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Denosumab

Prolia®

   
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Concentration
Price
08000181
60 mg/ml
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08000181
60 mg/ml
Note: For full product details, please login.
08000181
60 mg/ml
Note: For full product details, please login.
08000181
60 mg/ml
Note: For full product details, please login.
08000181
60 mg/ml
Note: For full product details, please login.
08000181
60 mg/ml
Note: For full product details, please login.

Drug name: Prolia®

INN: Denosumab

API type: Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.

Pharmacotherapeutic group: Drugs for the treatment of bone diseases – Other drugs affecting bone structure and mineralization

ATC code: M05BX04

General function:

Short description:

Original license holder:

Marketing authorisation numbers: EU/1/10/618/001 - 004

Marketing authorisation holder: Amgen Europe B.V.; Minervum 7061; 4817 ZK Breda; The Netherlands

Name of the manufacturer of the biological active substance: Amgen Europe B.V.; Minervum 7061; 4817 ZK Breda; The Netherlands

Name and address of the manufacturer responsible for batch release:

Max shelf life: 36 months

Storage conditions: 2°C – 8°C

List of excipients: Acetic acid, glacial*, Sodium hydroxide (for pH adjustment)*, Sorbitol (E420), Polysorbate 20, Water for injections
* Acetate buffer is formed by mixing acetic acid with sodium hydroxide