What is the available information on the effect and dosage of polyols on newborn babies during the first months?
See answer
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).
The only known regulatory constraints are those of the European guidelines relating to excipients with well-known effects (EU guideline, July 2003).