO-ATOMOXETINEAPOTEX INC
- FinlandAtomoxetin AmaroxAmarox Pharma B.V.
Authorised across Europe · EMA
The same active substance is authorised in 24 EEA countries. Names it is sold under:
- Austria · Atofab, Atomoxetin Amarox
- Belgium · Strattera
- Bulgaria · Atofab
- Cyprus · Strattera
- Czechia · Atofab, Atominex
- Germany · Agakalin, Atama
- Denmark · Atomoxetin Amarox, Atomoxetin Glenmark
- Estonia · Atominex
- Finland · Atomoxetin Orion, Atomoxetine Accord
- United Kingdom (Northern Ireland) · Atomaid, Atomoxetine
- Greece · Atama
- Croatia · Attoxem
- Hungary · Atomoxetin Amarox, Bitinex
- Ireland · Atomoxetine Accord, Atomoxetine Azure
- Iceland · Atomoxetin Actavis, Atomoxetin Medical Valley
- Malta · Atomoxetina Generis, Atomoxetine Aurobindo
- Netherlands · Atofab, Atomoxetine Accord
- Norway · Atomoxetin Orion, Atomoxetine Accord
- Poland · Atomoksetyna Medice, Auroxetyn
- Portugal · Atomoxetina Generis, Atomoxetina Macleods
- Romania · Atofab, Atomoxetin Accord
- Sweden · Atomoxetin Actavis, Atomoxetin Amarox
- Slovenia · Atomoksetin Accord, Strattera
- Slovakia · Atofab, Atominex
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/2d0baafa-535f-4920-a690-34c5cb4a2502 GET /v1/drugs/2d0baafa-535f-4920-a690-34c5cb4a2502?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\":1556614357000,\"rev\":1629703203000}",
"nregistro": "84099",
"substance": "atomoxetina"
}See everything about atomoxetina.
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.