A formulation approved both for use in the eye/ear is classified in S03, while formulations only licensed for use in the eye or the ear are classified in S01 and S02, respectively.
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
This group comprises preparations which can be used in both eye and ear.
Small amounts of antiseptics (e.g. benzalconium) in eye/ear preparations do not influence the classification.
This group comprises plain and combined antiinfective preparations for use in eye/ear.
Combined preparations are classified at a separate 5th level, S03AA30 - antiinfectives, combinations. This level includes combinations of different antiinfectives and combinations of antiinfectives and other substances.
Combinations with corticosteroids are classified in S03C - Corticosteroids and antiinfectives in combination.
Last updated: 2013-12-19