Overview
Metamizole (dipyrone) is a pyrazolone derivative that belongs to the group of nonacid nonopioids. It is considered a potent analgesic and antipyretic with favourable gastrointestinal tolerability. Metamizole was formerly marketed in the US as Dimethone tablets and injection, Protemp oral liquid, and other drug products, and was withdrawn due to its association with potentially fatal agranulocytosis. Approvals of the NDA's for metamizole drug products were withdrawn on June 27, 1977 (see the Federal Register of June 17, 1977, 42 FR 30893). In 1963, metamizole was withdrawn from the Canadian market and banned in the UK, France, Sweden, Norway and Australia. Metamizole is still used in certain countries in Europe, Asia and South America.
Indication
Metamizole is banned in several countries, where it was previously used as a powerful analgesic and fever reducer. In countries where it is still available, metamizole is indicated for acute severe pain after injuries or surgeries, colic, tumor pain, and acute or severe pain symptoms, as well as high fever if other treatments are unsuccessful.
Associated Conditions
- Severe Pain
- Severe Fever
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2017/08/09 | Phase 4 | Completed | |||
2017/06/29 | Phase 3 | UNKNOWN | Hospital General Universitario Elche | ||
2016/11/25 | Not Applicable | Completed | |||
2016/11/23 | Not Applicable | Completed | |||
2016/06/29 | Not Applicable | Completed | Universidade Estadual Paulista Júlio de Mesquita Filho | ||
2016/06/27 | Not Applicable | Completed | Universidade Estadual Paulista Júlio de Mesquita Filho | ||
2016/06/17 | Phase 4 | Completed | Michał Borys | ||
2016/03/17 | Phase 3 | Terminated | |||
2016/02/23 | Phase 4 | Terminated | |||
2016/02/19 | Phase 4 | Completed | University Hospital, Basel, Switzerland |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Metamizole Sodium Tablets | 国药准字H52020676 | 化学药品 | 片剂 | 11/15/2019 | |
| Metamizole Sodium Tablets | 国药准字H52020311 | 化学药品 | 片剂 | 8/19/2020 | |
| Metamizole Sodium Tablets | 国药准字H34020667 | 化学药品 | 片剂 | 4/22/2020 | |
| Metamizole Sodium Tablets | 国药准字H41021036 | 化学药品 | 片剂 | 11/13/2019 | |
| Metamizole Sodium Tablets | 国药准字H41021607 | 化学药品 | 片剂 | 6/9/2020 | |
| Metamizole Sodium Tablets | 国药准字H22021384 | 化学药品 | 片剂 | 4/8/2020 | |
| Metamizole Sodium Tablets | 国药准字H41020008 | 化学药品 | 片剂 | 6/24/2020 | |
| Metamizole Sodium Tablets | 国药准字H34022820 | 化学药品 | 片剂 | 4/17/2020 | |
| Metamizole Sodium Tablets | 国药准字H41020200 | 化学药品 | 片剂 | 3/4/2020 | |
| Metamizole Sodium Tablets | 国药准字H14021557 | 化学药品 | 片剂 | 7/30/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
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