Code | 0462D | ||||||||||
MA number | EU/1/18/1331/001 | ||||||||||
Product Form: | con sol 1x0,5 ml + 2x1,7 ml solv. (liek.inj. COC) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Novartis Europharm Limited, Ireland | ||||||||||
Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
ATC: |
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Shelf life: | 36 |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 22.11.2018 |
Validity: | 05.12.2028 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | Luxturna_karta pacienta_vacsi format.pdf |
Dokument: | Luxturna_karta pacienta_mensi format.pdf |
Dokument: | Luxturna_pisomna informacia pre pouzivatela_vacsi format.pdf |
Dokument: | Luxturna_karta pacienta_audio.mp3 |
Safety feature | Yes |
Data update: | 18.08.2023 |