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PRODUCT DETAIL

Spersadex comp.

Code 76499
MA number 64/0165/95-S
Product Form: int opo 1x5 ml (fľ.LDPE)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
Therapeutic Class: 64 - OPHTHALMOLOGICA
ATC:
S SENSORY ORGANS
S01 OPHTHALMOLOGICALS
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01CA Corticosteroids and antiinfectives in combination
S01CA01 Dexamethasone and antiinfectives
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: 06.04.1995
Pediatric contraindication: Yes
Pediatric warnings: Yes
SPC: SPC_Spersadex_07.2019.doc  
PIL: PIL_Spersadex_11.2020.doc  
Safety feature Yes
Data update: 05.06.2018
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