Code | 4058B | ||||||||||
MA number | 64/0171/15-S | ||||||||||
Product Form: | int opu 1x5 ml/50 mg (fľ.LDPE) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Bausch + Lomb Ireland Limited, Ireland | ||||||||||
Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
ATC: |
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Shelf life: | 30 | ||||||||||
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: | 12.05.2015 |
Pediatric warnings: | Yes |
PIL: | PIL_Brizadopt_04/2024.pdf |
SPC: | SPC_Brizadopt_04/2024.pdf |
Safety feature | Yes |
Data update: | 11.01.2022 |