Code | 3998E | ||||||||||
MA number | EU/1/23/1737/001 | ||||||||||
Product Form: | cps dur 4x65 mg (fľ.HDPE) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Amicus Therapeutics Europe Limited, Ireland | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 26.06.2023 |
Validity: | 26.06.2028 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 07.07.2023 |