| Code | 8435B | ||||||||||
| MA number | 65/0123/16-S | ||||||||||
| Product Form: | tbl flm 20x75 mg/25 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Menarini International Operations Luxembourg S.A., Luxembourg | ||||||||||
| Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
| ATC: | 
 | ||||||||||
| Shelf life: | 60 | ||||||||||
| Route of admin.: | Oral use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 10b fixed combination application | 
| MA issued: | 02.03.2016 | 
| Pediatric warnings: | Yes | 
| SPC: |  | 
| PIL: |  | 
| Safety feature | Yes | 
| Data update: | 05.05.2021 |