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Country of origin : Netherlands

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2 products found

solifenacin + tamsulosin

Tablets, modified release (MR) 6 mg + 0.4 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Comments
DCP approved
Manufacturer #276
This company is a global manufacturer and distributor of high-quality generic medicines, with a mission to make these medicines accessible to patients worldwide. It operates in several regions, including Europe and Latin America, and emphasizes strong partnerships within the pharmaceutical industry to expand its reach. The company is committed to sustainability and transparency, following Environmental, Social, and Governance (ESG) principles. They regularly engage in major industry events, highlighting their dedication to networking and maintaining a leading position in the market for generic medications.

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SOLIFENACIN

Solifenacin is an antimuscarinic medication. It treats overactive bladder, a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination. Solifenacin is also used to treat neurogenic detrusor overactivity, a condition in which a bladder control condition caused by a brain, spinal cord or nerve problem in children 2 years of age and older. Solifenacin is called an antimuscarinic, they work by relaxing the bladder muscles.
Solifenacin is sold under the brand name Vesicare among others. Yamanouchi Pharma America, Inc studied the compound using animal models in the early 2000s. Solifenacin was first approved for sale in the United States in 2004 with an indication to treat overactive bladder in adults older than 18 years. In May 2020, FDA to treat neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children ages two years and older, approved Solifenacin.

Forms and dosage:

The Usual Adult Dose recommended for treating Urinary Incontinence is an initial dose of 5 mg, orally, once daily. This is followed by a maintenance dose of 5 to 10 mg, taken orally, once a day. For treating overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency, the usual adult dose starts with 5 mg, followed by a maintenance dose of 5 to 10 mg, taken orally, once daily.

The cost of Solifenacin

As of 2019, consumers in the United Kingdom paid about £27.62 for a month's supply. However, this is significantly higher in the United States, with the cost of the same supply is about US$370.

How does it work?

Its action improves the ability of the patient to control urination by relaxing the muscles in the bladder. It also reduces leaking of urine, urges to urinate urgently and reduces the frequency of trips to the washroom. To elaborate, it works as a competitive cholinergic receptor antagonist, selective for the M3 receptor subtype. When acetylcholine binds to these receptors, particularly M3, it makes contraction of smooth muscle possible. This medicine prevents the binding of acetylcholine to these receptors, thus reducing the smooth muscle tone in the bladder. The overall effects of the activity increase the bladder’s ability to retain larger volumes of urine and reducing the number of micturition, urgency and incontinence episodes.

Finding Solifenacin Manufacturers and Suppliers:

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