| 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 |
| PIL: |
PIL_Strepfen Sprej Med a Citron_05/2025.pdf
|
| SPC: |
SPC_Strepfen Sprej Med a Citrón 8,75 mg_05/2025.pdf
|
| Safety feature | No |
| Data update: | 08.06.2021 |
