Nplate reconstitution kit
*Company:
Amgen Ireland LtdStatus:
UpdatedLegal 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 25 September 2025
File name
ie_nplate_approved_spc_reconkit_CDSv21.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of section 4.8 of the SmPC to remove language regarding the testing for suspected neutralizing antibodies.
Updated on 10 March 2025
File name
ie_nplate_approved_SPC_reconkit_cdsv20.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
updated Thrombotic/thromboembolic complications section
updated Tabulated list of adverse reactions: deep vein thrombosis from uncommon to common
Updated on 10 March 2025
File name
ie_nplate_approved_leaflet_reconkit_cds v20.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Updated to included deep vein thrombosis
Updated on 03 February 2023
File name
en_nplate_approved_SPC_reconkit_v77 (IE and XI).pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 December 2022
File name
en_nplate_approved_pil_n82 reconkit.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 28 January 2021
File name
en_nplate_approved_pil_reconkit_v77 (IE + XI).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).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.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.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)
File name
HAT pack - Step-by-step-guide.pdf
Reasons for updating
- Add New Doc
File name
HAT pack - Checklist tearsheet.pdf
Reasons for updating
- Add New Doc
File name
HAT pack - Patient selection.pdf
Reasons for updating
- Add New Doc
File name
HAT pack - Quick Guide.pdf
Reasons for updating
- Add New Doc
File name
HAT pack - DVD label.pdf
Reasons for updating
- Add New Doc
File name
HAT pack - Prep Mat.pdf
Reasons for updating
- Add New Doc
File name
HAT pack - Dose Diary.pdf
Reasons for updating
- Add New Doc
File name
Dosing Calaculator.pdf
Reasons for updating
- Add New Doc
Updated on 30 March 2020
File name
UKIE_nplate_approved_SPC recon kit_v66.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.pdf
Reasons for updating
- New PIL for new product
Amgen Ireland Ltd
Address:
21 Northwood Court, Santry, Dublin D09 TX31, Ireland, 216 Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0WA, UKMedical Information E-mail:
gbinfoline@amgen.comTelephone:
+44 (0)1223 420 305Website:
https://www.amgen.co.ukMedical Information Direct Line:
+44 (0)1223 436 441/Freephone: 1800 535160Customer Care direct line:
+44 (0)1223 436441/Freephone: 1800 535160