Code | 4020E | ||||||||||
MA number | EU/1/21/1550/003 | ||||||||||
Product Form: | tbl flm 84 (3x28)x20 mg (blis.OPA/alu/PE+DES/PET/alu/PE) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Janssen - Cilag International N.V., Belgium | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
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: | 19.05.2021 |
Validity: | 19.05.2026 |
SmPC + PL: |
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Safety feature | Yes |
Data update: | 14.07.2023 |