Active substance
Pefloxacin
- SFDA 1
- Safety 5
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| PEFLACINE 400MG COATED TAB | 400 mg | Coated tablet · Oral use | 10 Blister | SAR 61.40 | NCE · Prescription | sanofi-aventis | Withdrawn by MAH · Not Marketed |
Safety signals and safety-related labeling changes
- EMA PRAC 2 Sep 2021 PRAC signal: Acquired thrombotic thrombocytopenia purpura
Action for MAH: update of the product information: No - EMA PRAC 9 Apr 2021 PRAC signal: Acquired thrombotic thrombocytopenia purpura
Action for MAH: update of the product information: No - EMA PRAC 3 Sep 2020 PRAC signal: Heart valve regurgitation, cervical artery dissection, and aortic aneurysm and dissection
Action for MAH: update of the product information: Yes - EMA PRAC 14 May 2020 PRAC signal: Heart valve regurgitation, cervical artery dissection, and aortic aneurysm and dissection
Action for MAH: update of the product information: No - EMA PRAC 16 Jan 2020 PRAC signal: Heart valve regurgitation
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.