Code | 7332E | ||||||||||
MA number | EU/1/24/1850/004 | ||||||||||
Product Form: | plv iol 2x60 mg + 2x1,3 ml solv. (liek.inj.skl.+striek.inj.napl.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Merck Sharp & Dohme B.V., Netherland | ||||||||||
Therapeutic Class: | 58 - HYPOTENSIVA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 22.08.2024 |
Validity: | 22.08.2029 |
SmPC + PL: | European Medicines Agency's database |
Safety feature | Yes |
Data update: | 04.09.2024 |