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PRODUCT DETAIL

Ospolot 20 mg/ml perorálna suspenzia

Code 7807E
MA number 21/0266/24-S
Product Form: sus por 1x250 ml/5 g (fľ.skl.jantár)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
MAH, country: Desitin Arzneimitttel GmbH, Germany
Therapeutic Class: 21 - ANTIEPILEPTICA, ANTICONVULSIVA
ATC:
N NERVOUS SYSTEM
N03 ANTIEPILEPTICS
N03A ANTIEPILEPTICS
N03AX Other antiepileptics
N03AX03 Sultiame
Shelf life: 36
Container: amber glass bottle
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(3) hybrid application
MA issued: 10.12.2024
Validity: 10.12.2029
Pediatric indication: Yes
Pediatric posology: Yes
SPC: SPC_Ospolot 20 mg_ml_perorálna suspenzia_11.2024.pdf  
PIL: PIL_Ospolot 20 mg_ml_perorálna suspenzia_11.2024.pdf  
Safety feature Yes
Data update: 11.12.2024
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