Code | 44301 | ||||||||||
MA number | 87/0284/07-S | ||||||||||
Product Form: | tbl flm 8x35 mg (blis. OPA/Al/PVC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Zentiva a.s., Slovakia | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
Container: | blister OPA/Al/PVC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 08.08.2007 |
SPC: | SPC_RISENDROS 35 mg_03.2020.doc |
PIL: | PIL_Risendros 35 mg_11.2020.doc |
Safety feature | Yes |
Data update: | 27.11.2018 |