Germany· DE-A57-0df4610f726fb795
Azyter
A medicinal product containing azithromycin dihydrate, registered in Germany by Laboratoires Thea.
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
- Azithromycin Dihydrate
- Manufacturer
- Laboratoires Thea
- 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
Azithromycin dihydrate in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesazithromycinREMEDYREPACK INC.
- CzechiaAZITHROMYCIN VIATRISMylan Ireland Limited, Dublin
- FinlandAmzolynicMacure Pharma ApS
- BelgiumAzithromed 250 mg3DDD Pharma
- IrelandAzithromycin Clonmel 250 mg film-coated tabletsClonmel Healthcare Ltd
- NorwayAzitromaxPfizer AS
- SwedenAzitromax 40 mg/ml Pulver till oral suspensionPfizer AB
Authorised across Europe · EMA
The same active substance is authorised in 28 EEA countries. Names it is sold under:
- Austria · Azithromycin Dr. Friedrich Eberth, Azithromycin Sandoz
- Belgium · Azithromycin Teva, Azithromycine Sandoz
- Bulgaria · Aзитер, Азитрокс
- Cyprus · Azyter, Zithromax
- Czechia · Azitrox, Azyter
- Denmark · Azyter
- Estonia · Azitrox
- Spain · Aratro, Azitromicina Almus
- Finland · Azithromycin Sandoz, Azyter
- France · Azadose, Azithromycine Arrow Lab
- United Kingdom (Northern Ireland) · Azithromycin, Azithromycin Manx Healthcare
- Greece · Azivirus, Azyter
- Croatia · Azitromicin Sandoz, Azyter
- Hungary · Azi, Azithromycin 1 A Pharma
- Ireland · Azyter, Zithromax
- Iceland · Azyter
- Italy · Azacid, Aziprome
- Lithuania · Azitrox
- Luxembourg · Azithromycin Ratiopharm, Azyter
- Malta · Azitredil, Zinfect
- Netherlands · Azithromycin Dihydrate Aurobindo, Azitromycine Sandoz
- Norway · Azitromax, Azyter
- Poland · Azitrolek, Azyter
- Portugal · Azitromicina Alter, Azitromicina Azevedos
- Romania · Azitromicină Arena, Azitromicina Sandoz
- Sweden · Azitromax, Azyter
- Slovenia · Azyter, Sumamed
- Slovakia · Azithromycin Sandoz, Azitromycin Viatris
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/ee47c150-09b3-4c1b-9617-2ef98716c2a1 GET /v1/drugs/ee47c150-09b3-4c1b-9617-2ef98716c2a1?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": "Azithromycin Dihydrate",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about azithromycin dihydrate.
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.