Pinaverium

Overview

Pinaverium is a spasmolytic agent used for functional gastrointestinal disorders. It is a quaternary ammonium compound that acts as an atypical calcium antagonist to restore normal bowel function. It is shown to relieve GI spasm and pain, transit disturbances and other symptoms related to motility disorders and may be considered as effective first-lline therapy for patients with irritable bowel syndrome (IBS) . Pinaverium bromide is the common ingredient in formulations, mostly as oral tablets. Although it is not a currently approved drug by the FDA, pinaverium is available in over 60 countries including Canada.

Indication

Pinaverium is indicated for the symptomatic treatment of irritable bowel syndrome (IBS) and functional disorders of the biliary tract.

Associated Conditions

Flatulence
Irritable Bowel Syndrome (IBS)
Functional disorders of the biliary tract
Stomach cramps

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Pinaverium Bromide Preventing Post Extracorporeal Shock Wave Lithotripsy Pancreatitis and Painful (PBPEP)	2025/04/20	NCT06936800	Not Applicable	ENROLLING_BY_INVITATION	Yanqing Li
Pinaverium Bromide in Post-cholecystectomy Sphincter of Oddi Dysfunction	2016/07/14	NCT02833103	Phase 4	UNKNOWN	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Pinaverium and Herbs for Irritable Bowel Syndrome Treatment: an Onset and Offset Study (PHIBEST)	2015/01/01	NCT02330029	Not Applicable	UNKNOWN	Macrohard Institute of Health
Pinverin Application Trial to Reduce Bowel Uptake of FDG (Fluorodeoxyglucose)	2014/06/25	NCT02173964	Phase 4	Completed	Seoul National University Hospital
A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome	2012/07/16	NCT01641224	Not Applicable	UNKNOWN	University of Minnesota

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PINAVERIUM	aa pharma inc	02469677	Tablet - Oral	50 MG	9/13/2018
DICETEL	BGP Pharma ULC	02230684	Tablet - Oral	100 MG	7/5/1999
DICETEL	BGP Pharma ULC	01950592	Tablet - Oral	50 MG	12/31/1993
PINAVERIUM	aa pharma inc	02469685	Tablet - Oral	100 MG	9/13/2018

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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