Levocabastine

Overview

Levocabastine is a selective second-generation H1-receptor antagonist used for allergic conjunctivitis. Levocabastine was discovered at Janssen Pharmaceutica in 1979.

Indication

As an ophthalmic for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis. Also used as a nasal spray for allergic rhinitis.

Associated Conditions

Allergic Conjunctivitis (AC)
Allergic Rhinitis (AR)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study of Medication for Nonallergic Rhinitis (NAR) Based on Cluster Analysis	2019/06/28	NCT04002349	Not Applicable	UNKNOWN	Beijing Tongren Hospital
Clinical Trial to Evaluate the Efficacy and Safety of CKD-342	2015/07/15	NCT02498509	Phase 3	Completed	Chong Kun Dang Pharmaceutical
A Proof of Concept Study to Assess Effect of Fluticasone Furoate (FF)/Levocabastine Fixed Dose Combination (FDC) Compared With Levocabastine and FF Alone in Subjects With Allergic Rhinitis (AR)	2013/10/08	NCT01957202	Phase 2	Completed	GlaxoSmithKline
A Study to Assess Intranasal Repeat Dose Effect of Levocabastine in the Subjects With Allergic Rhinitis	2013/09/24	NCT01949051	Phase 2	Completed	GlaxoSmithKline

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
LIVOSTIN levocabastine hydrochloride 0.54 mg/mL nasal spray solution bottle	48290	Johnson & Johnson Pacific Pty Ltd	Medicine	A	5/6/1994
ZYRTEC Eye Drops levocabastine hydrochloride 0.54 mg/mL eye drops bottle	227289	Johnson & Johnson Pacific Pty Ltd	Medicine	A	8/27/2014
LIVOSTIN EYE DROPS levocabastine hydrochloride 0.54 mg/mL eye drops suspension bottle	48289	Johnson & Johnson Pacific Pty Ltd	Medicine	A	5/6/1994
ZYRTEC levocabastine hydrochloride 0.54 mg/mL nasal spray bottle	227290	Johnson & Johnson Pacific Pty Ltd	Medicine	A	8/27/2014

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
REACTINE LEVOCABASTINA 0,5mg/ml COLIRIO EN SUSPENSION	Jntl Consumer Health (Spain) S.L.	60920	COLIRIO EN SUSPENSIÓN	Sin Receta	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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