Nubeqa 300 mg film-coated tablets
*Company:
Bayer LimitedStatus:
No Recent UpdateLegal 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
 - Carton-Blister Image Angle 1 View 2 English_1647018092.png)
Updated on 28 May 2024
File name
20240527_SmPC_CC_NUB_REC31524PSUSA7.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
4.4 Special warnings and precautions for use
Hepatotoxicity
In case of liver function test abnormalities suggestive of idiosyncratic drug‑induced liver injury, permanently discontinue treatment with darolutamide (see section 4.8).
4.8 Undesirable effects
Description of selected adverse reactions
Liver function tests
Updated on 06 March 2023
File name
20230301_SmPC_CC_NUB_Arasens.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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 06 March 2023
File name
20230301_PIL_CC_NUB_Arasens.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Updated on 28 February 2023
File name
20230228_SmPC_CC_NUB_REC30977.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 19 January 2023
File name
20211209_SmPC_CC_NUB_REC15506.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Reuploaded
Updated on 11 March 2022
File name
20211209_PL_CC_NUB_REC15506.pdf
Reasons for updating
- New PIL for new product
Updated on 11 March 2022
File name
20211209_SmPC_CC_NUB_REC15506.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
Upload to coincide with launch