Tepkinly 4 mg/0.8 ml 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_4mg-0.8ml_PSUR_Dec24.pdf
Reasons for updating
- Change to side-effects
Free text change information supplied by the pharmaceutical company
Update to section 2 of the PIL relating to side effects.
Updated on 22 December 2024
File name
Tepkinly_SmPC_4mg-0.8ml_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_4mg-0.8ml_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_4mg-0.8ml_FL_Aug24.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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_4mg-0.8ml_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
- Change to section 6 - date of revision
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_4mg-0.8ml_ePI_April 24.pdf
Reasons for updating
- Addition of information on alternative format leaflets
Free text change information supplied by the pharmaceutical company
Other sources of Information - updated to include the URL: www.tepkinly.eu and the relevant QRD code.
Updated on 09 November 2023
File name
Tepkinly_SmPC_4mg-0.8ml_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_SmPC_4mg-0.8ml_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_4mg-0.8ml_MAA_Sept 23.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New product registration.
File name
12842_Tepkinly_Card_SEPT23_LR6.pdf
Reasons for updating
- Add New Doc