MedPath

Racecadotril

Generic Name
Racecadotril
Drug Type
Small Molecule
Chemical Formula
C21H23NO4S
CAS Number
81110-73-8
Unique Ingredient Identifier
76K53XP4TO

Overview

Racecadotril has been investigated for the basic science and treatment of Diarrhea, Acute Diarrhea, and Acute Gastroenteritis.

Indication

主要用于腹泻,包括急性腹泻、与人免疫缺陷病毒(HIV)感染或获得性免疫缺陷综合征(艾滋病,AIDS)有关的慢性腹泻,也可与洛哌丁胺合用治疗依立替康所致腹泻。本品静注可用于阿片类物质的戒断症状。

Associated Conditions

  • Acute Diarrhea
  • Diarrhea

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/07/31
Phase 1
Not yet recruiting
2024/03/07
Phase 1
Not yet recruiting
Pharma Nueva
2022/10/31
Not Applicable
Recruiting
2022/02/01
Phase 1
Completed
2021/05/13
Not Applicable
UNKNOWN
2018/03/22
Phase 3
Completed
2018/03/13
Phase 3
Completed
2013/09/23
Phase 1
Completed
2012/04/13
Phase 4
Completed
Centro Pediatrico Albina de Patino
2011/11/22
Phase 1
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
Hidrasec Children Granules for Oral Suspension 30mg
SIN14413P
GRANULE, FOR SUSPENSION
30.00mg
9/30/2013
Hidrasec Infants Granules for Oral Suspension 10mg
SIN14412P
GRANULE, FOR SUSPENSION
10.00mg
9/30/2013

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
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
TIORFAN 100 mg CAPSULAS DURAS
Bioprojet Ferrer
63286
CÁPSULA DURA
Medicamento Sujeto A Prescripción Médica
Commercialized
TIORFAN INFANTIL 4 MG/ML SUSPENSIÓN ORAL
88685
SUSPENSIÓN ORAL
Medicamento Sujeto A Prescripción Médica
Not Commercialized
TIORFAN NIÑOS 30 mg GRANULADO PARA SUSPENSION ORAL
Bioprojet Ferrer
64809
GRANULADO PARA SUSPENSIÓN ORAL
Medicamento Sujeto A Prescripción Médica
Commercialized
TIORFAN NIÑOS 30 mg GRANULADO PARA SUSPENSION ORAL
5109186
GRANULADO PARA SUSPENSIÓN ORAL
Medicamento Sujeto A Prescripción Médica
Not Commercialized
TIORFAN 175 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
83529
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
HIDRASEC 100 MG CAPSULAS DURAS
Bioprojet Ferrer
77809
CÁPSULA DURA
Sin Receta
Commercialized
TIORFAN LACTANTES 10 mg GRANULADO PARA SUSPENSION ORAL
Bioprojet Ferrer
64816
GRANULADO PARA SUSPENSIÓN ORAL
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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