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.
Small amounts of antiseptics in eye preparations do not influence the classification, e.g. benzalconium.
See also S03 - Ophthalmological and otological preparations.
S01X OTHER OPHTHALMOLOGICALS
This group comprises topical products, which cannot be classified in the preceding groups e.g. artificial tears, products for use with contact lenses, drugs against cataract etc.
All products containing boric acid are classified in S01AX - Other antiinfectives.
S01XA Other ophthalmologicals
Hypromellose is classified in S01XA20, if it is used as artificial tears. See also S01KA.
Last updated: 2013-12-19