Code | 5453B | ||||||||||
MA number | EU/1/15/1005/004 | ||||||||||
Product Form: | tbl 14x10 mg (blis.(PA/Al/PVC/Al) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Mylan Pharmaceuticals Limited, Ireland | ||||||||||
Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister PA/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: | 30.06.2015 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 13.03.2020 |