Parsabiv *

  • Company:

    Amgen Ireland Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

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.

Updated on 21 September 2021

File name

en_parsabiv_approved_PIL_r17 - NI and IE_1632241615.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains

Updated on 21 September 2021

File name

en_parsabiv_approved_SPC_r17 - NI and IE_1632241510.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 13 September 2021

File name

gb_parsabiv_approved_pil_creationofdedicatedpack - GB_1631570787.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder
  • Change to date of revision

Updated on 12 January 2021

File name

en_parsabiv_approved_SPC_v15_1610470249.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 27 March 2019

File name

en_parsabiv_approved_pil_v10_1553683380.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 27 March 2019

File name

en_parsabiv_approved_smpc_v10_1553683695.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 10 October 2018

File name

en_parsabiv_approved_smpc_v11_1539173094.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.3 - Shelf life

Extension from 3 yers to 4 years

Section 10 - Date of revision of the text

Updated to October 2018

Updated on 29 August 2018

File name

en_parsabiv_approved_pil_PSURv2_1535557176.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 29 August 2018

File name

en_parsabiv_approved_spc_PSURv2_1535557699.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 Addition of hypersensitivity reactions as an unknown frequency AE

Section 10, date of revision changed to August 2018

File name

en_parsabiv_approved_pil_v01.pdf

Updated on 21 May 2018

File name

en_parsabiv_approved_smpc_v01.docx

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

New product

Updated on 18 May 2018

File name

en_parsabiv_approved_pil_v01.pdf

Reasons for updating

  • New PIL for new product