| Code | 7815E | ||||||||||
| MA number | 87/0285/24-S | ||||||||||
| Product Form: | gas mcp 1x10 l (150 bar) (fľ.Al na stlač.plyn) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | SOL SpA, Italy | ||||||||||
| Therapeutic Class: | 14 - BRONCHODILATANTIA, ANTIASTHMATICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | gas cylinder | ||||||||||
| Route of admin.: | Inhalation use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 27.11.2024 |
| Validity: | 27.11.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Neophyr_11 2024.pdf
|
| SPC: |
SPC_Neophyr_11 2024.pdf
|
| Dokument: |
Neophyr_Príručka pre zdravotníckych pracovníkov.pdf
|
| Safety feature | No |
| Data update: | 02.12.2024 |
