Code | 78612 | ||||||||||
MA number | 64/0460/09-S | ||||||||||
Product Form: | int opo 90 (9x10)x0,3 ml/4,5 µg (obal LDPE jednodávk.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Santen Oy, Finland | ||||||||||
Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | LDPE single-dose container | ||||||||||
Route of admin.: | Ocular use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 30.07.2009 |
SPC: |
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PIL: |
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Safety feature | Yes |
Data update: | 16.05.2018 |