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CMDh RECOMMENDATIONS AZITHROMYCIN CONTAINING MEDICINAL PRODUCTS Severe Hepatic Impairment contraindication SmPC and PL wording agreed by the CMDh in October 2010 Doc.Ref.: CMDh[removed]October 2010
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Document Date: 2010-11-17 10:34:57

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Company

To / /

Country

Egypt / France / Japan / Korea / China / Cyprus / Greece / /

Event

Product Issues / /

IndustryTerm

generic product / administration site / hepatotoxic medicinal products / medicinal products / /

MedicalCondition

Hepatic fibrosis / Hepatitis A / General disorders / respiratory failure / liver dysfunction / liver failure / case hepatobiliary disorders / Cirrhosis / pre-existing hepatic disease / hepatic encephalopathy / Hepatitis C / Hepatitis B / significant hepatic disease / B liver cirrhosis / fulminant hepatitis / Hepatic failure / ventricular fibrillation / Chronic hepatitis / Hepatic cirrhosis / /

MedicalTreatment

renal dialysis / /

Organization

European Union / Azithromycin administration / /

Position

General / /

Product

AZITHROMYCIN / hepatic function / /

PublishedMedium

the Worksharing PSUR review / /

Technology

Pharmacokinetics / dialysis / /

SocialTag