Active substances
Bismuth subcitrate + Metronidazole + Tetracycline
- US FDA 3
- UK MHRA 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PYLERA | 140MG;125MG;125MG | capsule · oral | LABS JUVISE | Prescription | 28 Sep 2006 |
| BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | 140MG;125MG;125MG | capsule · oral | PH HEALTH | Prescription | 6 Mar 2023 |
| BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | 140MG;125MG;125MG | capsule · oral | INGENUS PHARMS LLC | Prescription | 3 Jul 2023 |
UK MHRA United Kingdom — marketing authorisations
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| PYLERA 140 MG/125 MG/125 MG CAPSULES | PL 43311/0001 | LABORATOIRES JUVISE PHARMACEUTICALS | POM |
Components
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.