Regulatory PathRegulatory requirements compared

Active substance

Benzathine penicillin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
RETARPEN 1.2MEGA U.WITH SOLVENT1200000 IUPowder and solvent for suspension for injection · Intramuscular use1 VialSAR 6.45NCE · PrescriptionSANDOZValid
RETARPEN 2.4MEGA U. VIAL+SOLVENT2400000 IUSolution · Intramuscular use1 VialSAR 11.60NCE · PrescriptionSANDOZWithdrawn by MAH · Not Marketed
RETARPEN 600000U+ SOLVENT VIAL600000 IUSolution · Intramuscular use1 VialSAR 3.60NCE · PrescriptionSANDOZWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

BACTERIAL SKIN INFECTIONS - ERYSIPELAS AND CELLULITIS; BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; ENDOCARDITIS; MATERNAL AND CHILD HEALTHCARE- PROPHYLAXIS FOR P-PROM, DELIVERY BY C-SECTION, GROUP B STREPTOCOCCUS, SYPHILIS IN PREGNANCY; PHARYNGITIS; SYPHILIS

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.