Code | 2345E | ||||||||||
MA number | EU/1/22/1672/002 | ||||||||||
Product Form: | tbl flm 56x200 mg (fľ.HDPE) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Takeda Pharmaceuticals International AG Ireland Branch, Ireland | ||||||||||
Therapeutic Class: | 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK) | ||||||||||
ATC: |
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Shelf life: | 30 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 09.11.2022 |
Validity: | 09.11.2027 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 22.11.2022 |