Code | 1262D | ||||||||||
MA number | 73/0118/19-S | ||||||||||
Product Form: | tbl flm 60x5 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Novatin Limited, Malta | ||||||||||
Therapeutic Class: | 73 - SPASMOLYTICA | ||||||||||
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: | 29.04.2019 |
MA renewed: | Renewal application submitted |
PIL: | PIL_Retrim 5mg_Retrim 10 mg_tbl flm_09_2024.pdf |
SPC: | SPC_Retrim 5mg_Retrim 10 mg_tbl flm_09_2024.pdf |
Safety feature | Yes |
Data update: | 04.01.2024 |