Prolia

Pharmacy Only: Prescription

Company:
Amgen Ireland Ltd
Status:
Updated
Legal Category:
Product subject to medical prescription which may not be renewed (A)
Active Ingredient(s):
Denosumab
*Additional information is available within the SPC or upon request to the company

SPC
Patient Leaflets
Ed Material - Patient
Licence Info
Doc History

Licence number

Strength

ATC code

Dosage form

EU/1/10/618/1-4

60 milligram(s)/millilitre

M05BX04

Solution for injection

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The Summary of Product Characteristics (SPC) is a specific document, the wording of which has been agreed with the regulatory authority as part of the medicine approval process. It is required before any medicine is allowed on the market in Europe. It is designed to assist doctors and pharmacists in prescribing and supplying the product.

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Documents associated with this medicine were updated in the last 30 days.

''Company'' may refer to either the Marketing Authorization Holder (MAH), the company responsible for marketing the product in Ireland and/or responsible for uploading documents pertaining to the product onto Medicines.ie. To determine the MAH, please consult the actual submitted documents.

Prolia

Company:

Status:

Legal Category:

Active Ingredient(s):