Germany· DE-A57-e91d7befdcbb1d51
Takrozem
A medicinal product containing tacrolimus monohydrate, registered in Germany by Pierre Fabre Medicament.
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
- Tacrolimus Monohydrate
- Manufacturer
- Pierre Fabre Medicament
- 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
Tacrolimus monohydrate in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaADVAGRAFAstellas Pharma Europe B.V., Leiden
- United StatesASTAGRAF XLAstellas Pharma US, Inc.
- SwedenAdoport 0,5 mg Kapsel, hårdUAB BIJON medica
- United KingdomAdoport 0.5mg capsulesSandoz Ltd
- NetherlandsAdport 0,5 mg, capsules, hardEuro Registratie Collectief B.V.
- FinlandAdportSandoz A/S
- SpainADOPORT 0,5 mg CAPSULAS DURAS EFGSandoz Farmaceutica S.A.
- SwitzerlandAdvagraf
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Adport, Dailiport
- Belgium · Adoport, Dailiport
- Bulgaria · Програф
- Cyprus · Prograf, Tacrolimus Accord
- Czechia · Dailiport, Gecrol
- Denmark · Adport, Dailiport
- Estonia · Dailiport, Lebsanan
- Spain · Adoport, Cellmune
- Finland · Adport, Adport,
- France · Adoport, Conferoport
- United Kingdom (Northern Ireland) · Adoport, Ascezo
- Greece · Atodrit-Dermo, Eczatope Derm
- Croatia · Atezyrix, Dermitopic
- Hungary · Prograf, Tacrolimus Stada
- Ireland · Prograf, Tacrolimus Accord
- Iceland · Advagraf, Dailiport
- Italy · Adoport, Carelimus
- Liechtenstein · Advagraf, Envarsus
- Lithuania · Dailiport, Lebsanan
- Luxembourg · Prograft, Sumilor
- Latvia · Dailiport, Lebsanan
- Malta · Prograf
- Netherlands · Adport, Conferoport
- Norway · Adport, Advagraf
- Poland · Cidimus, Dailiport
- Portugal · Adoport, Dermitopic
- Romania · Prograf, Tacrolimus Sandoz
- Sweden · Adport, Adport,
- Slovenia · Adoport, Dailiport
- Slovakia · Atezyrix, Dailiport
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/230233a4-efd9-48ef-b112-5cb2e0b0b5d9 GET /v1/drugs/230233a4-efd9-48ef-b112-5cb2e0b0b5d9?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": "Cutaneous Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Tacrolimus Monohydrate",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about tacrolimus monohydrate.
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.