Zykadia 150 mg 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 04 March 2022
File name
Zykadia_150mg_REG PIL_PF22-0049_Hard Capsules_150mg_16-Feb-22_English_Clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 04 March 2022
File name
Zykadia 150mg Capsules REG SPC PF22-0049 Feb 2022_clean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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 4.8 - Undesirable effects
- 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)
Updated on 04 May 2021
File name
Zykadia 150mg Capsules REG PIL PF21-095 TBI 06 Feb 2022_IPHA.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
Removal of black triangle and addition of sodium-free statement
Updated on 29 April 2021
File name
Zykadia 150mg Capsules REG SPC PF21-095 March 2021_IPHA.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 5.1 - Pharmacodynamic properties
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Black triangle removed. Addition of sodium statement. Update text re gastrointestinal adverse reactions in Sections 4.2 and 4.8. Update trial data for Ascend 8 (A2112) study.
Updated on 30 January 2020
File name
Zykadia 150mg Capsules PIL PF20-016 IPHA.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 30 January 2020
File name
Zykadia 150mg Capsules REG SPC PF 20-016 January 2020 clean IPHA.pdf
Reasons for updating
- 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
Shelf-life increased from 2 years to 3 years
Updated on 10 April 2019
File name
Zykadia 150mg Capsules REG PIL PF18-096 TBI 06 September 2019 IPHA.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
Updated on 10 April 2019
File name
Zykadia_150mg Capsules REG SPC PF18-096 April 2019 clean IPHA.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Minor editorial changes to Sections 4.2, 6.1 and 6.5.
Updated on 21 March 2019
File name
Zykadia_150mg Capsules REG PIL PF18-256 TBI 12 September 2019 IPHA.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 21 March 2019
File name
Zykadia_150mg Capsules REG SPC PF18-256 IPHA.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Revision of recommendations for concomitant use of Zykadia with CYP3A and CYP2C9 substrates based on A2103 drug interaction study results.
Changes to the list of examples of CYP3A substrates with narrow therapeutic index (NTI) {addition of alfuzosin, amiodarone, dihydroergotamine, quetiapine, lovastatin, simvastatin, sildenafil, midazolam, triazolam and deletion of astemizole}
Updated on 04 September 2018
File name
Zykadia REG PIL 2214854 PF18-152 TBI 30 March 2019 IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 26 July 2018
File name
Zykadia_150mg Capsules REG SPC PF17-082 clean IPHA.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 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Zykadia REG PIL 2212401 PF17-028_TBI 19 October 2018 IPHA.pdf
Updated on 23 May 2018
File name
Zykadia150mgCapsulesREGSPCPF17-028clean.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 September 2015
File name
PIL_16363_58.pdf
Reasons for updating
- New PIL for new product
Updated on 16 September 2015
Reasons for updating
- Change to side-effects
Updated on 03 September 2015
Reasons for updating
- Introduction of new pack/pack size
Updated on 10 June 2015
Reasons for updating
- New PIL for new product