| Code | 1114D | ||||||||||
| MA number | EU/1/16/1135/002 | ||||||||||
| Product Form: | sol por 1x60 ml (fľ.skl.jantár.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| Therapeutic Class: | 53 - PARASYMPATHOLYTICA, GANGLIOPLEGICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | amber glass bottle | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 15.09.2016 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Sialanar_Karta pre opatrovateľov.pdf
|
| Dokument: |
Sialanar_Kontrolny zoznam - format.pdf
|
| Dokument: |
Sialanar_Kontrolny zoznam pre hodnotenie anticholinergickych neziaducich ucinkov.pdf
|
| Safety feature | Yes |
| Data update: | 19.04.2023 |
