Overview
Bromelain is a protease enzyme derived from the stems of pineapples that is composed of a mixture of different thiol endopeptidases and other components like phosphatase, glucosidase, peroxidase, cellulase, escharase, and several protease inhibitors . It works by selectively inhibiting the biosynthesis of proinflammatory prostaglandins and also has analgesic properties, as well as anticancerous and pro-apoptotic effects. Bromelain holds potential therapeutic effect as a treatment of conditions including angina pectoris, bronchitis, sinusitis, surgical trauma, and osteoarthritis. It is considered as a safe food supplement.
Indication
可用于各种原因所致的炎症、水肿、血肿、血栓症如支气管炎、支气管哮喘、急性肺炎、产后乳房充血、乳腺炎、产后血栓性静脉炎、视网膜炎等，与抗菌药物合用治疗关节炎、关节周围炎、蜂窝织炎、小腿溃疡等均有效。眼科用于治疗视网膜炎。
Associated Conditions
- Swelling
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/17 | Phase 1 | Recruiting | Krishnadevaraya College of Dental Sciences & Hospital | ||
2022/02/28 | Phase 1 | UNKNOWN | |||
2020/08/13 | Phase 2 | Completed | |||
2019/06/06 | Phase 2 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| Ultra Inflamase | 351743 | Medicine | A | 12/15/2020 | |
| Gut Calm + Restore | 444372 | Medicine | A | 3/25/2024 | |
| Plexus ProBioFit | 353839 | Medicine | A | 1/29/2021 | |
| ProBioFit | 483565 | Medicine | A | 3/21/2025 | |
| Eagle Clinical Tresos B Professional + | 489429 | Medicine | A | 5/21/2025 | |
| Eagle Vegie Digestaid | 330721 | Medicine | A | 3/4/2020 | |
| Lymphodran Plus | 302620 | Medicine | A | 5/4/2018 | |
| Bioglan Platinum Digest Eze | 423692 | Medicine | A | 10/3/2023 | |
| Inner Essentials Skin + Gut Renew | 375454 | Medicine | A | 9/29/2021 | |
| BioFlam | 217896 | Medicine | A | 11/29/2013 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ACTIVATED ENZYME CONCENTRATE | malabar formulas | 00603929 | Tablet - Oral | 64 MG | 12/31/1983 |
| BROMELAIN 500 (300GDU/CAPSULE) | quest vitamins a div of purity life health products | 02034735 | Capsule - Oral | 500 MG | 12/31/1993 |
| BROMANASE 1800 TAB 225MG | nf formulas inc. | 00621692 | Tablet - Oral | 225 MG | 12/31/1984 |
| BROMELAIN-PAPAIN | seroyal international inc. | 00565504 | Tablet - Oral | 80 MG | 12/31/1981 |
| BROMELAIN 250 | thorne research inc. | 00634670 | Capsule - Oral | 250 MG | 12/31/1984 |
| VITAMIN E TAB 500 | trophic canada ltd. | 00141194 | Tablet - Oral | 10 MG | 12/31/1971 |
| THERAPY FORMULAS MULTI-ENZYME FORMULA-CAP | general nutrition canada inc. | 02216736 | Capsule - Oral | 50 MG | 10/15/2001 |
| GNC NATURAL BRAND TM BROMELAIN 100000GDU | general nutrition canada inc. | 02181320 | Tablet - Oral | 50 MG | 10/20/2002 |
| FLORADIX MULTIZYME HERBAL TAB | salus-haus | 00307661 | Tablet - Oral | 8 MG | 12/31/1974 |
| BROMELAIN AND PAPAIN TAB | vita health products inc | 00430447 | Tablet - Oral | 75 MG | 12/31/1978 |
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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