Code | 8316C | ||||||||||
MA number | 64/0072/13-S | ||||||||||
Product Form: | int osd 10(1x10)x0,2 ml (obal LDPE jednodáv.) | ||||||||||
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: | 27.02.2013 |
SPC: | SPC_Monopost_v jednodávkovom obale_05.2022.pdf |
PIL: | PIL_MONOPOST 50 mikrogramov_ml int osd_03.2024.pdf |
Safety feature | Yes |
Data update: | 09.01.2020 |