New search Hide text from Guidelines
S SENSORY ORGANSA formulation approved both for use in the eye/ear is classified in S03. Formulations approved for eye, ear and nose are also classified in S03. Formulations only licensed for use in the eye or the ear are classified in S01 and S02, respectively.
S01 OPHTHALMOLOGICALS
Most of the drugs in this group are topical preparations. Systemic preparations with clear ophthalmological indications are also classified in this group.
Small amounts of antiseptics in eye preparations do not influence the classification, e.g. benzalconium.
See also S03 - Ophthalmological and otological preparations.
| DDDs have been assigned for antiglaucoma preparations only. |
S01A ANTIINFECTIVES
This group comprises plain and combined antiinfective preparations for ophthalmological use.
Combinations with corticosteroids are classified in S01CA - Corticosteroids and antiinfectives in combination.
This group comprises all eye preparations with non-steroidal antiinflammatory agents and corticosteroids, plain and combinations. Combinations with antiinfectives are classified in S01C - Antiinflammatory agents and antiinfectives in combination.
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
This group comprises all eye preparations, which contain corticosteroids or non-steroidal antiinflammatory agents and antiinfectives. Preparations may also contain additional drugs.
S01E ANTIGLAUCOMA PREPARATIONS AND MIOTICS
This group comprises preparations for local and systemic treatment of glaucoma.
Drugs used for producing miosis are classified in this group, even if the main indication is not glaucoma.
| The DDDs are based on single dose (or single package) and administration frequencies. A single dose is defined as two eye drops (one in each eye) corresponding to 0.1 ml. For eye drops administered once daily the DDD is 0.1 ml, for eye drops administered twice daily the DDD is 0.2 ml, etc. For single use packages one dose is the volume of one package. This also applies for combinations. In eye ointments one dose corresponds to about 10 mm (20 mg) per eye thus corresponding to 40 mg for both eyes. |
S01F MYDRIATICS AND CYCLOPLEGICS
S01G DECONGESTANTS AND ANTIALLERGICS
This group comprises drugs used to treat symptoms of e.g. allergy.
S01H LOCAL ANESTHETICS
This group comprises topical drugs used as local anesthetics in the eye.
Local anesthetics for other indications are classified in N01B - Anesthetics, local. Other exceptions, see comments to N01B.
Combinations of local anesthetics and diagnostic agents, e.g. fluorescein, are classified in S01J.
S01J DIAGNOSTIC AGENTS
This group comprises topical drugs used for diagnosing diseases in the eye. Mydriatics and cycloplegics used as diagnostic aids are classified in S01F.
Diagnostic agents for systemic use for ophthalmological diagnoses, e.g. fluorescein injection, are classified in V04CX - Other diagnostic agents.
S01K SURGICAL AIDS
This group comprises drugs used in ophthalmological surgery.
Miotics are classified in S01E - Antiglaucoma preparations and miotics.
Mydriatics and cycloplegics are classified in S01F.
S01L OCULAR VASCULAR DISORDER AGENTS
S01X OTHER OPHTHALMOLOGICALS
This group comprises 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.
Last updated: 2024-01-26