MedPath

Pefloxacin

Generic Name
Pefloxacin
Drug Type
Small Molecule
Chemical Formula
C17H20FN3O3
CAS Number
70458-92-3
Unique Ingredient Identifier
2H52Z9F2Q5

Overview

A synthetic broad-spectrum fluoroquinolone antibacterial agent active against most gram-negative and gram-positive bacteria.

Background

A synthetic broad-spectrum fluoroquinolone antibacterial agent active against most gram-negative and gram-positive bacteria.

Indication

For the treatment of uncomplicated gonococcal urethritis in males and for gram-negative-bacterial infections in the gastrointestinal system and the genitourinary tract.

Associated Conditions

  • Susceptible Bacterial Infections

Clinical Trials

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Posted
Study ID
Phase
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Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Approved Products

Product Name
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Route
Strength
Approved
NDC Code

No FDA products found

No FDA products found for this drug

EMA Approved Products

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EMA Number
Auth. Holder
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Drug Type
Status
Issued
Opinion
Revision

No EMA products found

No EMA products found for this drug

HSA Approved Products

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Manufacturer
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Strength
Approved
Approval No.

No HSA products found

No HSA products found for this drug

NMPA Approved Products

Product Name
Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import
国药准字H20010474
注射剂(注射液)
典沙
100ml:甲磺酸培氟沙星0.4g(以培氟沙星计)与葡萄糖5g
Chemical Drug
Approved
2020/06/17
Domestic
国药准字H20040710
N/A
N/A
250ml:培氟沙星0.4g与葡萄糖12.5g
Chemical Drug
Approved
2004/05/20
Domestic
国药准字H20050289
注射剂(注射液)
典沙
100ml:甲磺酸培氟沙星0.2g(以培氟沙星计)与葡萄糖5g
Chemical Drug
Approved
2015/09/16
Domestic
国药准字H20010148
注射剂
N/A
100ml:培氟沙星0.2g与葡萄糖5g
Chemical Drug
Approved
2024/07/30
Domestic
国药准字H20031080
注射剂
N/A
200ml:培氟沙星0.4g与葡萄糖10g
Chemical Drug
Approved
2024/07/30
Domestic
国药准字H20030109
注射剂
N/A
100ml:培氟沙星0.4g与葡萄糖5g
Chemical Drug
Approved
2024/07/30
Domestic
国药准字H20103309
注射剂
N/A
5ml:0.4g(按C17H20FN303计算)
Chemical Drug
Approved
2015/06/26
Domestic
国药准字H20058009
N/A
N/A
2ml:0.2g(以培氟沙星计)
Chemical Drug
Approved
2005/09/29
Domestic
国药准字H20063931
注射剂
N/A
5ml:0.4g(以培氟沙星计)
Chemical Drug
Approved
2020/08/13
Domestic
国药准字H20057971
注射剂
N/A
2ml:0.2g(以培氟沙星计)
Chemical Drug
Approved
2015/05/22
Domestic

PPB Approved Products

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Registration Code
Company
Category
Sale Type
Reg. Date

No PPB products found

No PPB products found for this drug

TGA Approved Products

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ARTG ID
Sponsor
Status
Reg. Date
Ingredient

No TGA products found

No TGA products found for this drug

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