Parsabiv
*Company:
Amgen Ireland LtdStatus:
No Recent UpdateLegal 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
Updated on 03 February 2023
File name
en_parsabiv_approved_SPC_r17 - NI and IE.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 September 2021
File name
en_parsabiv_approved_PIL_r17 - NI and IE.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.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.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.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.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.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.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.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.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