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PRODUCT DETAIL

Lotemax

Code 94463
MA number 64/0359/05-S
Product Form: int opu 1x10 ml/50 mg (fľ.LDPE)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Mutual recognition procedure
Therapeutic Class: 64 - OPHTHALMOLOGICA
ATC:
S SENSORY ORGANS
S01 OPHTHALMOLOGICALS
S01B ANTIINFLAMMATORY AGENTS
S01BA Corticosteroids, plain
S01BA14 Loteprednol
Shelf life: 24
Container: bottle LDPE
Route of admin.: Ocular use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 07.10.2005
Pediatric warnings: Yes
SPC: SPC_Lotemax_03.2021.pdf  
PIL: PIL_Lotemax_01.2022.pdf  
Safety feature Yes
Data update: 24.02.2020
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