Code | 9779D | ||||||||||
MA number | EU/1/21/1622/001 | ||||||||||
Product Form: | tbl flm 90x500 mg (fľ.HDPE) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Pfizer Europe MA EEIG, Belgium | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
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: | 14.02.2022 |
Validity: | 14.02.2027 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 20.06.2023 |