Code | 4354D | ||||||||||
MA number | 29/0096/20-S | ||||||||||
Product Form: | tbl flm 60x300 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
Therapeutic Class: | 29 - ANTIRHEUMATICA, ANTIPHLOGISTICA, ANTIURATICA | ||||||||||
ATC: |
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Shelf life: | 24 | ||||||||||
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: | 22.05.2020 |
Validity: | 22.05.2025 |
MA renewed: | Renewal application submitted |
SPC: | SPC_Dexibuprofén Strides_tbl flm_04.2020_reg.docx |
PIL: | PIL_Dexibuprofén Strides 300 mg filmom obalené tablety_10.2023.pdf |
Safety feature | Yes |
Data update: | 27.05.2020 |