NINLARO 2.3 mg, 3 mg, 4 mg hard capsules
- Name:
NINLARO 2.3 mg, 3 mg, 4 mg hard capsules
- Company:
Takeda Products Ireland Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/09/20
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Takeda Products Ireland Ltd
Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 25 November 2020 SPC
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 SPC
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 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 11 September 2020 PIL
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 SPC
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 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 25 September 2019 SPC
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 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 28 September 2018 SPC
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 9 October 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 9 October 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 9 October 2017 SPC
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 9 October 2017 PIL
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 SPC
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 4 January 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 4 January 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)