美国

Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799

Patent: http://pat.amgen.com/prolia/ 

© 2010-2017 Amgen Inc.  All rights reserved.

1 x 60 mg Single Use Prefilled Syringe
NDC 55513-710-01
AMGEN®
prolia®
(denosumab)
60 mg/mL
60 mg/mL Injection – For Subcutaneous Use Only.
Single Use Prefilled Syringe. Discard unused portion.
Sterile Solution – No Preservative.
Rx Only
Refrigerate at 2° to 8°C (36° to 46°F). Do not freeze. Avoid excessive shaking. Protect from direct light and heat.
This Product Contains Dry Natural Rubber.
Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799

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• INGREDIENTS AND APPEARANCE

  Product Information

  PROLIA  denosumab injection

  Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-710 Route of Administration SUBCUTANEOUS

  Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DENOSUMAB (UNII: 4EQZ6YO2HI) (DENOSUMAB - UNII:4EQZ6YO2HI) DENOSUMAB 60 mg  in 1 mL

  Inactive Ingredients Ingredient Name Strength SODIUM ACETATE (UNII: 4550K0SC9B) 1 mg  in 1 mL POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.1 mg  in 1 mL SORBITOL (UNII: 506T60A25R) 47 mg  in 1 mL WATER (UNII: 059QF0KO0R)

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55513-710-01 1 in 1 CARTON 06/05/2010   1   1 mL in 1 SYRINGE; Type 0: Not a Combination Product

  Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125320 06/05/2010

爱尔兰 Prolia (denosumab) Important Safety Information from Amgen Ireland Limited as approved by the Irish Medicines Board

Notice type: 3rd Party Publications

Date: 21/02/2013

 

Problem Or Issue:
Important Safety Information communication from Amgen Ireland Limited on the risk of atypical femoral fracture associated with the use of denosumab.

Important Safety Information - Prolia (denosumab)    

The patient information leaflet you have selected is in PDF format.

View Patient Information Leaflet (0.677MB)

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Medicine Name	Active Ingredients	Company Name	Last medicines.ie Update
Prolia	Denosumab	Amgen Ltd	30-Jun-17
Prolia	Denosumab	Amgen Ltd	30-Jun-17

Prolia is a clear, colourless to slightly yellow solution for injection provided in a ready to use prefilled syringe. 
 
Each pack contains one pre-filled syringe with a needle guard. Each pack contains one pre-filled syringe.
 
Marketing Authorisation Holder and Manufacturer: Amgen Europe B.V. Minervum 7061  4817 ZK Breda The Netherlands
 
Marketing Authorisation Holder: Amgen Europe B.V. Minervum 7061  4817 ZK Breda The Netherlands
 
Manufacturer: Amgen Technology (Ireland) Unlimited Company Pottery Road Dun Laoghaire Co Dublin Ireland
 
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
 
United Kingdom Amgen Limited Tel: +44 (0)1223 420305
 
Ireland Amgen Limited United Kingdom Tel: +44 (0)1223 420305
 
Malta

 
7
Amgen B.V. The Netherlands Tel: +31 (0)76 5732500
 
This leaflet was last revised in June 2017.

PROLIA

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 CardHet kan voorkomen dat uw ziekte/klacht niet wordt genoemd in de gedrukte bijsluiter van het medicijn dat de arts aan u voorschrijft. Dit komt voor bij medicijnen waarvoor een octrooi van een andere vergunninghouder geldt op het gebruik van het middel bij uw ziekte/klacht. De fabrikant van het medicijn mag dit gebruik dan niet vermelden in de gedrukte bijsluiter. In dat geva l staat er in de bijsluiter die u hier kunt downloaden een sterretje achter deze ziekte/klacht. Op de pagina Vragen en antwoorden over gebruiksoctrooien en bijsluiters vindt u hierover meer informatie.
 

SmPC, etiket en patiëntenbijsluiterAdditionele risicominimalisatie materialen

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