Active substance
Roxithromycin
- SFDA 4
- Safety 6
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| ROXAMED | 150 mg | Film-coated tablet · Oral use | 10 Blister | SAR 29.75 | Generic · Prescription | DAR ALDAWA | Valid |
| ROMAC 150MG F.C. TABLETS | 150 mg | Film-coated tablet · Oral use | 10 Blister | SAR 17.65 | Generic · Prescription | The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM) | Withdrawn by MAH · Not Marketed |
| ROMAC 300MG F.C. TABLETS | 300 mg | Film-coated tablet · Oral use | 10 Blister | SAR 29.90 | Generic · Prescription | The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM) | Withdrawn by MAH · Not Marketed |
| RULID 150MG TAB | 150 mg | Tablet · Oral use | 10 Blister | SAR 45.00 | NCE · Prescription | SANOFI WINTHROP INDUSTRIE | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
TRAVEL RELATED INFECTIONS-TREATMENT
Safety signals and safety-related labeling changes
- EMA PRAC 29 Sep 2017 PRAC signal: Acute generalised exanthematous pustulosis (AGEP)
Action for MAH: update of the product information: Yes - EMA PRAC 5 May 2017 PRAC signal: Acute generalised exanthematous pustulosis (AGEP)
Action for MAH: update of the product information: No - EMA PRAC 7 Feb 2013 PRAC signal: Hearing disorders
Action for MAH: update of the product information: Yes - EMA PRAC 7 Feb 2013 PRAC signal: Rhabdomyolysis secondary to interaction with statins
Action for MAH: update of the product information: Yes - EMA PRAC 5 Sep 2012 PRAC signal: Hearing disorders
Action for MAH: update of the product information: Yes - EMA PRAC 5 Sep 2012 PRAC signal: Rhabdomyolysis secondary to interaction with statins
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.