Code | 0186D | ||||||||||
MA number | 64/0002/19-S | ||||||||||
Product Form: | int opo 1x2,5 ml (fľ.HDPE) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Bausch + Lomb Ireland Limited, Ireland | ||||||||||
Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Ocular use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 18.01.2019 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: |
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SPC: |
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Safety feature | Yes |
Data update: | 05.01.2024 |