Active substance
Remifentanil
- SFDA 8
- US FDA 4
- Health Canada 2
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| REMIFENTANIL MEDIS 1 MG VIAL | 1 mg | Powder for solution for injection/infusion · Intravenous use | 5 Vial | SAR 79.20 | Generic · Prescription | LES LABORATOIRES MEDIS | Valid |
| REMIFENTANIL MEDIS 5 MG VIAL | 5 mg | Powder for solution for injection/infusion · Intravenous use | 5 Vial | SAR 306.05 | Generic · Prescription | LES LABORATOIRES MEDIS | Valid |
| ULTIVA 1MG VIAL(LYOPHILIZED) | 1 mg | Powder for concentrate for solution for infusion · Intravenous use | 5 Vial | SAR 82.10 | NCE · Prescription | Aspen Pharma Trading Limited | Valid |
| ULTIVA 2MG VIAL(LYOPHILIZED) | 2 mg | Powder for concentrate for solution for infusion · Intravenous use | 5 Vial | SAR 155.50 | NCE · Prescription | Aspen Pharma Trading Limited | Valid |
| ULTIVA 5MG VIAL(LYOPHILIZED) | 5 mg | Powder for concentrate for solution for infusion · Intravenous use | 5 Vial | SAR 369.35 | NCE · Prescription | Aspen Pharma Trading Limited | Valid |
| ULTIVA 1MG VIAL(LYOPHILIZED) | 1 mg | Solution for injection · Intravenous use | 5 Vial | SAR 100.65 | NCE · Prescription | GLAXO | Withdrawn by MAH · Not Marketed |
| ULTIVA 2MG VIAL(LYOPHILIZED) | 2 mg | Solution for injection · Intravenous use | 5 Vial | SAR 155.50 | NCE · Prescription | GLAXO | Withdrawn by MAH · Not Marketed |
| ULTIVA 5MG VIAL(LYOPHILIZED) | 5 mg | Solution for injection · Intravenous use | 5 Vial | SAR 388.80 | NCE · Prescription | GLAXO | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ANESTHESIA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ULTIVA | EQ 1MG BASE/VIAL; EQ 2MG BASE/VIAL; EQ 5MG BASE/VIAL | injectable · injection | MYLAN INSTITUTIONAL | Prescription | 12 Jul 1996 |
| REMIFENTANIL HYDROCHLORIDE | EQ 1MG BASE/VIAL; EQ 2MG BASE/VIAL; EQ 5MG BASE/VIAL | injectable · injection | FRESENIUS KABI USA | Prescription | 16 Jan 2018 |
| REMIFENTANIL HYDROCHLORIDE | EQ 1MG BASE/VIAL; EQ 2MG BASE/VIAL; EQ 5MG BASE/VIAL | injectable · injection | HIKMA PHARMS | Prescription | 13 Oct 2020 |
| REMIFENTANIL HYDROCHLORIDE | EQ 1MG BASE/VIAL; EQ 2MG BASE/VIAL; EQ 5MG BASE/VIAL | injectable · injection | NIVAGEN | Prescription | 28 Jun 2024 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| REMIFENTANIL HYDROCHLORIDE FOR INJECTION | 02366460 | 1 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | STERIMAX INC |
| REMIFENTANIL HYDROCHLORIDE FOR INJECTION | 02366479 | 2 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | STERIMAX INC |
Safety signals and safety-related labeling changes
- US FDA 22 Dec 2025 ULTIVA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.