| Code | 7576E | ||||||||||
| MA number | 69/0252/24-S | ||||||||||
| Product Form: | pas ord 24x2 mg /1,2 mg/0,6 mg (blis.PVC-PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Bayer, spol. s r.o., Slovakia | ||||||||||
| Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
| ATC: |
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| 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: | 24.09.2024 |
| Validity: | 24.09.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| PIL: |
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| SPC: |
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| Safety feature | No |
| Data update: | 24.09.2024 |