Code | 3215E | ||||||||
MA number | 94/0069/23-S | ||||||||
Product Form: | tbl obd 60x36 mg/36 mg/36 mg (blis.PVC/PVDC/Al) | ||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||
Type of procedure: | Mutual recognition procedure | ||||||||
MAH, country: | Bionorica SE, Germany | ||||||||
Therapeutic Class: | 94 - FYTOPHARMACA | ||||||||
ATC: |
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Shelf life: | 36 | ||||||||
Container: | blister PVC/PVDC/Al | ||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product not subject to medical prescription. |
Legal basis: | Article 10a well-established use application |
MA issued: | 18.05.2023 |
Validity: | 18.05.2028 |
MA renewed: | Renewal application submitted |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: |
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SPC: |
|
Safety feature | No |
Data update: | 26.05.2023 |