| Code | 58838 | ||||||||||
| MA number | 13/0193/04-S | ||||||||||
| Product Form: | tbl flm 50x300 mg | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| MAH, country: | PRO.MED.CS Praha a.s., Czechia | ||||||||||
| Therapeutic Class: | 13 - ANTIARRYTHMICA | ||||||||||
| ATC: |
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| Shelf life: | 48 | ||||||||||
| Container: | blister Al/PVC | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 30.04.2004 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
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| PIL: |
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| Safety feature | Yes |
| Data update: | 27.02.2018 |