Tasigna 150mg and 200mg Hard Capsules
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 05 July 2023
File name
Tasigna 50 mg, 150 mg and 200 mg hard capsules_REGPIL BRS PF23-0044-clean IE only.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 18 July 2022
File name
Tasigna 50 mg, 150 mg and 200 mg hard capsules_PIL_PF22-0106 19.05.2022_clean_Lek_corrected 18.07.22_IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 20 June 2022
File name
Tasigna 50 mg, 150 mg and 200 mg hard capsules_PIL_PF22-0106 19.05.2022_clean_Lek.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 20 June 2022
File name
Tasigna Hard Caps_REG SPC_PF22_0106_19.05.2022_clean.pdf
Reasons for updating
- Addition of joint SPC covering all presentations
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 July 2021
File name
Tasigna 150mg Hard Caps_REG SPC_PF21-0174__24.06.2021_clean.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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 July 2021
File name
Tasigna 150mg -II-109 REGPIL PF21-0174_Clean_24.06.2021.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
Updated on 28 April 2021
File name
Tasigna 150mg Hard Caps_REG SPC_PF21-0096_11.03.2021_clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 November 2020
File name
Tasigna 150mg REGPIL PF20-0107 & PF20-0257__CleanOct 2020.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 25 November 2020
File name
Tasigna_150mg_ REGSPC_PF 20-0107 & PF 20-0257_English_Clean November 2020.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 October 2020
File name
Tasigna 150mg REGPIL PF 20-0098 March 2020 Clean IPHA.pdf
Reasons for updating
- Change of manufacturer
Updated on 26 November 2019
File name
Tasigna 150mg PIL November 2019 PF 19-0071_Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 26 November 2019
File name
Tasigna_150mg_HdCap REGSPC_PF 19-0071_Nov-19_Clean.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)
Updated on 06 September 2018
File name
Tasigna_150mg_hardcapsules_REGSmPC_PF18-0245_clean_IPHA.pdf
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 September 2018
File name
Tasigna 150mg_2211280_R91_p2_LFT_X-4_IPHA.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to marketing authorisation holder
Updated on 14 May 2018
File name
Tasigna_150mg_hardcapsules_REGSmPC_PF18-0075_Clean.docx
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 not be renewed (A)
Updated on 09 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 April 2018
File name
Tasigna 150mg_2206840_R91_p1_LFT_X-4_IPHA.pdf
Reasons for updating
- 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 2 - use in children and adolescents
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - marketing authorisation holder
Updated on 11 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 January 2018
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Typographical changes have been added to Sections 2 and 6.1
Updated on 21 July 2017
File name
PIL_15125_562.pdf
Reasons for updating
- New PIL for new product
Updated on 21 July 2017
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - duration of treatment
- Change to section 4 - possible side effects
Updated on 06 June 2017
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic 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
In section 4.2 Posology and method of administration, information has been added on Philadelphia chromosome positive CML patients in chronic phase who have been treated with Tasigna as first-line therapy and who achieved a sustained deep molecular response (MR4.5)
In section 4.4 Special warnings and precautions for use, information has been added on Eligibility for discontinuation of treatment & Monitoring of patients who have discontinued therapy
In section 4.6 Fertility, pregnancy and lactation addition information has been added on pregancy regarding treatment-free remission (TFR)
In Section 4.8 Undesirable effects information on Treatment discontinuation in Ph+ CML patients in chronic phase who have achieved a sustained deep molecular response has been added
In Section 5.1 Pharmacodynamic properties, information has been added on Treatment discontinuation in newly diagnosed Ph+ CML patients in chronic phase who have achieved a sustained deep molecular response
Section 6.6 Special precautions for disposal, has been updated
Updated on 22 June 2016
Reasons for updating
- Change to warnings or special precautions for use
Updated on 19 May 2016
Reasons for updating
- Change to warnings or special precautions for use
Updated on 13 May 2016
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
In Section 4.4 Special warnings and precautions for use, information has been added on Hepatitis B reactivation
In Section 4.8 Undesirable effects information has been added on Hepatitis B reactivation
Updated on 22 October 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.2 Posology and method of administration
Admin changes
5.1 Pharmacodynamic properties
Information has been added on MMR rate at 72 Months
Updated on 17 August 2015
Reasons for updating
- Introduction of new pack/pack size
Updated on 08 July 2015
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 June 2015
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 6.5 Nature and contents of container
New pack size added
Nature of blisters updated
Section 8. MARKETING AUTHORISATION NUMBER(S)
New number added
Updated on 22 April 2015
Reasons for updating
- Change to MA holder contact details
Updated on 10 December 2014
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 December 2014
Reasons for updating
- Change to side-effects
Updated on 06 August 2014
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.2 Posology and method of administration
Additional information has been added for Patients with cardiac disorders.
