Code | 9931C | ||||||||||
MA number | 64/0423/18-S | ||||||||||
Product Form: | int opo 1x5 ml (fľ.LDPE) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Olikla s.r.o., Czechia | ||||||||||
Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | bottle LDPE | ||||||||||
Route of admin.: | Ocular use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 18.12.2018 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Moxifloxacin Olikla 5 mg ml_int opo_10.2023.pdf |
SPC: | SPC_Moxifloxacin Olikla 5 mg ml_int opo_10.2023.docx |
Safety feature | Yes |
Data update: | 25.10.2023 |