Code | 0350D | ||||||||||
MA number | 42/0026/19-S | ||||||||||
Product Form: | tbl flm 30x1x1 mg (blis.Al/OPA/Al/PVC-jednotliv.dáv.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Farmak International Sp. z o.o., Poland | ||||||||||
Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 30.01.2019 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: |
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SPC: |
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Safety feature | Yes |
Data update: | 16.10.2023 |