| Code | 3584E | ||||||||||
| MA number | 69/0087/23-S | ||||||||||
| Product Form: | pas ord 16x8,75 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | MAPAEX CONSUMER HEALTHCARE (IRELAND) PRIVATE LIMITED, Ireland | ||||||||||
| 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 10a well-established use application |
| MA issued: | 31.05.2023 |
| Validity: | 31.05.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Dokument: |
VHS_SK_H_0280_001_DC_Vocasept_EPAR.DOC
|
| Dokument: |
VHS_SK_H_0280_001_DC_Vocasept_summary EPAR.doc
|
| PIL: |
PIL_Vocasept_01/2024.pdf
|
| SPC: |
SPC_Vocasept_01/2024.pdf
|
| Safety feature | No |
| Data update: | 31.05.2023 |
