Ropivacaine

Overview

Ropivacaine is an aminoamide local anesthetic drug marketed by AstraZeneca under the trade name Naropin. It exists as a racemate of its S- and R-enantiomers, although the marketed form is supplied only as the purified S-enantiomer.

Indication

Ropivacaine is indicated in adult patients for the induction of regional or local anesthesia for surgery or acute pain management.

Associated Conditions

Acute Pain
Postoperative pain

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Intrapleural Ropivacaine Infusion in Cardiac Surgery	2025/08/11	NCT07116343	Not Applicable	Not yet recruiting	Saint Petersburg State University, Russia
Comparative Experimental Study Between Bupivacaine and Ropivacaine Regarding Efficacy in Third Molar Removal Surgery Under General Anesthesia	2025/08/07	NCT07108465	Not Applicable	Recruiting	Henrique Tedesco
Rectus Sheath Catheters Following Midline Laparotomy	2025/08/01	NCT07099924	Not Applicable	Not yet recruiting	Asklepios Kliniken Hamburg GmbH
R.E.C.K vs Exparel in Robotic Nephrectomy	2025/07/30	NCT07092566	Not Applicable	Not yet recruiting	Wake Forest University Health Sciences
Efficacy of Cervical Sympathetic Blocks for PTSD	2025/07/25	NCT07087015	Not Applicable	Not yet recruiting	Stanford University
EIT Evaluation of Pulmonary Ventilation With Different Ropivacaine Concentrations in Intercostal Nerve Blockade	2025/07/23	NCT07079436	Not Applicable	Not yet recruiting	Fudan University
Ropivacaine and Fentanyl for Labor Epidural Initiation	2025/07/22	NCT07076368	Not Applicable	Not yet recruiting	University of California, San Francisco
PENG Block Optimization: Volume and Dexamethasone Effects	2025/06/15	NCT07023120	Phase 4	Recruiting	Poznan University of Medical Sciences
NLR and PLR Levels Following iPACK Block in Hip Arthroplasty	2025/06/15	NCT07023107	Phase 4	Recruiting	Poznan University of Medical Sciences
Addition of Dexmedetomidine to Ropivacaine in Bilateral Erector Spinae Plane Block in Patients Undergoing Coronary Artery Bypass Surgery	2025/05/21	NCT06981949	Phase 4	Not yet recruiting	Lebanese American University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ROPIVACAINE HYDROCHLORIDE	Baxter Healthcare Corporation	43066-015	EPIDURAL, INFILTRATION, PERINEURAL	2 mg in 1 mL	4/9/2020
Ropivacaine Hydrochloride	Caplin Steriles Limited	65145-108	EPIDURAL, INFILTRATION, PERINEURAL	5 mg in 1 mL	1/4/2024
Ropivacaine hydrochloride	Gland Pharma Limited	68083-263	INFILTRATION, EPIDURAL	2 mg in 1 mL	8/22/2022
ROPIVACAINE HYDROCHLORIDE	Baxter Healthcare Corporation	43066-027	EPIDURAL, INFILTRATION, PERINEURAL	10 mg in 1 mL	4/9/2020
Ropivacaine Hydrochloride	Hikma Pharmaceuticals USA Inc.	0143-9264	EPIDURAL, INFILTRATION	5 mg in 1 mL	3/23/2023
Ropivacaine Hydrochloride	Hospira, Inc.	0409-9300	INFILTRATION, EPIDURAL, PERINEURAL	2 mg in 1 mL	3/4/2024
Ropivacaine Hydrochloride	Amneal Pharmaceuticals LLC	70121-1733	EPIDURAL, INFILTRATION, PERINEURAL	2 mg in 1 mL	10/19/2023
Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	70069-067	EPIDURAL	10 mg in 1 mL	7/12/2022
Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	70069-064	EPIDURAL, INFILTRATION, PERINEURAL	5 mg in 1 mL	7/12/2022
Ropivacaine Hydrochloride	NorthStar Rx LLC	72603-219	EPIDURAL	10 mg in 1 mL	3/1/2024

