Code | 20095 | ||||||||||
MA number | EU/1/10/618/001 | ||||||||||
Product Form: | sol inj 1x1 ml/60 mg (striek.inj.napl.skl. v blistri) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Amgen Europe B.V., Netherland | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 26.05.2010 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | DHPC Prolia informačná karta pacienta.pdf |
Dokument: | DHPC Prolia 2 9 2014.pdf |
Dokument: | DHPC Prolia 14 2 2013.pdf |
Safety feature | Yes |
Data update: | 08.03.2024 |