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M264: Dosage recommendation / Language
M264: Dosage recommendation / Language

Dosage recommendation / Language [M264]

Updated over 3 years ago

Status: Optional

Format: an..2500 (alphanumeric, maximum 2500 digits)

Repeatability attribute in group: ✓

Definition

Recommendations, i.e. instructions for use of the dosage of the drug or supplement, e.g. type and, if necessary, route and frequency of administration, (if necessary also with indication of the exact time). Example: 2 tablets every 4 hours, 1 teaspoon daily. Dosage information is required by law for finished medicinal products in some target markets (e.g. in the EU for finished medicinal products according to "Directive 2001/83/EC of 6 November 2001").

Explanation

The obligation for the package insert with certain contents results for the countries of the European Union from the "Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use".

Conditions

If a text is specified, the corresponding language must also be transmitted.

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