Code | 8967E | ||||||||||
MA number | 58/0048/25-S | ||||||||||
Product Form: | tbl mod 56x80 mg/1,5 mg (blis.OPA/Al/PVC//Al) - kalend.bal. | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
Therapeutic Class: | 58 - HYPOTENSIVA | ||||||||||
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 medical prescription. |
Legal basis: | Article 10b fixed combination application |
MA issued: | 07.02.2025 |
Validity: | 07.02.2030 |
PIL: |
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SPC: |
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Safety feature | Yes |
Data update: | 13.02.2025 |