| Code | 3665E | ||||||||||
| MA number | 64/0137/23-S | ||||||||||
| Product Form: | int opo 1x7,5 ml (fľ.LDPE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Bausch + Lomb Ireland Limited, Ireland | ||||||||||
| Therapeutic Class: | 64 - OPHTHALMOLOGICA | ||||||||||
| ATC: | 
                
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| Shelf life: | 24 | ||||||||||
| Container: | bottle LDPE | ||||||||||
| Route of admin.: | Ocular use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 8(3) application - known active substance | 
| MA issued: | 30.06.2023 | 
| Validity: | 30.06.2028 | 
| Pediatric warnings: | Yes | 
| SPC: | 
            
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| PIL: | 
            
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| Safety feature | Yes | 
| Data update: | 06.07.2023 |