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M265: Dosage restriction limits / Language
M265: Dosage restriction limits / Language

Dosage restriction limits / Language [M265]

Updated over 3 years ago

Status: Optional

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

Repeatability attribute in group: ✓

Definition

Indication of the dosage limitation of the drug or supplement. Examples: Do not exceed 8 tablets per day, Do not take for more than 14 days. This may - or in some target markets must - be indicated on the product (e.g. in the EU for finished medicinal products according to "Directive 2001/83/EC of 6 November 2001").

Explanation

The indication of dosage restrictions and side effects is required by law for finished medicinal products. 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 provided, the corresponding language must also be transmitted.

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