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| - M Lipanthyl S 215 mg je indikován jako doplněk k dietě a jiné nefarmakologické léčbě (např. cvičení, snižování hmotnosti) v následujících případech:
Léčba závažné hypertriglyceridémie s nízkým HDL cholesterolem nebo bez něj.
Smíšená hyperlipidémie, kdy je léčba statiny kontraindikována nebo není tolerována.
odify or delete the sample text provided below:
The indication(s) should define the target disease or condition distinguishing between treatment (symptomatic, curative or modifying the evolution or progression of the disease), prevention (primary or secondary) and diagnostic indication. When appropriate it should also define the target population. When the target population is wider than the clinical trial populations included in the main efficacy studies, this should be justified in the application.
Study endpoints should not normally be included unless such mention is specified as being appropriate for the indication in Committee for Medicinal Products for Human Use (CHMP) Notes for Guidance or Points to Consider Documents. The objective of a prevention indication may be mentioned in general terms only. This should also be done for the target population.
Mandatory conditions of product usage not covered more appropriately in other parts of the SPC may also be included when relevant, eg, concomitant dietary measures, lifestyle changes, or other therapy.
When the product is indicated in a specific age group such as children/adolescents, the indication should state the age limit.
MACROBUTTON nomacro {Invented Name} is indicated in MACROBUTTON nomacro <enter children or adolescents> from the age of MACROBUTTON nomacro <enter age in months or years>.
Where results from subsequent studies provide further definition or information on a licensed indication, such information, provided it does not itself constitute a new indication, may be considered for inclusion in Section 5.1.
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