Code | 4813C | ||||||||||
MA number | 64/0213/17-S | ||||||||||
Product Form: | int osd 60(6x10)x0,4 ml (obal LDPE-jednodávkový) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Laboratoires THEA, France | ||||||||||
Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | LDPE single-dose container | ||||||||||
Route of admin.: | Ocular use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 07.08.2017 |
Pediatric warnings: | Yes |
SPC: | SPC_Softacort_04.2019.doc |
PIL: | PIL_Softacort_12.2023.pdf |
Safety feature | Yes |
Data update: | 24.08.2022 |