NINLARO 2.3 mg, 3 mg, 4 mg hard capsules
*Company:
Takeda Products Ireland LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 26 March 2024
File name
ie-smpc-ninlaro-clean-2024.03.21.pdf
Reasons for updating
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 March 2024
File name
ie-leaflet-ninlaro-clean-2024.03.21.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 10 November 2023
File name
ie-smpc-ninlaro-clean-SOB004-conversion to full MA-06.11.23.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
- Change to MA holder contact details
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 November 2023
File name
ie-leaflet-ninlaro-clean-SOB004-conversion to full MA-06.11.23.pdf
Reasons for updating
- Removal of Black Inverted Triangle
- Change to improve clarity and readability
- Change to date of revision
Updated on 18 September 2023
File name
Ninlaro SmPC IE-clean-renewal-2023.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 30 September 2022
File name
Ninlaro SmPC Ireland 13.09.2022.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 December 2021
File name
Ninlaro PIL Ireland 02.09.2021.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 08 December 2021
File name
Ninlaro SmPC Ireland 02.09.2021.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 Addition on Stevens-Johnson syndrom in the cutaenous reactions section
Updated on 16 November 2021
File name
Ninlaro PIL IE 12.11.2021.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 16 November 2021
File name
Ninlaro SmPC IE 12.11.2021.pdf
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 Undesirable effects:
Percentage figures of adverse reactions amended in the descriptive text for the pooled safety data, and in the description of selected adverse reactions section.
Tabulated list of adverse reactions updated with the addition of bronchitis as a very common (all grades) and a common grade 3; upper respiratory tract infection updated to common grade 3; constipation moved up the table to come under diarrhoea.
Section 5.1 Pharmacodynamic properties:
PFS results added for patients with 1 and 2-3 prior therapies.
Final overall survival data added.
Updated on 27 May 2021
File name
Ninlaro SmPC IE 12.04.2021.pdf
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 5.1 ATC code has been amended from L01XX50 to L01XG03
Updated on 27 May 2021
File name
Ninlaro PIL IE 12.04.2021.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
Ninlaro SmPC IRE 21.01.2021.pdf
Reasons for updating
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 January 2021
File name
Ninlaro PIL IRE 21.01.2021.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 25 November 2020
File name
Ninlaro SmPC IRE 12.11.2020.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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Re-location of the following rare adverse drug reactions from the text portion in section 4.8 under ‘Other adverse reactions’ into the adverse reactions Table 3:- Tumor lysis syndrome, Posterior reversible encephalopathy disorders, Transverse myelitis, Stevens-Johnson syndrome, Acute febrile neutrophilic dermatosis. The dagger symbol (which represents being reported outside of the phase 3 studies) does not apply to acute febrile neutrophilic dermatosis.
Updated on 29 September 2020
File name
Ninlaro SmPC IRE 28.08.2020.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 7 updated with new marketing authorisation holder address
Updated on 29 September 2020
File name
Ninlaro PIL IRE 28.08.2020.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 11 September 2020
File name
Ninlaro PIL IRE 25.08.2020.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 11 September 2020
File name
Ninlaro SmPC IRELAND 25.08.2020.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of Thrombotic microangiopathy subheading to to section 4.4 (Special warnings and precautions for use)
Addition of Thrombotic microangiopathy and Thrombotic thrombocytopenic purpura to adverse reaction table 3 in Section 4.8 (Undesirable effects)
Removal of address and telephone number from section 4.8 Reporting of suspected adverse reactions
Date of revision of text amended to 25 August 2020
Updated on 25 September 2019
File name
Ninlaro PIL IRE 16.09.2019.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 25 September 2019
File name
Ninlaro SmPC IRE 16.09.2019.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SmPC and labels – not affected
PIL –
- section 6 – addition of Takeda Ireland Limited Grange Castle address.
- Section 6 – date of revision
Updated on 28 September 2018
File name
Ninlaro PIL UK+IRE 17.09.2018.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 28 September 2018
File name
Ninlaro SmPC IRE 17.09.2018.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- Marketing authorisation renewal
- Change of the word Ninlaro to Ixazomib throughout the SmPC document
- Update to revision date of SmPC
Updated on 09 October 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 October 2017
File name
PIL_17030_561.pdf
Reasons for updating
- New PIL for new product
Updated on 09 October 2017
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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Change to section |
Details of change |
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10. DATE OF THE REVISION OF THE TEXT |
18 September 2017 |
Other formating changes also included
Updated on 09 October 2017
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
Updated on 20 July 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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Change to section |
Details of change |
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4.8 Undesirable effects
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Inclusion of pooled safety data from the pivotal, Phase 3, global C16010 study (n=720) and the double-blind, placebo-controlled C16010 China Continuation Study (n=115).
AND
The frequency of the following adverse reactions has been reclassified: Herpes zoster – common (≥ 1/100 to < 1/10) Vomiting - uncommon (≥ 1/1,000 to < 1/100).
Updates to the paragraphs relating to thrombocytopenia, rash, peripheral neuropathy, eye disorders, other adverse reactions. |
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5.1 Pharmacodynamic properties
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A randomized, double-blind, placebo-controlled Phase 3 study was conducted in China (N=115) with a similar study design and eligibility criteria. Many of the patients enrolled in the study had advanced disease with Durie-Salmon Stage III (69%) at initial diagnosis and a treatment history of receiving at least 2 prior therapies (60%) and being thalidomide refractory (63%). At the primary analysis (median follow up of 8 months and a median of 6 cycles), the median PFS was 6.7 months in the NINLARO regimen compared to 4 months in the placebo regimen (p-value=0.035, HR=0.60). At the final analysis for OS at a median follow up of 19.8 months,
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10. DATE OF REVISION OF THE TEXT
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6 July 2017
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Updated on 04 January 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 04 January 2017
Reasons for updating
- New PIL for new product