| Code | 3558C | ||||||||||
| MA number | 65/0108/17-S | ||||||||||
| Product Form: | tbl plg 50x1x40 mg/20 mg (blis.PVC/PVDC/PET/Al-jednotliv.bal.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
| Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 12.04.2017 |
| Pediatric warnings: | Yes |
| SPC: |
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| PIL: |
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| Safety feature | Yes |
| Data update: | 04.11.2021 |