Code | 7297D | ||||||||||
MA number | 64/0106/21-S | ||||||||||
Product Form: | int osd 15x0,3 ml (obal LDPE jednodávkový) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | SIFI S.p.A, Italy | ||||||||||
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: | 16.04.2021 |
Validity: | 16.04.2026 |
MA renewed: | Renewal application submitted |
Pediatric warnings: | Yes |
PIL: |
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SPC: |
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Safety feature | Yes |
Data update: | 31.08.2022 |