Active substance
Phenprocoumon
- US FDA 1
- Safety 5
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| LIQUAMAR | 3MG | tablet · oral | ORGANON USA INC | Discontinued | 30 Dec 1957 |
Safety signals and safety-related labeling changes
- EMA PRAC 12 Apr 2018 PRAC signal: Risk of birth defects and foetal loss following first trimester exposure as a function of the time of withdrawal
Action for MAH: update of the product information: Yes - EMA PRAC 30 Nov 2017 PRAC signal: Risk of birth defects and foetal loss following first trimester exposure as a function of the time of withdrawal
Action for MAH: update of the product information: No - EMA PRAC 9 Jun 2017 PRAC signal: Risk of birth defects and foetal loss following first trimester exposure as a function of the time of withdrawal
Action for MAH: update of the product information: No - EMA PRAC 1 Dec 2016 PRAC signal: Calciphylaxis
Action for MAH: update of the product information: Yes - EMA PRAC 8 Jul 2016 PRAC signal: Calciphylaxis
Action for MAH: update of the product information: No
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.