Remifentanil

Overview

Remifentanil (marketed by Abbott as Ultiva) is a potent ultra short-acting synthetic opioid given to patients during surgery for pain relief and adjunctive to an anaesthetic. Remifentanil is a specific mu-type-opioid receptor agonist which means it reduces sympathetic nervous system tone, and causes respiratory depression and analgesia.

Indication

For use during the induction and maintenance of general anesthesia.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Effects of Dexmedetomidine and Remifentanil on Kidney Injury After Muscle Compression Injury in Rats	2025/07/30	NCT07094165	Not Applicable	Completed	Ankara City Hospital Bilkent
Effect of Remifentanil on Pruritus and Paresthesia of Fospropofol Disodium Anesthesia	2025/07/29	NCT07092384	Not Applicable	Recruiting	Tongji Hospital
Minimal Flow Anesthesia and Infection Risk	2025/07/29	NCT07092046	Not Applicable	Active, not recruiting	Ankara City Hospital Bilkent
Application of Low-dose Muscle Relaxants in Bronchoscopic Interventional Procedures	2025/06/25	NCT07035301	Not Applicable	Recruiting	Harbin Medical University
Effects Of Anaesthesia on Intraocular Pressure in Robotic Prostate Surgery	2025/06/24	NCT07033442	Not Applicable	Completed	Ataturk Training and Research Hospital
Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery	2025/05/06	NCT06958393	Phase 4	Not yet recruiting	Qianfoshan Hospital
Pain Control and Quality of Recovery After Intravenous Methadone Versus Intravenous Remifentanil in Craniotomy Surgery	2025/02/05	NCT06810336	Early Phase 1	Not yet recruiting	University of Virginia
Postoperative Cognitive Dysfunction in Transsphenoidal Pituitary Surgeries	2025/01/27	NCT06793150	Phase 4	Completed	Kocaeli University
The Impact of Low-Dose Esketamine Combined With Ciprofol on the Quality of Early Postoperative Recovery Among Elderly Patients Undergoing Painless Gastroscopy	2024/09/27	NCT06617039	Not Applicable	Active, not recruiting	Northern Jiangsu People's Hospital
Remifentanil and Remimazolam to Limit Patient Movement	2024/09/04	NCT06583811	Not Applicable	Recruiting	Egymedicalpedia

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Remifentanil Hydrochloride	Fresenius Kabi USA, LLC	63323-725	INTRAVENOUS	1 mg in 1 mL	10/4/2019
Ultiva	Mylan Institutional LLC	72078-034	INTRAVENOUS	1 mg in 1 mL	4/15/2022
Ultiva	Mylan Institutional LLC	67457-912	INTRAVENOUS	1 mg in 1 mL	10/21/2019
Ultiva	Mylan Institutional LLC	67457-914	INTRAVENOUS	1 mg in 1 mL	10/21/2019
Ultiva	Mylan Institutional LLC	67457-913	INTRAVENOUS	1 mg in 1 mL	10/21/2019
Remifentanil Hydrochloride	Fresenius Kabi USA, LLC	63323-723	INTRAVENOUS	1 mg in 1 mL	10/31/2019
Ultiva	Mylan Institutional LLC	72078-035	INTRAVENOUS	1 mg in 1 mL	4/15/2022
REMIFENTANIL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	0143-9392	INTRAVENOUS	2 mg in 2 mL	1/1/2024
Remifentanil Hydrochloride	Fresenius Kabi USA, LLC	63323-723	INTRAVENOUS	1 mg in 1 mL	10/4/2019
Ultiva	Mylan Institutional LLC	67457-198	INTRAVENOUS	1 mg in 1 mL	6/15/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
ULTIVA FOR INJECTION 1 mg/vial	GlaxoSmithKline Manufacturing S.p.A.	SIN09542P	INJECTION, POWDER, FOR SOLUTION	1 mg/vial	11/21/1997

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
ULTIVA FOR INJ 1MG	N/A	Aspen Pharmacare Asia Limited	N/A	N/A	7/31/1998
ULTIVA FOR INJ 2MG	N/A	Aspen Pharmacare Asia Limited	N/A	N/A	7/31/1998

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
REMIFENTANIL VIATRIS 2mg remifentanil (as hydrochloride) powder for injection vial	163902	Alphapharm Pty Ltd	Medicine	A	10/15/2012
Remifentanil-AFT, remifentanil (as hydrochloride) 1 mg, powder for injection, glass vial	193697	AFT Pharmaceuticals Pty Ltd	Medicine	A	3/20/2013
ULTIVA Remifentanil (as hydrochloride) 5mg powder for injection vial	58690	Aspen Pharmacare Australia Pty Ltd	Medicine	A	5/4/1998
GenRx Remifentanil remifentanil (as hydrochloride) 5 mg powder for injection vial	234714	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/6/2016
ULTIVA Remifentanil (as hydrochloride) 2mg powder for injection vial	58689	Aspen Pharmacare Australia Pty Ltd	Medicine	A	5/11/1998
ULTIVA Remifentanil (as hydrochloride) 1mg powder for injection vial	58688	Aspen Pharmacare Australia Pty Ltd	Medicine	A	5/4/1998
REMIFENTANIL VIATRIS 5mg remifentanil (as hydrochloride) powder for injection vial	163903	Alphapharm Pty Ltd	Medicine	A	10/15/2012
Remifentanil-AFT, remifentanil (as hydrochloride) 2 mg, powder for injection, glass vial	194069	AFT Pharmaceuticals Pty Ltd	Medicine	A	3/20/2013
GenRx Remifentanil remifentanil (as hydrochloride) 1 mg powder for injection vial	234711	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/6/2016
GenRx Remifentanil remifentanil (as hydrochloride) 2 mg powder for injection vial	234713	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/6/2016

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
REMIFENTANILO ACCORD 2 mg POLVO PARA CONCENTRADO PARA SOLUCION INYECTABLE O PERFUSION EFG	Accord Healthcare S.L.U.	73420	POLVO PARA CONCENTRADO PARA SOLUCION INYECTABLE Y PARA PERFUSION	Uso Hospitalario. Estupefacientes	Not Commercialized
REMIFENTANILO ACCORD 1 mg POLVO PARA CONCENTRADO PARA SOLUCION INYECTABLE O PERFUSION EFG	Accord Healthcare S.L.U.	73419	POLVO PARA CONCENTRADO PARA SOLUCION INYECTABLE Y PARA PERFUSION	Uso Hospitalario. Estupefacientes	Not Commercialized
REMIFENTANILO ACCORD 5 mg POLVO PARA CONCENTRADO PARA SOLUCION INYECTABLE O PERFUSION EFG	Accord Healthcare S.L.U.	73421	POLVO PARA CONCENTRADO PARA SOLUCION INYECTABLE Y PARA PERFUSION	Uso Hospitalario. Estupefacientes	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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