Code | 4375A | ||||||||||
MA number | 15/0076/13-S | ||||||||||
Product Form: | tbl flm 14x550 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Alfasigma S.p.A., Italy | ||||||||||
Therapeutic Class: | 15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PVC/PE/PVDC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 05.03.2013 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
PIL: | PIL_REFERO 550 mg tbl flm_05.2021.pdf |
SPC: | SPC_REFERO 550 mg tbl flm_09.2022.pdf |
Safety feature | Yes |
Data update: | 30.04.2018 |