| Code | 1736F | ||||||||||
| MA number | 69/0368/25-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: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oropharyngeal use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 27.10.2025 |
| Validity: | 27.10.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Vocasept s pomarančovou príchuťou bez cukru 8,75 mg tvrdé pastilky_10_2025.pdf
|
| SPC: |
SPC_Vocasept s pomarančovou príchuťou bez cukru 8,75 mg tvrdé pastilky_10_2025.pdf
|
| Safety feature | No |
| Data update: | 28.10.2025 |
