Germany· DE-A57-c53c97b7fda6614a
Agomelatin Neuraxpharm
A medicinal product containing agomelatine, registered in Germany by Neuraxpharm Arzneimittel Gmbh.
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
- Agomelatine
- Manufacturer
- Neuraxpharm Arzneimittel Gmbh
- 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
Agomelatine in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainAGLONEX 25 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGAccord Healthcare S.L.U.
- United KingdomAgomelatine 25mg tabletsDE Pharmaceuticals
- NetherlandsAgomaval 25 mg, filmomhulde tablettenKrka d.d., Novo mesto
- SwitzerlandAgomelatin Servier
- FranceAGOMELATINE BIOGARAN 25 mg, comprimé pelliculéBIOGARAN
- PolandAgolekPrzedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
- CzechiaVALDOXANLes Laboratoires Servier, Suresnes cedex
- FinlandAgomelatine AnpharmAnpharm Przedsiebiorstwo Farmaceutyczne S.A.
Authorised across Europe · EMA
The same active substance is authorised in 21 EEA countries. Names it is sold under:
- Austria · Agogerolan, Agomelatin Genericon
- Bulgaria · Агомелатин G.L. Pharma
- Czechia · Agomelatin +pharma, Agomelatine G.L.Pharma
- Denmark · Agomelatin Glenmark, Agomelatin Stada
- Estonia · Lamegom
- Spain · Agomelatina Aurovitas Spain, Agomelatina Qualigen
- Finland · Agomelatine Stada, Agomelatine Viatris
- France · Agomelatine Biogaran, Agomelatine Eg
- United Kingdom (Northern Ireland) · Agomelatine Accord, Agomelatine Neuraxpharm
- Hungary · Agomelatin Teva, Agomelatine Anpharm
- Ireland · Agomelatine Viatris
- Iceland · Agomelatine Stada, Valdoxan
- Liechtenstein · Valdoxan
- Lithuania · Agomelatine Anpharm, Lamegom
- Malta · Agomaval
- Netherlands · Agomaval, Agomelatine Accord
- Norway · Valdoxan
- Poland · Agolek, Agomelatine +pharma
- Portugal · Agomelatina Ciclum, Agomelatina Generis
- Sweden · Agomelatin Glenmark, Agomelatine Stada
- Slovakia · Agomelatín Stada, Agomelatine G.L. Pharma
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/4a2041de-ec55-4318-ae9c-fd1c138ad66f GET /v1/drugs/4a2041de-ec55-4318-ae9c-fd1c138ad66f?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": "Oral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Agomelatine",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about agomelatine.
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.