| Code | 9729A | ||||||||||
| MA number | EU/1/14/913/014 | ||||||||||
| Product Form: | tbl flm 98x1x37 mg (blis.Al/Al-jednod.bal.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F.SpA, Italy | ||||||||||
| Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
| ATC: |
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| Shelf life: | 60 | ||||||||||
| Container: | blister Al/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 21.03.2014 |
| SmPC + PL: |
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| Safety feature | Yes |
| Data update: | 09.11.2021 |