Active substance
Ropivacaine
- SFDA 12
- US FDA 19
- Health Canada 6
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| BIOQ ROPIVACAINE 2MG/ML SOL. FOR INFUSION | 2 mg/ml | Solution for infusion · Intravenous use | 1 Bottle | SAR 639.75 | NCE · Prescription | BioQ Pharma Limited | Valid |
| NAROPIN 10MG-ML AMP | 10 mg/ml | Solution for injection · Inhalation use | 5 Ampoule | SAR 144.90 | NCE · Prescription | Aspen Pharma Trading Limited | Valid |
| NAROPIN 2MG-ML PLASTIC AMP | 2 mg/ml | Solution for injection · Inhalation use | 5 Ampoule | SAR 67.10 | NCE · Prescription | ASPEN PHARMA TRADING LIMITED (APTL) | Valid |
| NAROPIN 7.5MG-ML AMP | 7.5 mg/ml | Solution for injection · Inhalation use | 5 Ampoule | SAR 121.65 | NCE · Prescription | ASPEN PHARMA TRADING LIMITED (APTL) | Valid |
| Rivalast | 2 mg/ml | Solution for injection · Epilesional use | 10 Vial | SAR 93.95 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Rivalast | 7.5 mg/ml | Solution for injection · Epilesional use | 10 Vial | SAR 170.30 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Rivalast | 10 mg/ml | Solution for injection · Epilesional use | 10 Vial | SAR 202.85 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| NAROPIN 10MG-ML AMP | 10 mg/ml | Solution for injection · Inhalation use | 5 Ampoule | SAR 144.90 | NCE · Prescription | AstraZeneca | Withdrawn by MAH · Not Marketed |
| NAROPIN 10MG-ML AMP | 10 mg/ml | Solution for injection · Inhalation use | 5 Ampoule | SAR 94.20 | NCE · Prescription | AstraZeneca | Withdrawn by MAH · Not Marketed |
| NAROPIN 10MG-ML AMP | 10 mg/ml | Solution for injection · Inhalation use | 5 Ampoule | SAR 94.20 | NCE · Prescription | Aspen Pharma Trading Limited | Withdrawn by MAH · Not Marketed |
| NAROPIN 2MG-ML PLASTIC AMP | 2 mg/ml | Solution for injection · Inhalation use | 5 Ampoule | SAR 43.05 | NCE · Prescription | ASPEN PHARMA TRADING LIMITED (APTL) | Withdrawn by MAH · Not Marketed |
| NAROPIN 7.5MG-ML AMP | 7.5 mg/ml | Solution for injection · Inhalation use | 5 Ampoule | SAR 77.80 | NCE · Prescription | ASPEN PHARMA TRADING LIMITED (APTL) | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ANESTHESIA; SPASTICITY
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| NAROPIN | 20MG/10ML (2MG/ML); 40MG/20ML (2MG/ML); 100MG/20ML (5MG/ML); 150MG/20ML (7.5MG/ML); 100MG/10ML (10MG/ML); 200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML); 150MG/30ML (5MG/ML); 500MG/100ML (5MG/ML); 1GM/200ML (5MG/ML); 200MG/20ML (10MG/ML) | solution · injection | FRESENIUS KABI USA | Prescription | 24 Sep 1996 |
| ROPIVACAINE HYDROCHLORIDE | 5MG/ML(0.5%) | injectable · injection | NAVINTA LLC | Prescription | 17 Jul 2014 |
| ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML); 200MG/20ML (10MG/ML) | solution · injection | NAVINTA LLC | Prescription | 17 Jul 2014 |
| ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | solution · injection | RISING | Prescription | 11 Apr 2016 |
| ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML); 200MG/100ML (2MG/ML); 100MG/20ML (5MG/ML); 150MG/30ML (5MG/ML); 150MG/20ML (7.5MG/ML); 100MG/10ML (10MG/ML); 200MG/20ML (10MG/ML) | solution · injection | EUGIA PHARMA | Prescription | 13 Jul 2016 |
| ROPIVACAINE HYDROCHLORIDE | 200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML) | solution · injection | RISING | Prescription | 16 Mar 2018 |
