Code | 40769 | ||||||||||
MA number | EU/1/04/276/001 | ||||||||||
Product Form: | tbl 14x1x5 mg (perf.jednod.bli.Alu/Alu) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Otsuka Pharmaceutical Netherlands B.V., Netherland | ||||||||||
Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 04.06.2004 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 24.01.2019 |