Code | 8568C | ||||||||||
MA number | 69/0266/18-S | ||||||||||
Product Form: | aer nao 1x10 ml (fľ.HDPE) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Haleon Czech Republic s.r.o., Czechia | ||||||||||
Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
ATC: |
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Shelf life: | 30 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Nasal use |
Prescription Status: | Medicinal product not subject to medical prescription. |
Legal basis: | Article 10(3) hybrid application |
MA issued: | 22.08.2018 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
PIL: | PIL_Otrivin Plus 1 mg/ml + 50 mg/ml_12/2023.pdf |
SPC: | SPC_Otrivin Plus 1 mg/ml + 50 mg/ml_12/2023.pdf |
Safety feature | No |
Data update: | 21.09.2023 |