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: |
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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: |
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PIL: |
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Safety feature | Yes |
Data update: | 11.12.2024 |