Overview
Bilastine is a novel new-generation antihistamine that is highly selective for the H1 histamine receptor, has a rapid onset and prolonged duration of action.
Indication
For symptomatic relief of nasal and non-nasal symptoms of seasonal rhinitis in patients 12 years of age and older and for symptomatic relief in chronic spontaneous urticaria in patients 18 years of age and older .
Associated Conditions
- Chronic Spontaneous Urticaria
- Seasonal Allergic Rhinitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/10/24 | Phase 1 | Not yet recruiting | |||
2021/03/23 | Phase 3 | Completed | |||
2018/08/16 | Phase 1 | UNKNOWN | |||
2018/03/27 | Phase 3 | Completed | |||
2017/07/27 | Phase 2 | Completed | |||
2016/05/04 | Phase 4 | Completed | |||
2015/10/15 | Phase 4 | Completed | |||
2015/09/23 | Phase 4 | UNKNOWN | Association Asthma, Bulgaria | ||
2015/07/31 | Phase 4 | Completed | Universidade do Sul de Santa Catarina | ||
2014/08/11 | Phase 3 | Completed |
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 |
|---|---|---|---|---|---|
| ALIGRIN TABLET 20MG | SIN16474P | TABLET | 20MG | 4/12/2022 | |
| BILAXTEN TABLET 20 mg | SIN14661P | TABLET | 20.00 mg | 11/11/2014 | |
| BILAXTEN ORODISPERSIBLE TABLET 10MG | SIN15874P | TABLET, ORALLY DISINTEGRATING | 10MG/TABLET | 1/13/2020 | |
| BILAXTEN ORAL SOLUTION 2.5MG/ML | SIN15963P | SOLUTION | 2.5MG/ML | 6/24/2020 | |
| BILAXTEN TABLET 20 MG (PHARMACY ONLY) | SIN17104P | TABLET | 20.00 mg | 10/2/2024 |
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 |
|---|---|---|---|---|---|
| BILAZIN 20 TABLETS 20MG | N/A | N/A | N/A | 12/9/2024 | |
| VILARIN TABLETS 20MG | N/A | N/A | N/A | 5/26/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ALLERTINE bilastine 20 mg tablet blister pack | 387574 | A Menarini Australia Pty Ltd | Medicine | A | 4/27/2022 |
| ALLERTINE MELTLETS bilastine 20 mg orally disintegrating tablet blister pack | 480827 | A Menarini Australia Pty Ltd | Medicine | A | 2/26/2025 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| BLEXTEN | aralez pharmaceuticals canada inc | 02454130 | Tablet - Oral | 20 MG | 12/2/2016 |
| JAMP BILASTINE | 02546795 | Tablet - Oral | 20 MG | 10/22/2024 | |
| APO-BILASTINE ORODISPERSIBLE TABLETS | 02549875 | Tablet (Orally Disintegrating) - Oral | 10 MG | N/A | |
| M-BILASTINE | mantra pharma inc | 02548410 | Tablet - Oral | 20 MG | 10/24/2024 |
| BLEXTEN | aralez pharmaceuticals canada inc | 02519038 | Tablet (Orally Disintegrating) - Oral | 10 MG | 2/10/2022 |
| JAMP BILASTINE ORAL SOLUTION | 02448262 | Solution - Oral | 2.5 MG / ML | N/A | |
| NRA-BILASTINE | nora pharma inc | 02551934 | Tablet - Oral | 20 MG | 10/30/2024 |
| BLEXTEN | aralez pharmaceuticals canada inc | 02519011 | Solution - Oral | 2.5 MG / ML | 2/10/2022 |
| APO-BILASTINE ORAL SOLUTION | 02549867 | Solution - Oral | 2.5 MG / ML | N/A | |
| APO-BILASTINE TABLETS | 02549883 | Tablet - Oral | 20 MG | 10/29/2024 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| IBIS 10 MG COMPRIMIDOS BUCODISPERSABLES | 82661 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| BILAXTEN 20 MG COMPRIMIDOS | 34009_499_140_1_2_IP1 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| BILASTINA TEVA 10 MG COMPRIMIDOS BUCODISPERSABLES EFG | 88342 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| OBALIX 2,5 MG/ML SOLUCION ORAL | 82663 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| BILASTINA FLAS COMBIX 10 MG COMPRIMIDOS BUCODISPERSABLES EFG | Laboratorios Combix S.L.U. | 90211 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ABRILIA 20 MG COMPRIMIDOS EFG | Laboratorios Normon S.A. | 85180 | COMPRIMIDO | Sin Receta | Commercialized |
| BILASTINA TEVA 20 MG COMPRIMIDOS BUCODISPERSABLES EFG | 88343 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| OBALIX 20 mg COMPRIMIDOS | 73028 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| IBIS 20 MG COMPRIMIDOS BUCODISPERSABLES | 88728 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| BILAXTEN 20 mg COMPRIMIDOS | Laboratorios Vitoria, S.A. | 5341508 | COMPRIMIDO | 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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