| Code | 4296E | ||||||||||
| MA number | 69/0201/23-S | ||||||||||
| Product Form: | pas ord 24x8,75 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
| Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oromucosal use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 18.09.2023 |
| Validity: | 18.09.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Dokument: |
VHS_Vocafen_SK_H_0293_001_DC_EPAR.DOC
|
| Dokument: |
VHS_Vocafen_SK_H_0293_001_DC_EPAR summary.doc
|
| SPC: |
SPC_Oroflurb pastilky_06/2024.pdf
|
| PIL: |
PIL_Oroflurb pastilky s pomarančovou príchuťou_03/2025.pdf
|
| Safety feature | No |
| Data update: | 30.05.2024 |
