Germany· DE-A57-b9af7caf4e6fa2d3
Rotop - Neurospect
A medicinal product containing exametazime, registered in Germany by Rotop Pharmaka 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
- Exametazime
- Manufacturer
- Rotop Pharmaka Gmbh
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 23, 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
Exametazime in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaBRAIN-SPECT KITMedi-Radiopharma Kft., Érd
- CanadaCERETECGE HEALTHCARE CANADA INC
- United KingdomCeretec 500microgram kit for radiopharmaceutical preparationGE Healthcare Ltd
- NetherlandsCeretec 0,5 mg kit voor radiofarmaceutische preparaatGE Healthcare B.V.
- SpainCERETEC 500 MICROGRAMOS EQUIPO DE REACTIVOS PARA PREPARACIÓN RADIOFARMACÉUTICAGe Healthcare Bio-Sciences, S.A.U.
- SwedenCeretec Stabilised 0,50 mg Beredningssats för radioaktivt läkemedelGE Healthcare AS
- FinlandCeretecGE Healthcare AS
- FranceCERESTAB 500 microgrammes, trousse radiopharmaceutiqueGE HEALTHCARE
Authorised across Europe · EMA
The same active substance is authorised in 19 EEA countries. Names it is sold under:
- Austria · Medi-Exametazim
- Belgium · Exametazime Radiopharmacy Laboratory, Stabilised Ceretec
- Czechia · Brain - Spect Kit, Exametazim Radiopharmacy Laboratorium
- Denmark · Ceretec, Medi-Exametazim
- Spain · Ceretec, Ceretec Estabilizado
- Finland · Ceretec
- France · Cerestab, Ceretec
- United Kingdom (Northern Ireland) · Ceretec, Stabilised Ceretec
- Greece · Ceretec
- Hungary · Brain-Spect, Ceretec
- Italy · Ceretec, Exametascan
- Lithuania · Ceretec
- Luxembourg · Medi-Exametazim, Stabilised Ceretec
- Netherlands · Ceretec, Exametazime Radiopharmacy Laboratory
- Norway · Ceretec, Exametazime Radiopharmacy Laboratory
- Portugal · Exametazima Radiopharmacy
- Sweden · Ceretec Stabilised, Exametazim Radiopharmacy Laboratory
- Slovenia · Eksametazim Radiopharmacy Laboratory
- Slovakia · Ceretec
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/d3d88415-0e63-455a-953a-565155cccea0 GET /v1/drugs/d3d88415-0e63-455a-953a-565155cccea0?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": "Intravenous Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Exametazime",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about exametazime.
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.