| Code | 0336F | ||||||||||
| MA number | 73/0217/25-S | ||||||||||
| Product Form: | tbl flm 30x10 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | J.J. Bishop Health a.s., Czechia | ||||||||||
| Therapeutic Class: | 73 - SPASMOLYTICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 16.07.2025 |
| Validity: | 16.07.2030 |
| SPC: |
SPC_Solifenacin SaneXcel 10 mg_tbl flm_07/2025_REG.pdf
|
| PIL: |
PIL_Solifenacin SaneXcel 5 mg, 10 mg_tbl flm_07/2025_REG.pdf
|
| Safety feature | Yes |
| Data update: | 17.07.2025 |
