Overview
Roxithromycin is a semi-synthethic macrolide antibiotic that is structurally and pharmacologically similar to erythromycin, azithromycin, or clarithromycin. It was shown to be more effective against certain Gram-negative bacteria, particularly Legionella pneumophila. Roxithromycin exerts its antibacterial action by binding to the bacterial ribosome and interfering with bacterial protein synthesis. It is marketed in Australia as a treatment for respiratory tract, urinary and soft tissue infections.
Indication
Used to treat respiratory tract, urinary and soft tissue infections.
Associated Conditions
- Lower Respiratory Tract and Lung Infections
- Respiratory Tract Infections (RTI)
- Skin Infections
- Ear, nose, and throat infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/10/10 | Phase 3 | Completed | |||
2016/06/30 | Phase 4 | UNKNOWN | |||
2007/02/22 | Phase 4 | Completed | Nazilli State Hospital | ||
2005/09/20 | Not Applicable | UNKNOWN | Hamamatsu University |
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 |
|---|---|---|---|---|---|
| UPLORES CAPSULE 150 mg | SIN11413P | CAPSULE | 150 mg | 10/20/2000 |
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 |
|---|---|---|---|---|---|
| ROXICIN TAB 150MG | N/A | N/A | N/A | 10/27/2000 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ROXITHROMYCIN-WGR roxithromycin 150 mg tablet blister pack | 333546 | Medicine | A | 5/4/2020 | |
| ROXIMYCIN roxithromycin 300mg tablet blister pack | 99939 | Medicine | A | 3/30/2004 | |
| GENRX ROXITHROMYCIN roxithromycin 300 mg film coated tablets blister pack | 133747 | Medicine | A | 4/10/2008 | |
| PHARMACOR ROXITHROMYCIN roxithromycin 300 mg film coated tablets blister pack | 133759 | Medicine | A | 4/10/2008 | |
| APX-ROXITHROMYCIN roxithromycin 300 mg tablet blister pack | 333543 | Medicine | A | 5/4/2020 | |
| PHARMACOR ROXITHROMYCIN roxithromycin 150 mg film coated tablets blister pack | 133758 | Medicine | A | 4/10/2008 | |
| ROXIMYCIN roxithromycin 150mg tablet blister pack | 99937 | Medicine | A | 3/30/2004 | |
| ROXITHROMYCIN SCP roxithromycin 150 mg film coated tablets blister pack | 133756 | Medicine | A | 4/10/2008 | |
| ROXITHROMYCIN-WGR roxithromycin 300 mg tablet blister pack | 333545 | Medicine | A | 5/4/2020 | |
| GENRX ROXITHROMYCIN roxithromycin 150 mg film coated tablets blister pack | 133746 | Medicine | A | 4/10/2008 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| RULIDE 300 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Sanofi Aventis S.A. | 61363 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ROXITROMICINA SANDOZ 150 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Sandoz Farmaceutica S.A. | 64803 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ROXITROMICINA SANDOZ 300 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Sandoz Farmaceutica S.A. | 64815 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
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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