Code | 0269D | ||||||||||
MA number | 87/0008/19-S | ||||||||||
Product Form: | cps dur 14x1x100 mg (blis.PVC/PE/PCTFE/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Accord Healthcare Polska Sp. z o.o., Poland | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
Container: | blister PVC/PE/PCTFE/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 24.01.2019 |
SPC: | SPC_Miglustat Accord_04.2023.pdf |
PIL: | PIL_Miglustat Accord_04.2023.pdf |
Safety feature | Yes |
Data update: | 04.01.2024 |