Solifenacin

Overview

Solifenacin is a competitive muscarinic receptor antagonist indicated to treat an overactive bladder with urinary incontinence, urgency, and frequency. It has a long duration of action as it is usually taken once daily. Solifenacin was granted FDA approval on 19 November 2004.

Indication

Solifenacin tablets are indicated to treat an overactive bladder with urinary incontinence, urgency, and frequency.

Associated Conditions

Benign Prostatic Hyperplasia (BPH)
Overactive Bladder Syndrome (OABS)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms	2025/01/31	NCT06803030	Phase 3	Not yet recruiting	Bir Hospital
Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)	2024/08/13	NCT06551246	Phase 3	Recruiting	University of Aarhus
Efficacy and Safety of VDS+SU in the Treatment of OAB-dry in Children	2024/07/08	NCT06489951	Not Applicable	Recruiting	Xing Liu
Efficacy of Solifenacin or Mirabegron With Local Estrogen Versus Combination Pharmacotherapy for Overactive Bladder	2024/06/28	NCT06479720	Phase 4	Recruiting	Mackay Memorial Hospital
Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)	2024/06/20	NCT06465576	Phase 4	Recruiting	University of Aarhus
Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children	2024/01/11	NCT06201013	Not Applicable	Recruiting	Xing Liu
Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity	2024/01/09	NCT06197295	Phase 4	Recruiting	Mackay Memorial Hospital
Comparison of the Transcutaneous Tibial Nerve Stimulation and Drug Treatment' Effects in Women With Overactive Bladder	2023/09/05	NCT06024005	Not Applicable	Completed	Ege University
IDB Injection Combined With PTNS for Managing Children With OAB Not Responding to Monotherapy	2023/06/22	NCT05911594	Not Applicable	Completed	Benha University
Efficacy of Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder	2023/04/04	NCT05798403	Not Applicable	Recruiting	Yin Ping

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
solifenacin succinate	Glenmark Pharmaceuticals Inc., USA	68462-386	ORAL	5 mg in 1 1	7/30/2020
Solifenacin	Zydus Lifesciences Limited	70771-1604	ORAL	5 mg in 1 1	10/17/2022
SOLIFENACIN SUCCINATE	Golden State Medical Supply, Inc.	51407-471	ORAL	5 mg in 1 1	8/3/2021
SOLIFENACIN SUCCINATE	Graviti Pharmaceuticals Private Limited	69844-048	ORAL	10 mg in 1 1	2/9/2022
Solifenacin Succinate	Novadoz Pharmaceuticals LLC	72205-020	ORAL	5 mg in 1 1	6/1/2020
Solifenacin Succinate	Alembic Pharmaceuticals Inc.	62332-193	ORAL	10 mg in 1 1	12/7/2021
Solifenacin Succinate	Bryant Ranch Prepack	71335-1729	ORAL	5 mg in 1 1	9/28/2020
solifenacin succinate	Glenmark Pharmaceuticals Inc., USA	68462-387	ORAL	10 mg in 1 1	7/30/2020
SOLIFENACINE SUCCINATE	Cipla USA Inc.	69097-259	ORAL	5 mg in 1 1	12/5/2022
Solifenacin Succinate	Bryant Ranch Prepack	63629-8869	ORAL	10 mg in 1 1	9/28/2020

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
SYNERRV SOLIFENACIN SUCCINATE FILM-COATED TABLETS 10MG	Umedica Laboratories Pvt. Ltd.	SIN16334P	TABLET, FILM COATED	10.00mg	9/27/2021
Vesicare Tablet 10mg	Astellas Pharma Europe B.V.	SIN13703P	TABLET, FILM COATED	10 mg	9/18/2009
BLADITON FILM COATED TABLETS 5MG	SUN PHARMACEUTICAL INDUSTRIES LIMITED	SIN15331P	TABLET, FILM COATED	5.00mg	9/14/2017
DALISOON F.C. TABLETS 5MG	Standard Chem. & Pharm. Co. Ltd.	SIN16679P	TABLET, FILM COATED	5 mg	1/18/2023
SOLICIN-5 FILM COATED TABLET 5 MG	Intas Pharmaceuticals Limited	SIN16510P	TABLET, FILM COATED	5 mg	6/9/2022
SYNERRV SOLIFENACIN SUCCINATE FILM-COATED TABLETS 5MG	UMEDICA LABORATORIES PVT LTD	SIN16335P	TABLET, FILM COATED	5.0mg	9/27/2021
Vesicare Tablet 5mg	Astellas Pharma Europe B.V	SIN13702P	TABLET, FILM COATED	5 mg	9/18/2009

