| Code | 6814C | ||||||||||
| MA number | 65/0024/18-S | ||||||||||
| Product Form: | vap inl 1x3 ml (fľ.skl.+inhalátor+zásobník s aktiv.uhlím) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Medical Developments NED B.V. , Netherland | ||||||||||
| Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | glass bottle | ||||||||||
| Route of admin.: | Inhalation use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 25.01.2018 |
| Pediatric posology: | Yes |
| Dokument: |
Penthrox Kontrolný zoznam pred podaním.pdf
|
| Dokument: |
Penthrox Sprievodca pre použite.pdf
|
| Dokument: |
Penthrox Bezpečnostná karta pacienta.pdf
|
| SPC: |
SPC_Penthrox_09.2025.pdf
|
| PIL: |
PIL_Penthrox_09.2025.pdf
|
| Safety feature | Yes |
| Data update: | 31.03.2023 |
