| Code | 3289D | ||||||||||
| MA number | EU/1/19/1410/001 | ||||||||||
| Product Form: | aer nao 1x28 mg (liek.skl.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Janssen - Cilag International N.V., Belgium | ||||||||||
| Therapeutic Class: | 30 - ANTIDEPRESSIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 48 | ||||||||||
| Container: | glass container | ||||||||||
| Route of admin.: | Nasal use |
| Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 18.12.2019 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
SPRAVATO_Príručka prezdravotníckych pracovníkov.pdf
|
| Dokument: |
SPRAVATO_Príručka pre pacientov.pdf
|
| Dokument: |
SPRAVATO_Kontrolný zoznam pre lekárov.pdf
|
| Safety feature | Yes |
| Data update: | 11.09.2024 |