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
BLADERIN TABLETS 5MG	N/A	Swiss Pharmaceutical (HK) Company Limited	N/A	N/A	10/30/2024
SOLICIN-5 TABLETS 5MG	N/A	Jacobson Marketing Limited	N/A	N/A	12/6/2017
SAPRAX TABLETS 10MG	N/A	Mediline (Hong Kong) Company Limited	N/A	N/A	2/29/2024
JUBSOLIFEN TABLETS 5MG	N/A	CONTROLLED MEDICATIONS LIMITED	N/A	N/A	5/10/2016
JUBSOLIFEN TABLETS 10MG	N/A	CONTROLLED MEDICATIONS LIMITED	N/A	N/A	5/10/2016

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
AKM SOLIFENACIN solifenacin succinate 10 mg tablet blister pack	288259	Pharmacor Pty Ltd	Medicine	A	4/10/2018
Seficare ODT solifenacin succinate 5 mg orodispersible tablets blister pack	316986	Accord Healthcare Pty Ltd	Medicine	A	9/17/2020
PHARMACOR SOLIFENACIN solifenacin succinate 5 mg tablet blister pack	288255	Pharmacor Pty Ltd	Medicine	A	4/10/2018
SOLIFENACIN GENPAR solifenacin succinate 10mg tablet blister pack	248403	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/19/2016
SOLIFENACIN CPL solifenacin succinate 10 mg tablet blister pack	288048	Cipla Australia Pty Ltd	Medicine	A	5/3/2018
SOLINACIN solifenacin succinate 5mg tablet blister pack	248410	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/19/2016
SOLIFENACIN INTAS solifenacin succinate 10 mg film-coated tablets blister pack	296749	Accord Healthcare Pty Ltd	Medicine	A	5/29/2019
SOLIFENACIN LUPIN solifenacin succinate 10 mg film-coated tablets blister pack	296748	Generic Health Pty Ltd	Medicine	A	5/29/2019
PHARMACOR SOLIFENACIN solifenacin succinate 10 mg tablet bottle pack	288258	Pharmacor Pty Ltd	Medicine	A	4/10/2018
SOLICIP solifenacin succinate 5 mg tablet blister pack	288053	Cipla Australia Pty Ltd	Medicine	A	5/3/2018

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MINT-SOLIFENACIN	mint pharmaceuticals inc	02443171	Tablet - Oral	5 MG	4/20/2016
SOLIFENACIN SUCCINATE TABLETS	Strides Pharma Canada Inc	02471019	Tablet - Oral	10 MG	N/A
SOLIFENACIN SUCCINATE TABLETS	Strides Pharma Canada Inc	02471000	Tablet - Oral	5 MG	N/A
PRZ-SOLIFENACIN	pharmaris canada inc	02493047	Tablet - Oral	10 MG	11/13/2020
ACT SOLIFENACIN	actavis pharma company	02422247	Tablet - Oral	10 MG	9/30/2015
PMS-SOLIFENACIN	Pharmascience Inc	02417723	Tablet - Oral	5 MG	10/28/2015
M-SOLIFENACIN SUCCINATE	mantra pharma inc	02529696	Tablet - Oral	5 MG	8/18/2023
APO-SOLIFENACIN	Apotex Inc	02423375	Tablet - Oral	5 MG	9/5/2018
MINT-SOLIFENACIN	mint pharmaceuticals inc	02443198	Tablet - Oral	10 MG	4/20/2016
DOM-SOLIFENACIN	dominion pharmacal	02459248	Tablet - Oral	10 MG	N/A

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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