Code | 8816E | ||||||||||
MA number | 24/0030/25-S | ||||||||||
Product Form: | tbl flm 500x180 mg (fľ.HDPE) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Viatris Limited, Ireland | ||||||||||
Therapeutic Class: | 24 - ANTIHISTAMINICA, HISTAMIN | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 36 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 07.02.2025 |
Validity: | 07.02.2030 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
SPC: |
|
PIL: |
|
Safety feature | Yes |
Data update: | 10.02.2025 |