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What is the available information on the effect and dosage of polyols on newborn babies during the first months?

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In Europe the pharmaceutical field does not impose any special restrictions on the inclusion of polyols in medicines for newborn babies, and this for the quite simple and valid reason that the medicine will be assessed on all its aspects via the AMM file.

The only known regulatory constraints are those of the European guidelines relating to excipients with well-known effects (EU guideline, July 2003).

Other questions - General

Does Roquette as a manufacturer has to perform identification tests?

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How does sorbitol ingestion influence blood glycemia?

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Can a generic manufacturer use a different ingredient/excipient while still submitting drug as a generic?

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What is the viscosity's of a non-crystalising liquid sorbitol such as NEOSORB 70/70 B?

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