Code | 2703D | ||||||||||
MA number | 69/0336/19-S | ||||||||||
Product Form: | aer ors 1x15 ml (fľ.HDPE) | ||||||||||
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: | 24 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Oromucosal use |
Prescription Status: | Medicinal product not subject to medical prescription. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 04.11.2019 |
Validity: | 04.11.2024 |
MA renewed: | Renewal application submitted |
Pediatric contraindication: | Yes |
SPC: |
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PIL: |
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Safety feature | No |
Data update: | 08.06.2021 |