Germany· DE-A57-e5da6a2ee12544d1
Atosil N
A medicinal product containing promethazine hydrochloride, registered in Germany by Desitin 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
- Promethazine Hydrochloride
- Manufacturer
- Desitin Arzneimittel Gmbh
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- August 5, 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
Promethazine hydrochloride in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesPhenerganDirect_Rx
- United KingdomPhenergan 10mg tabletsOpella Healthcare UK Ltd
- NetherlandsPromethazine ACE 25 mg/ml, oplossing voor injectieACE Pharmaceuticals B.V.
- SwedenFarghess 25 mg Filmdragerad tablettOmet Pharma AB
- Japanプロメタジン塩酸塩田辺ファーマ
- NorwayPhenerganFrilab
- PolandDipherganBausch Health Ireland Ltd.
- FrancePHENERGAN 2 %, crèmeLABORATOIRES FRILAB
Authorised across Europe · EMA
The same active substance is authorised in 19 EEA countries. Names it is sold under:
- Bulgaria · Aнтиалeрзин
- Cyprus · Promethazine Remedica
- Czechia · Prothazin
- Denmark · Phenergan, Prometazin Actavis
- Spain · Fenergan
- France · Phenergan
- United Kingdom (Northern Ireland) · Phenergan, Phenergan Elixir
- Greece · Fenimezyl, Prugal-Derm
- Hungary · Pipolphen
- Ireland · Phenergan
- Iceland · Phenergan, Prometazin Actavis
- Italy · Alontan Antistaminico, Fadezin
- Malta · Fenazil, Promethazine Remedica
- Netherlands · Promethazine Ace, Promethazine Cf
- Norway · Phenergan
- Poland · Diphergan, Polfergan
- Portugal · Prometazina Basi, Prometazina Medlink
- Sweden · Farghess, Lergigan
- Slovakia · Prothazin
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/d3860c67-db94-4192-a1a2-4ea3ac667a47 GET /v1/drugs/d3860c67-db94-4192-a1a2-4ea3ac667a47?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": "Intramuscular Use, Intravenous Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Promethazine Hydrochloride",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about promethazine hydrochloride.
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.