Prolia(德尼单抗[Dnosumab])-治疗男性骨折高危风险骨质疏松症
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Werkzame stof: |
DENOSUMAB |
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Hulpstoffen: |
AZIJNZUUR (E 260), GECONCENTREERD
NATRIUMHYDROXIDE (E 524)
POLYSORBAAT 20 (E 432)
SORBITOL (D-)(E 420)
STIKSTOF (HEAD SPACE) (E 941)
WATER VOOR INJECTIE |
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Name |
Prolia |
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Agency product number |
EMEA/H/C/001120 |
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Active substance |
denosumab
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International non-proprietary name (INN) or common name |
denosumab
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Therapeutic area |
Osteoporosis, PostmenopausalBone Resorption |
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Anatomical therapeutic chemical (ATC) code |
M05BX04 |
Publication details
Publication details for Prolia
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Marketing-authorisation holder |
Amgen Europe B.V.
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Revision |
14 |
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Date of issue of marketing authorisation valid throughout the European Union |
26/05/2010 |
Contact address:
Amgen Europe B.V.
Minervum 7061
NL-4817 ZK Breda
The Netherlands
60 Mg/Ml Solution for Injection
Amgen Europe B.V.EU/1/10/618/1-4
Main Information
Trade NamePROLIA
Active SubstancesDENOSUMAB
Strength60 Mg/Ml
Dosage FormSolution for Injection
Licence HolderAmgen Europe B.V.
Licence NumberEU/1/10/618/1-4
Group Information
ATC CodeM05BX04 Other drugs affecting bone structure and mineralization
Status
Authorised/WithdrawnAuthorised
Licence Issued26/05/2010
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of Licence
Documents
Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
Educational Materials - Patient
Patient Reminder Card