| ROPIVACAINE HYDROCHLORIDE | 200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML); 500MG/100ML (5MG/ML); 1GM/200ML (5MG/ML) | solution · injection | INFORLIFE | Prescription | 11 Jun 2018 |
| ROPIVACAINE HYDROCHLORIDE | 20MG/10ML (2MG/ML); 40MG/20ML (2MG/ML); 100MG/20ML (5MG/ML); 150MG/30ML (5MG/ML); 150MG/20ML (7.5MG/ML); 100MG/10ML (10MG/ML); 200MG/20ML (10MG/ML) | solution · injection | SOMERSET THERAPS LLC | Prescription | 15 Jun 2018 |
| ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML); 100MG/20ML (5MG/ML); 150MG/30ML (5MG/ML); 200MG/20ML (10MG/ML); 200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML) | solution · injection | CAPLIN | Prescription | 9 Apr 2020 |
| ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML); 150MG/30ML (5MG/ML); 150MG/20ML (7.5MG/ML); 200MG/20ML (10MG/ML) | solution · injection | HIKMA PHARMS | Prescription | 20 Jul 2020 |
| ROPIVACAINE HYDROCHLORIDE | 200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML) | solution · injection | GLAND | Prescription | 18 Aug 2022 |
| ROPIVACAINE HYDROCHLORIDE | 200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML); 500MG/100ML (5MG/ML); 1GM/200ML (5MG/ML) | solution · injection | AMNEAL | Prescription | 8 Mar 2023 |
| ROPIVACAINE HYDROCHLORIDE | 200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML) | solution · injection | MYLAN LABS LTD | Prescription | 26 Oct 2023 |
| ROPIVACAINE HYDROCHLORIDE | 20MG/10ML (2MG/ML); 40MG/20ML (2MG/ML); 100MG/20ML (5MG/ML); 100MG/10ML (10MG/ML); 150MG/30ML (5MG/ML); 150MG/20ML (7.5MG/ML); 200MG/20ML (10MG/ML) | solution · injection | KINDOS | Prescription | 30 Jul 2024 |
| ROPIVACAINE HYDROCHLORIDE | 200MG/100ML (2MG/ML); 400MG/200ML (2MG/ML); 500MG/100ML (5MG/ML) | solution · injection | HIKMA | Prescription | 15 Aug 2024 |
| ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML); 150MG/30ML (5MG/ML); 200MG/20ML (10MG/ML); 20MG/10ML (2MG/ML); 100MG/20ML (5MG/ML) | solution · injection | ADAPTIS | Prescription | 21 Mar 2025 |
| NAROPIN | 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution · injection | FRESENIUS KABI USA | Discontinued | 24 Sep 1996 |
| ROPIVACAINE HYDROCHLORIDE | 20MG/10ML (2MG/ML); 150MG/30ML (5MG/ML); 150MG/20ML (7.5MG/ML); 100MG/10ML (10MG/ML); 40MG/20ML (2MG/ML); 200MG/20ML (10MG/ML) | solution · injection | HOSPIRA | Discontinued | 23 Sep 2014 |
| ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML); 150MG/30ML (5MG/ML); 150MG/20ML (7.5MG/ML); 200MG/20ML (10MG/ML) | solution · injection | RISING | Discontinued | 23 Sep 2014 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| NAROPIN | 02229411 | 2 MG / ML | SOLUTION · BLOCK/INFILTRATION; EPIDURAL | ASPEN PHARMACARE CANADA INC. |
| NAROPIN | 02229415 | 5 MG / ML | SOLUTION · BLOCK/INFILTRATION; EPIDURAL | ASPEN PHARMACARE CANADA INC. |
| NAROPIN | 02229418 | 10 MG / ML | SOLUTION · EPIDURAL | ASPEN PHARMACARE CANADA INC. |
| ROPIVACAINE HYDROCHLORIDE INJECTION, USP | 02439379 | 2 MG / ML | SOLUTION · INFILTRATION; EPIDURAL | FRESENIUS KABI CANADA LTD |
| ROPIVACAINE HYDROCHLORIDE INJECTION, USP | 02439387 | 5 MG / ML | SOLUTION · BLOCK/INFILTRATION; EPIDURAL | FRESENIUS KABI CANADA LTD |
| ROPIVACAINE HYDROCHLORIDE INJECTION, USP | 02439409 | 10 MG / ML | SOLUTION · EPIDURAL | FRESENIUS KABI CANADA LTD |
Safety signals and safety-related labeling changes
- US FDA 15 Jun 2022 NAROPIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; 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.