Germany· DE-A57-d0006daa1331c0f6
Dexa-Ophtal®
A medicinal product containing dexamethasone sodium phosphate ph. eur., registered in Germany by Dr. Gerhard Mann Chem.-Pharm. Fabrik 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
- Dexamethasone Sodium Phosphate Ph. Eur.
- Manufacturer
- Dr. Gerhard Mann Chem.-Pharm. Fabrik 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
Dexamethasone sodium phosphate ph. eur. in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomDecadron 4mg tabletsCST Pharma Ltd
- United StatesdexamethasoneMajor Pharmaceuticals
- CzechiaDEXAMETHASONE KRKAKrka, d.d., Novo mesto, Novo mesto
- PolandCovexanZakłady Farmaceutyczne POLPHARMA S.A.
- SpainAMEXXINE 1 MG/ML COLIRIO EN SOLUCIONPharmaselect International Beteiligungs Gmbh
- Japanデキサメタゾン日新製薬（山形）
- NetherlandsAxium-Opto 1mg/ml oogdruppels, oplossing in verpakking voor eenmalig gebruikUni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A
- SwedenAxiumopto 1 mg/ml Ögondroppar, lösning i endosbehållareUni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Dexamethason Hcs, Dexamethason Kalceks
- Belgium · Darazon, Dexalis
- Bulgaria · Dexanova, Дeксаметазон Крка
- Cyprus · Axium-Opto, Decadron
- Czechia · Dexamed, Dexamethasone Fmk
- Denmark · Axiumopto, Dexacur
- Estonia · Caltrixan, Dexamethason Krka
- Spain · Amexxine, Dexafree
- Finland · Axiumopto, Dexacur
- France · Aflavis, Dectancyl
- United Kingdom (Northern Ireland) · Dexafree, Dexamethason Glenmark Pharmaceuticals Europe
- Greece · Amelinor, Axium
- Croatia · Darazur, Deksametazon Kalceks
- Hungary · Darazur, Dexamethasone Kalceks
- Ireland · Dexafree, Dexamethasone Activase Pharmaceuticals
- Iceland · Dexametason Abcur, Dexamethason Krka
- Italy · Amexzur, Cortmuper
- Liechtenstein · Neofordex, Ozurdex
- Lithuania · Dexamethason Krka, Dexamethasone Kalceks
- Luxembourg · Dexalis, Dexamethasone Kalceks
- Latvia · Dexamethason Krka, Dexamethasone Kalceks
- Malta · Axium-Opto, Decadron
- Netherlands · Axium-Opto, Dexamethason
- Norway · Dexacur, Dexametason Abcur
- Poland · Covexan, Darazur
- Portugal · Amexzur, Decadron
- Romania · Dexametazonă Fosfat Krka, Dexametazona Krka
- Sweden · Axiumopto, Baxil
- Slovenia · Deksametazon Krka, Deksametazon Medochemie
- Slovakia · Amexxine, Dexametazón Krka
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/2817ec54-db6f-43b7-9f70-396c1e54cc46 GET /v1/drugs/2817ec54-db6f-43b7-9f70-396c1e54cc46?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": "Ocular Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Dexamethasone Sodium Phosphate Ph. Eur.",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about dexamethasone sodium phosphate ph. eur..
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.