| Code | 0761C | ||||||||||
| MA number | 83/0376/16-S | ||||||||||
| Product Form: | flm oro 8x100 mg (vre.PET) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | IBSA Slovakia s.r.o., Slovakia | ||||||||||
| Therapeutic Class: | 83 - VASODILATANTIA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | sachet PET | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 08.08.2016 |
| SPC: |
SPC_SILANDYL_flm oro_10_2022.pdf
|
| PIL: |
PIL_SILANDYL_flm oro_01_2024.pdf
|
| Safety feature | Yes |
| Data update: | 15.11.2022 |
