Marketing-authorisation holder
Santhera Pharmaceuticals (Deutschland) GmbH
6 medicines in 4 countries, as authorisation holder.
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Marketing-authorisation holder
6 medicines in 4 countries, as authorisation holder.
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Groups are put together by Prognia from the names regulators publish and from company links; they are not an official corporate structure.
Every medicine in the registers under its name, current ones first.
6 medicines
| Medicine | Substance | Country | Status | Authorised |
|---|---|---|---|---|
| AGAMREESospensione orale | Vamorolone | Italy | Authorised | |
| Agamree | Vamorolone | EU (EMA) | Authorised | 2023 |
| AGAMREE 40 mg/ml suspensie voor oraal gebruikSuspensie voor oraal gebruik | Vamorolone | Netherlands | Authorised | 2023 |
| Puldysa | Idebenone | EU (EMA) | Refused | |
| Raxone | Idebenone | EU (EMA) | Refused | |
| RAXONE 150 mg150mg · Compr. film. | Idebenone | Romania | unknown |
Where it holds or makes medicines, with how many are current.
| Country | Medicines | Current | Past | Companies |
|---|---|---|---|---|
| European Union (EMA) | 3 | 1 | 2 | CompaniesAll medicines |
| Italy | 1 | 1 | 0 | CompaniesAll medicines |
| Netherlands | 1 | 1 | 0 | CompaniesAll medicines |
| Romania | 1 | 0 | 1 | CompaniesAll medicines |
Also in the registers of United Kingdom
The ATC groups most of its medicines belong to, largest first.
The active substances in most of its medicines.
How the registers spell it, normalised: legal forms, accents and capitals removed.
Compiled by Prognia from the public medicine and company registers below. Logos are not used.
Source: European Medicines Agency (EPAR data).
Licence: EMA reuse policy (source acknowledgement required)
Medicines and Healthcare products Regulatory Agency (MHRA), GOV.UK; Category 1 list; publication updated 25 August 2026; acquired 2026-10-15T08:18:47.757811+00:00; original workbook cells and factual authorization/holder projections adapted under Open Government Licence v3.0.
Licence: Open Government Licence v3.0; exact Crown copyright 2026 publication grant
Agenzia Italiana del Farmaco (AIFA); https://drive.aifa.gov.it/farmaci/confezioni_fornitura.csv; HTTP Last-Modified Mon, 12 Oct 2026 23:02:44 GMT; acquired 2026-10-13T17:21:16.224007+00:00; native fields retained, source identifier and role projections are adaptations.
Licence: CC BY 4.0; AIFA published open-data catalog
College ter Beoordeling van Geneesmiddelen, Geneesmiddeleninformatiebank metadata, source update 07-10-2026; downloaded 08-10-2026; factual adaptation.
Licence: Conditional noncreative administrative factual metadata; no dataset-wide CC0 claim
Ministerul Sănătății, Catalogul public naţional al preţurilor, 18 iunie 2021, downloaded 2026-10-08 from data.gov.ro; CC BY 4.0; structured factual adaptation, code whitespace trimmed only where explicitly recorded.
Licence: Creative Commons Attribution 4.0 International (CC BY 4.0)
Report an error or request removalCorrections from the company itself are welcome.