| Code | 8466C | ||||||||||
| MA number | EU/1/18/1284/001 | ||||||||||
| Product Form: | tbl slg 5x1x30 µg (apl.PP - jednodávk.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Laboratoire AGUETTANT, France | ||||||||||
| Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
| ATC: | 
 | ||||||||||
| Shelf life: | 48 | ||||||||||
| Route of admin.: | Sublingual use | 
| Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. | 
| Legal basis: | Article 10(3) hybrid application | 
| MA issued: | 25.06.2018 | 
| SmPC + PL: |  | 
| Safety feature | Yes | 
| Data update: | 11.04.2023 |