Code | 0765C | ||||||||||
MA number | 83/0374/16-S | ||||||||||
Product Form: | flm oro 8x50 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 | ||||||||||
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 |