Tepkinly 48 mg solution for injection
*Company:
AbbVie LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 22 December 2024
File name
Tepkinly_PIL_48mg_PSUR_Dec24.pdf
Reasons for updating
- Change to side-effects
Free text change information supplied by the pharmaceutical company
Update to section 2 relating to side effects of Tepkinly.
Updated on 22 December 2024
File name
Tepkinly_SmPC_48mg_PSUR_Dec24.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 December 2024
File name
Tepkinly_SmPC_48mg_FL_Aug24.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update typographic error
Updated on 21 August 2024
File name
Tepkinly_SmPC_48mg_FL_Aug24.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to the PIL following the addition of follicular lymphoma.
Updated on 21 August 2024
File name
Tepkinly_PIL_48mg_FL_Aug24.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Update to the PIL following the addition of follicular lymphoma.
Updated on 15 April 2024
File name
Tepkinly_PIL_48mg_ePI_April 2024.pdf
Reasons for updating
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Other sources of information - update to include URL: www.tepkinly.eu and the relevant QRD code.
File name
12842_Tepkinly_Card_SEPT23_LR6.pdf
Reasons for updating
- Add New Doc
File name
12842_Tepkinly_Card_SEPT23_LR6.pdf
Reasons for updating
- Add New Doc
Updated on 09 November 2023
File name
Tepkinly_SmPC_48mg_MAA_Sept 23.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New product registration
Updated on 09 November 2023
File name
Tepkinly_PIL_48mg_MAA_Sept 23.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New product registration