| Code | 9568C | ||||||||||
| MA number | EU/1/18/1316/003 | ||||||||||
| Product Form: | cps dur 7x1x5 mg (blis.OPA/Al/PVC/Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Accord Healthcare S.L.U, Spain | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 20.09.2018 |
| SmPC + PL: |
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| Safety feature | Yes |
| Data update: | 30.08.2023 |