In Section 4.4 Special warnings and precautions for use
In Cardiovascular events data has been updated.
For Laboratory tests and monitoring of Blood lipids and Blood glucose data has been updated.
4.5 Interaction with other medicinal products and other forms of interaction
Information on nilotinib and CYP3A4 has been added.
Some typographical changes have been made.
4.8 Undesirable effects
Frequency of some side effects have changed, other side effects have been added of varying frequency.
Reporting of suspected adverse reactions details have been updated to include the new name for IMB (i.e. HPRA).
5.1 Pharmacodynamic properties
Data updated
5.2 Pharmacokinetic properties
Additional information has been provided on Elimination, Linearity/non-linearity and Bioavailability/bioequivalence studies
Updated on 17 June 2014
Reasons for updating
- Change to warnings or special precautions for use
Updated on 30 April 2014
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
In Section 4.4 Special warnings and precautions for use, information on Fluid retention and oedema and Cardiovascular events has been added.
In Section 4.8 Undesirable effects, “intermittent claudication” has been added as an uncommon vascular disorder.
Updated on 23 April 2014
Reasons for updating
- Change to warnings or special precautions for use
Updated on 24 January 2014
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 4.6 - Pregnancy and lactation
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.2 Posology and method of administration, the following has been inserted; Increases in blood glucose levels have been reported with Tasigna therapy (see section 4.4). Blood glucose levels should be assessed prior to initiating Tasigna therapy and as clinically indicated during treatment.
In Section 4.4 Special warnings and precautions for use; Information has been added on monitoring blood glucose levels.
In Section 4.6 Fertility, pregnancy and lactation; information on contracetive use has been extended to use highly effective contraception with Tasigna and for up to two weeks after ending treatment along with during treatment.
In Section 4.8 Undesirable effects, Elevated glucose and Elevated cholesterol (total) have been added to table Grade 3‑4 laboratory abnormalities and the Address in Appendix V has been updated.
Updated on 25 November 2013
Reasons for updating
- Change to warnings or special precautions for use
Updated on 02 September 2013
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 - 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
In Section 4.2 Posology and Method of administration the following information has been added
Increases in serum cholesterol levels have been reported with Tasigna therapy (see section 4.4). Lipid profiles should be assessed prior to initiating Tasigna therapy and as clinically indicated during treatment.
In Section 4.4 Special warnings and precautions for use the following information has been added:
Laboratory tests and monitoring; In a Phase III study in newly diagnosed CML patients, 1.1% of the patients treated with 400 mg nilotinib twice daily showed a Grade 3 4 elevation in cholesterol; no Grade 3 4 elevations were however observed in the 300 mg twice daily dose group. It is recommended that the lipid profile be assessed before initiating treatment with Tasigna and monitored during treatment, as clinically indicated (see section 4.2). If lipid-lowering agents are required, please refer to section 4.5 before initiating treatment since many cholesterol-lowering agents are also metabolised by the CYP3A4 pathway.
In Section 4.8 Undesirable effects the following information has been added:
Guidance on National Reporting of suspected adverse reactions as per Appendix V of the EMA requirements.
Updated on 02 July 2013
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.5 Interaction with other medicinal products and other forms of interaction; Typographical changes have been made.
In Section 4.8 Undesirable effects; The adverse reactions Alopecia and Dry skin have been changed from common to very common. The following common adverse reactions have also been added eosinophilia, hypertriglyceridaemia, dyslipidaemia, depression, angina pectoris, atrioventricular block, blood insulin increased, lipoprotein increased (including very low density and high density).
In Seaction 5.1 Pharmacodynamic properties; Information has been added on Major molecular response at 48 months.
Updated on 24 April 2013
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 23 April 2013
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 20 September 2012
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to dosage and administration
Updated on 30 August 2012
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 August 2011
Reasons for updating
- New PIL for medicines.ie
Updated on 16 May 2011
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)