Germany· DE-A57-a5f17b08bac51158
Nisita Mineralische
A medicinal product containing sodium hydrogen carbonate, sodium chloride, registered in Germany by Engelhard 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
- Sodium Hydrogen Carbonate, Sodium Chloride
- Manufacturer
- Engelhard 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
Sodium hydrogen carbonate, sodium chloride in 4 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesAll natural Saline PacketsFOODHOLD U.S.A.
- United KingdomSodium bicarbonate 1.5% / Sodium chloride 1.5% irrigation solution 250ml bottlesSpecial Order
- CanadaBICART SELECT COMBI-PAKVANTIVE ULC
- FinlandBicaflac BufferB. Braun Avitum AG
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- Greece · Hdf 501/Bic
- Italy · Soluzione Per Emodiafiltrazione
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/4910d93f-ad60-4adf-b6e5-4289b3c865d9 GET /v1/drugs/4910d93f-ad60-4adf-b6e5-4289b3c865d9?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": "Nasal Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Sodium Hydrogen Carbonate, Sodium Chloride",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about sodium hydrogen carbonate, sodium chloride.
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.