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 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 - Prep Mat.pdf
Reasons for updating
- Add New Doc
File name
HAT pack - DVD label.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