| Code | 36584 | ||||||||||
| MA number | 13/0415/06-S | ||||||||||
| Product Form: | tbl 100x50 mg (kon.PP) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Sandoz Pharmaceuticals d.d., Slovenia | ||||||||||
| Therapeutic Class: | 13 - ANTIARRYTHMICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 09.10.2006 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Flekainid Sandoz 50 mg tablety_tbl_08_2021.pdf
|
| PIL: |
PIL_Flekainid Sandoz_tbl_08_2021.pdf
|
| Safety feature | Yes |
| Data update: | 09.01.2019 |
