Code | 3342E | ||||||||||
MA number | 64/0045/20-S | ||||||||||
Product Form: | int opo 3x5 ml (fľ.PE s kvapkadlom) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | UNIMED PHARMA, spol. s r.o., Slovakia | ||||||||||
Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | dropper bottle PE | ||||||||||
Route of admin.: | Ocular use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 13.03.2020 |
Validity: | 13.03.2025 |
MA renewed: | Renewal application submitted |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Dokument: | VHS_súhrn_Olopatadine UNIMED PHARMA.pdf |
Dokument: | VHS_Olopatadine UNIMED PHARMA.pdf |
PIL: | PIL_Olopatadine UNIMED PHARMA 1 mg_ml int opo_03.2023.pdf |
SPC: | SPC_Olopatadine UNIMED PHARMA 1 mg_ml int opo_03.2023.pdf |
Safety feature | Yes |
Data update: | 28.03.2023 |