Germany· DE-A57-baba27e6506a2503
Pylera
A medicinal product containing tetracycline hydrochloride, metronidazole, bismuth subcitrate potassium, registered in Germany by Laboratoires Juvise Pharmaceuticals.
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
- Tetracycline Hydrochloride, Metronidazole, Bismuth Subcitrate Potassium
- Manufacturer
- Laboratoires Juvise Pharmaceuticals
- 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
Tetracycline hydrochloride, metronidazole, bismuth subcitrate potassium in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- PolandPyleraMedezin Sp. z o.o.
- United StatesBismuth Subcitrate Potassium, Metronidazole and Tetracycline HydrochlorideH2-Pharma, LLC
- SpainPYLERA 140 mg/125 mg/125 mg CAPSULASLaboratoires Juvise Pharmaceuticals
- FinlandPyleraLaboratoires Juvise Pharmaceuticals
- SwitzerlandPylera 140 mg/125 mg/125 mg, HartkapselnMedius AG
- IrelandPylera 140 mg/125 mg/125 mg capsules, hardLaboratoires Juvise Pharmaceuticals
- SwedenPylera 140 mg/125 mg/125 mg Kapsel, hårdLaboratoires Juvise Pharmaceuticals
- FrancePYLERA 140 mg/125 mg/125 mg, géluleLABORATOIRES JUVISE PHARMACEUTICALS
Authorised across Europe · EMA
The same active substance is authorised in 22 EEA countries. Names it is sold under:
- Austria · Pylera
- Belgium · Tryplera
- Bulgaria · Pylera
- Czechia · Pylera
- Denmark · Pylera
- Estonia · Pylera
- Spain · Pylera
- Finland · Pylera
- France · Pylera
- United Kingdom (Northern Ireland) · Pylera
- Ireland · Pylera
- Italy · Pylera
- Lithuania · Pylera
- Luxembourg · Tryplera
- Latvia · Pylera
- Malta · Pylera
- Norway · Pylera
- Poland · Pylera
- Portugal · Pylera
- Romania · Pylera
- Sweden · Pylera
- Slovakia · Pylera
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/66a8dd8b-4409-4e72-86f9-96181dfa8178 GET /v1/drugs/66a8dd8b-4409-4e72-86f9-96181dfa8178?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": "Oral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Tetracycline Hydrochloride, Metronidazole, Bismuth Subcitrate Potassium",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about tetracycline hydrochloride, metronidazole, bismuth subcitrate potassium.
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.