Active substance
Dinoprostone
- SFDA 8
- US FDA 3
- Health Canada 1
- WHO EML 1
- Safety 3
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| PROPESS 10MG VAGINAL DELIVERY SYSTEM | 10 mg | Vaginal delivery system · Vaginal use | 1 Blister | SAR 210.05 | NCE · Prescription | FERRING Gmph | Valid |
| PROSTIN E2 0.5ML I.V.AMP | 10 mg/ml | Concentrate for solution for infusion · Intravenous use | 1 Ampoule | SAR 112.60 | NCE · Prescription | PFIZER | Valid |
| PROSTIN E2 0.75ML AMP | 1 mg | Concentrate for solution for infusion · Intravenous use | 1 Ampoule | SAR 46.90 | NCE · Prescription | PFIZER | Valid |
| PROSTIN E2 1MG VAGINAL GEL IN APPLICATOR | 1 mg | Vaginal gel · Vaginal use | 1 Vaginal Sponge Applicator | SAR 68.35 | NCE · Prescription | PFIZER SA | Valid |
| PROSTIN E2 2MG VAGINAL GEL IN APPLICATOR | 2 mg | Vaginal gel · Vaginal use | 1 Applicator | SAR 83.00 | NCE · Prescription | PFIZER SA | Valid |
| PROSTIN E2 VAGINAL TAB. 3MG | 3 mg | Vaginal tablet · Vaginal use | 4 Blister | SAR 174.05 | NCE · Prescription | Pfizer S.A | Valid |
| PREPIDIL 0.5MG GEL IN 3G SYRINGE | 0.5 mg | Injection · Vaginal use | 1 Pre-filled syringe | SAR 71.85 | NCE · Prescription | PFIZER | Withdrawn by MAH · Not Marketed |
| PROSTIN E2 TAB 0.5 MG | 0.5 mg | Tablet · Oral use | 10 Blister | SAR 100.10 | NCE · Prescription | PHARMACIA UPJOHN | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
MATERNAL AND CHILD HEALTHCARE- PERINATAL,INTRAPARTUM AND POSTPARTUM CARE
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PREPIDIL | 0.5MG/3GM | gel · endocervical | PFIZER | Prescription | 9 Dec 1992 |
| CERVIDIL | 10MG | insert, extended release · vaginal | FERRING PHARMS INC | Prescription | 30 Mar 1995 |
| PROSTIN E2 | 20MG | suppository · vaginal | PFIZER | Discontinued | 23 Aug 1977 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| CERVIDIL | 02231047 | 10 MG / INSERT | INSERT · VAGINAL | FERRING INC |
WHO WHO Model List of Essential Medicines (2025)
- 22.7. Medicines administered to the neonate [c] · complementary
Therapeutic equivalent to alprostadil (prostaglandin E1) for Other specified congenital anomaly of great arteries including arterial duct
Safety signals and safety-related labeling changes
- US FDA 7 Jul 2020 CERVIDIL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 5 Jul 2017 PREPIDIL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions - US FDA 5 Jul 2017 PROSTIN E2 — safety-related labeling change
Labeling sections changed: Warnings and Precautions
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.