Nplate reconstitution kit *

  • 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 28 January 2021

File name

en_nplate_approved_pil_reconkit_v77 (IE + XI)_1611849711.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 28 January 2021

File name

en_nplate_approved_SPC_reconkit_v77 (IE and XI)_1611849582.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 12 January 2021

File name

en_nplate_approved_SPC_reconkit_v78_1610470520.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 02 June 2020

File name

en_nplate_approved_SPC_reconkit_psur18_1591086407.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)

EDM Updated on 31 March 2020

File name

HAT pack - Step-by-step-guide_1585661845.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 31 March 2020

File name

HAT pack - Checklist tearsheet_1585661528.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 31 March 2020

File name

HAT pack - Patient selection_1585661483.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 31 March 2020

File name

HAT pack - Quick Guide_1585661190.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 31 March 2020

File name

HAT pack - Prep Mat_1585660571.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 31 March 2020

File name

HAT pack - DVD label_1585660571.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 31 March 2020

File name

HAT pack - Dose Diary_1585660484.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 31 March 2020

File name

Dosing Calaculator_1585660350.pdf

Reasons for updating

  • Add New Doc

Updated on 30 March 2020

File name

UKIE_nplate_approved_SPC recon kit_v66_1585583179.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 30 March 2020

File name

en_nplate_approved_pil_recon kit_v66_1585583098.pdf

Reasons for updating

  • New PIL for new product