Code | 5165B | ||||||||||
MA number | 69/0311/15-S | ||||||||||
Product Form: | pas ord 24x3 mg/1 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
Container: | blister PVC/PE/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: | 27.07.2015 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
PIL: |
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SPC: |
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Safety feature | No |
Data update: | 27.09.2022 |