Dzuveo Laboratoire Aguettant · Authorised · authorised 25 Jun 2018 · ATC N01AH03
Therapeutic indication (EMA)
Dzuveo is indicated for the management of acute moderate to severe pain in adult patients.
Active substance
Sufentanil
- SFDA 5
- US FDA 5
- EMA 2
- Health Canada 2
- Safety 2
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| SUFENTA AMP 5MCG-ML | 5 µ/ml | Solution for injection · Parenteral use | 5 Ampoule | SAR 66.70 | NCE · Prescription | Piramal Critical Care B.V | Valid |
| SUFENTA AMP 5MCG-ML | 5 µ/ml | Solution for injection · Parenteral use | 5 Ampoule | SAR 18.80 | NCE · Prescription | Piramal Critical Care B.V | Valid |
| SUFENTA FORTE AMP 50MCG-ML | 50 µ/ml | Solution for injection · Parenteral use | 5 Ampoule | SAR 191.65 | NCE · Prescription | Piramal Critical Care B.V | Valid |
| SUFUNTANIL- HAMELN 5MCG-ML SOLU. FOR INJ | 5 µ/ml | Solution · Parenteral use | 5 Ampoule | SAR 13.15 | Generic · Prescription | HAMELN PHARMACEUTICALS | Withdrawn by MAH · Not Marketed |
| SUFUNTANIL- HAMELN 5MCG-ML SOLU. FOR INJ | 5 µ/ml | Solution · Parenteral use | 5 Ampoule | SAR 52.60 | Generic · Prescription | HAMELN PHARMACEUTICALS | Withdrawn by MAH · Not Marketed |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 |
|---|---|---|---|---|---|
| SUFENTA PRESERVATIVE FREE | EQ 0.05MG BASE/ML | injectable · injection | RISING | Prescription | 4 May 1984 |
| SUFENTANIL CITRATE | EQ 0.05MG BASE/ML | injectable · injection | HOSPIRA | Prescription | 11 Dec 1996 |
| SUFENTANIL CITRATE | EQ 0.05MG BASE/ML | injectable · injection | HIKMA PHARMS | Discontinued | 15 Dec 1995 |
| DSUVIA | EQ 0.03MG BASE | tablet · sublingual | VERTICAL PHARMS | Discontinued | 2 Nov 2018 |
| SUFENTANIL CITRATE | EQ 0.05MG BASE/ML | injectable · injection | WATSON LABS | Discontinued |
EMA European Union — centrally authorised medicines
Zalviso FGK Representative Service GmbH · Withdrawn · authorised 18 Sep 2015 · ATC N01AH03
Therapeutic indication (EMA)
Zalviso is indicated for the management of acute moderate to severe post-operative pain in adult patients.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| SUFENTANIL CITRATE INJECTION USP | 02244147 | 50 MCG / ML | SOLUTION · INTRAVENOUS; EPIDURAL | SANDOZ CANADA INCORPORATED |
| SUFENTANIL CITRATE INJECTION USP | 02442213 | 50 MCG / ML | SOLUTION · INTRAVENOUS; EPIDURAL | STERIMAX INC |
Safety signals and safety-related labeling changes
- US FDA 22 Dec 2025 SUFENTA PRESERVATIVE FREE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Dec 2025 DSUVIA — 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
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.