Nplate reconstitution kit *
Pharmacy Only: Prescription

  • 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

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