| Code | 2029F | ||||||||||
| MA number | 68/0407/25-S | ||||||||||
| Product Form: | sus por 1x60 ml/1,5 g (fľ.skl.+adaptér, striekačka 5 ml, odmerka 20 ml) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Exeltis Slovakia s.r.o., Slovakia | ||||||||||
| Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 01.01.2026 |
| Validity: | 01.01.2031 |
| Pediatric warnings: | Yes |
| PIL: |
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| SPC: |
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| Safety feature | Yes |
| Data update: | 07.01.2026 |