Code | 5505C | ||||||||||
MA number | 68/0144/07-S | ||||||||||
Product Form: | tbl flm 50x200 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
ATC: |
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Shelf life: | 60 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 30.04.2007 |
Pediatric warnings: | Yes |
SPC: |
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PIL: |
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Safety feature | Yes |
Data update: | 25.05.2018 |