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
ROPIVACAINE-AFT SOLUTION FOR INJECTION 1% W/V	Elpen Pharmaceutical Co., Inc	SIN15261P	INJECTION, SOLUTION	10 mg/mL	6/8/2017
ROPIVACAINE-AFT SOLUTION FOR INFUSION 0.2% W/V	Elpen Pharmaceutical Co., Inc	SIN15264P	INFUSION, SOLUTION	2.0 mg/mL	6/8/2017
NAROPIN INFUSION 0.2%	ASTRAZENECA PTY LTD	SIN09262P	INJECTION	2 mg/ml	3/26/1997
ROPIVACAINE-AFT SOLUTION FOR INJECTION 0.2% W/V	Elpen Pharmaceutical Co., Inc	SIN15263P	INJECTION, SOLUTION	2.0 mg/mL	6/8/2017
ROPIVACAINE-AFT SOLUTION FOR INJECTION 0.75% W/V	Elpen Pharmaceutical Co., Inc	SIN15262P	INJECTION, SOLUTION	7.5 mg/mL	6/8/2017
NAROPIN INJECTION 1%	ASTRAZENECA AB	SIN09264P	INJECTION	10 mg/ml	3/26/1997
ROPIVACAINE B.BRAUN SOLUTION FOR INJECTION AND INFUSION 2MG/ML	B. Braun Medical S.A.	SIN17164P	INJECTION, SOLUTION	2mg/ml	1/16/2025

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
NAROPIN 0.5% ropivacaine hydrochloride 50mg/10mL injection ampoule	52402	Aspen Pharmacare Australia Pty Ltd	Medicine	A	1/30/1996
NAROPIN 1% ropivacaine hydrochloride 100mg/10mL injection ampoule	52398	Aspen Pharmacare Australia Pty Ltd	Medicine	A	1/30/1996
NAROPIN 0.2% WITH FENTANYL 800 microgram/200mL	72875	Aspen Pharmacare Australia Pty Ltd	Medicine	A	5/23/2000
ROPIBAM 0.75% Ropivacaine hydrochloride 75mg/10mL solution for injection ampoule	186572	Boucher & Muir Pty Ltd	Medicine	A	3/9/2012
ROPIVACAINE KABI ropivacaine hydrochloride 150 mg/20 mL solution for injection ampoule	195807	Fresenius Kabi Australia Pty Ltd	Medicine	A	6/13/2013
ROPIVACAINE KABI ropivacaine hydrochloride 100 mg/10 mL solution for injection ampoule	195808	Fresenius Kabi Australia Pty Ltd	Medicine	A	6/13/2013
NAROPIN 0.2% WITH FENTANYL 200 microgram/100mL	72874	Aspen Pharmacare Australia Pty Ltd	Medicine	A	5/23/2000
ROPIVACAINE KABI ropivacaine hydrochloride 400 mg/200 mL solution for infusion bag	195811	Fresenius Kabi Australia Pty Ltd	Medicine	A	6/13/2013
ROPIVACAINE KABI ropivacaine hydrochloride 200 mg/20 mL solution for injection ampoule	195809	Fresenius Kabi Australia Pty Ltd	Medicine	A	6/13/2013
Ropivacaine-AFT 0.2% ropivacaine hydrochloride 200 mg/100 mL solution for infusion bag	310404	AFT Pharmaceuticals Pty Ltd	Medicine	A	12/20/2019

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
XFUSOR	formative pharma inc.	02556472	Solution - Block/Infiltration	2 MG / ML	N/A
NAROPIN	Aspen Pharmacare Canada Inc.	02229418	Solution - Epidural	10 MG / ML	4/14/1997
ROPIVACAINE HYDROCHLORIDE INJECTION, USP	fresenius kabi canada ltd	02439379	Solution - Epidural , Infiltration	2 MG / ML	9/28/2018
ROPIVACAINE HYDROCHLORIDE INJECTION, USP	fresenius kabi canada ltd	02439387	Solution - Epidural , Block/Infiltration	5 MG / ML	9/13/2019
NAROPIN	Aspen Pharmacare Canada Inc.	02229411	Solution - Block/Infiltration , Epidural	2 MG / ML	4/14/1997
ROPIVACAINE HYDROCHLORIDE INJECTION USP	Pfizer Canada Ulc	02347822	Solution - Block/Infiltration , Epidural	5 MG / ML	12/14/2010
ROPIVACAINE HYDROCHLORIDE INJECTION USP	Pfizer Canada Ulc	02403285	Solution - Epidural , Block/Infiltration	2 MG / ML	N/A
NAROPIN	Aspen Pharmacare Canada Inc.	02229415	Solution - Block/Infiltration , Epidural	5 MG / ML	4/14/1997
ROPIVACAINE HYDROCHLORIDE INJECTION	teva canada limited	02408589	Solution - Block/Infiltration , Epidural	2 MG / ML	N/A
ROPIVACAINE HYDROCHLORIDE INJECTION, USP	fresenius kabi canada ltd	02439409	Solution - Epidural	10 MG / ML	2/26/2019

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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