Nplate reconstitution kit
*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_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