Code | 8762E | ||||||||||
MA number | 69/0028/25-S | ||||||||||
Product Form: | pas ord 16x8,75 mg (blis.PVC/PVdC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Reckitt Benckiser (Czech Republic), spol. s r.o. , Czechia | ||||||||||
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: | 15.02.2025 |
Validity: | 15.02.2030 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
SPC: |
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PIL: |
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Safety feature | No |
Data update: | 04.03.2025 |