US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| UREAPHIL | 40GM/VIAL | injectable · injection | HOSPIRA | Discontinued | 5 Oct 1966 |
| STERILE UREA | 40GM/VIAL | injectable · injection | HOSPIRA | Discontinued | 22 Dec 1976 |
EMA European Union — centrally authorised medicines
Helicobacter Test INFAI INFAI, Institut für biomedizinische Analytik NMR-Imaging GmbH · Authorised · authorised 14 Aug 1997 · ATC V04CX
Therapeutic indication (EMA)
Helicobacter Test INFAI may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in: adults; adolescents, who are likely to have peptic ulcer disease. Helicobacter Test INFAI for children aged three to 11 years may be used for in vivo diagnosis of gastrduodenal Helicobacter pylori infection: for the evaluation of the success of eradication treatment, or; when invasive tests cannot be performed, or; when there are discordant results arising from invasive tests. This medicinal product is for diagnostic use only.
Pylobactell Richen Europe S.R.L · Authorised · authorised 7 May 1998 · ATC V04CX
Therapeutic indication (EMA)
This medicinal product is for diagnostic use only. For in vivo diagnosis of gastroduodenal Helicobacter pylori (H. pylori) infection.
Pylori-Chek Alimenterics B.V. · Withdrawn · authorised 15 Jun 1998 · ATC V04CX
Therapeutic indication (EMA)
Pylori-Chek may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection.
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | UREA 40% CREAM | $1.04865 | per GM | 23 Sep 2026 |
| US NADAC | UREA 40% CREAM | $0.26873 | per GM | 23 Sep 2026 |
| NHS Drug Tariff | Urea 5% cream | £14.54 | 50 ml | 1 Oct 2026 |
| NHS Drug Tariff | Urea 5% cream | £5.78 | 75 ml | 1 Oct 2026 |
| NHS Drug Tariff | Urea 5% scalp application | £11.37 | 100 ml | 1 Oct 2026 |
| NHS Drug Tariff | Urea [13-C] 45mg oral powder breath test kit sugar free | £19.20 | 1 kit | 1 Oct 2026 |
| NHS Drug Tariff | Urea [13-C] 50mg tablets breath test kit | £21.25 | 1 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Urea [13-C] 75mg oral powder breath test kit sugar free | £21.70 | 1 kit | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 13.4. Dermatological medicines > Medicines affecting skin differentiation and proliferation · core
Xerosis cutis or asteatosis
Local > Topical > Cream: 10%; 5% | Local > Topical > Ointment: 10%; 5% - 13.6. Dermatological medicines > Moisturizers · core
Atopic eczema
Local > Topical > Cream: 5 per %
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), 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.