Active substance
Neostigmine methylsulfate
- SFDA 3
- US FDA 21
- Health Canada 6
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| EPISTIGMIN 2.5MG/ML VIAL | 2.5 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 7.75 | NCE · Prescription | EIPICO | Valid |
| NEOSTIGMINE METHYLSULFATE 0.5 MG/ML AMPOULE | 0.5 mg/ml | Solution for injection · Intramuscular use | 5 Ampoule | SAR 13.75 | Generic · Prescription | ALAMRIAH FOR PHARMACEUTICALS INDUSTRIES | Valid |
| NEOSTIGMINE 2.5MG-ML AMP | 2.5 mg/ml | Injection · Intravenous use | 10 Ampoule | SAR 14.75 | NCE · Prescription | ANTIGEN | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ANESTHESIA; MYASTHENIA GRAVIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML); 3MG/3ML (1MG/ML) | solution · intravenous | FRESENIUS KABI USA | Prescription | 8 Jan 2015 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML) | solution · intravenous | HIKMA PHARMS | Prescription | 28 Dec 2015 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML) | solution · intravenous | PH HEALTH | Prescription | 26 Apr 2017 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML) | solution · intravenous | AMPHASTAR PHARMS INC | Prescription | 25 Sep 2017 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML) | solution · intravenous | DR REDDYS | Prescription | 10 Jul 2018 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML) | solution · intravenous | J MOLNER | Prescription | 22 Aug 2018 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML) | solution · intravenous | BE PHARMS | Prescription | 13 May 2019 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML) | solution · intravenous | GLAND | Prescription | 16 Oct 2019 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML) | solution · intravenous | MEITHEAL | Prescription | 5 Apr 2021 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML) | solution · intravenous | CAPLIN | Prescription | 20 Apr 2021 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML) | solution · intravenous | REGCON HOLDINGS | Prescription | 1 Oct 2021 |
| NEOSTIGMINE METHYLSULFATE | 3MG/3ML (1MG/ML) | solution · intravenous | DR REDDYS | Prescription | 6 Jul 2022 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML) | solution · intravenous | NIVAGEN | Prescription | 3 Nov 2022 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML) | solution · intravenous | AVET LIFESCIENCES | Prescription | 25 Nov 2022 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML) | solution · intravenous | SAGENT PHARMS INC | Prescription | 17 Feb 2023 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML(0.5MG/ML); 10MG/10ML(1MG/ML) | injectable · injection | EUGIA PHARMA | Prescription | 2 Nov 2023 |
| BLOXIVERZ | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML); 5MG/5ML (1MG/ML) | solution · intravenous | EXELA PHARMA | Discontinued | 31 May 2013 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML) | solution · intravenous | AM REGENT | Discontinued | 4 May 2018 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML) | solution · intravenous | AMNEAL | Discontinued | 15 Jun 2018 |
| NEOSTIGMINE METHYLSULFATE | 3MG/3ML (1MG/ML) | solution · intravenous | HIKMA | Discontinued | 13 Jul 2022 |
| NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML); 10MG/10ML (1MG/ML) | solution · intravenous | EUGIA PHARMA | Discontinued | 2 Nov 2023 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| NEOSTIGMINE METHYLSULFATE INJECTION USP | 02475480 | 0.5 MG / ML | SOLUTION · INTRAVENOUS; INTRAMUSCULAR; SUBCUTANEOUS | MARCAN PHARMACEUTICALS INC |
| NEOSTIGMINE METHYLSULFATE INJECTION USP | 02475499 | 1 MG / ML | SOLUTION · SUBCUTANEOUS; INTRAMUSCULAR; INTRAVENOUS | MARCAN PHARMACEUTICALS INC |
| NEOSTIGMINE METHYLSULFATE INJECTION, USP | 02537516 | 0.5 MG / ML | SOLUTION · SUBCUTANEOUS; INTRAMUSCULAR; INTRAVENOUS | JAMP PHARMA CORPORATION |
| NEOSTIGMINE OMEGA | 02230592 | 1 MG / ML | LIQUID · INTRAMUSCULAR; SUBCUTANEOUS; INTRAVENOUS | OMEGA LABORATORIES LIMITED |
| NEOSTIGMINE OMEGA | 02230593 | 0.5 MG / ML | LIQUID · INTRAVENOUS; INTRAMUSCULAR; SUBCUTANEOUS | OMEGA LABORATORIES LIMITED |
| NEOSTIGMINE OMEGA | 02387166 | 2.5 MG / ML | SOLUTION · INTRAVENOUS; INTRAMUSCULAR; SUBCUTANEOUS | OMEGA LABORATORIES LIMITED |
Safety signals and safety-related labeling changes
- US FDA 19 Jan 2021 BLOXIVERZ — safety-related labeling change
Labeling sections changed: Use in Specific Populations
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.