Mysimba 8 mg/90 mg prolonged-release tablets
*Company:
Consilient Health LtdStatus:
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
File name
PPC MYSIMBA IE.pdf
Reasons for updating
- New EDM File
Updated on 18 June 2024
File name
ie - PIL -en.pdf
Reasons for updating
- Change to other sources of information section
Updated on 10 July 2023
File name
ie-spc-07.07.2023.pdf
Reasons for updating
- 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)
Updated on 10 July 2023
File name
ie-pil-0.7.07.2023.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 17 March 2023
File name
ie-spc-IB062-mar23.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 March 2023
File name
ie-pil-IB062-mar23.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 28 June 2022
File name
ie-pil-h-3687_28_Jun_2022.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 28 June 2022
File name
ie-spc-h-3687_28_Jun_2022.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 10 May 2022
File name
ie-pil-h-3687_26_Apr_2022.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 10 May 2022
File name
ie-spc-h-3687_26_Apr_2022.pdf
Reasons for updating
- 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)
Updated on 22 June 2021
File name
ie-pil-h-3687-17_Jun_2021.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 22 June 2021
File name
ie-spc-h-3687_17_Jun_2021.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 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 January 2021
File name
ie-spc-h-3687_26_Nov_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 - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 January 2021
File name
ie-pil-h-3687-26_Nov_2020.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Removal/change of distributor
Updated on 06 August 2020
File name
ie-pil-h-3687_PBRER_PSUR_7_july 2020.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Free text change information supplied by the pharmaceutical company
To align the PIL text with the current SmPC, which states that naltrexone/bupropion should not be used during pregnancy or in women currently attempting to become pregnant
Updated on 06 August 2020
File name
ie-spc-h-3687_PBRER_PSUR_7_july 2020.pdf
Reasons for updating
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Formatting change to the SmPC only
Updated on 07 November 2019
File name
IE SPC-h3687-en - 07Nov19 II 0029G.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
to update section 4.8 on the list of adverse drug reactions and their corresponding frequencies following the PRAC outcome on PSUR procedure (PSUSA/10366/201709).
to update sections 4.2, 4.4 and 5.2 of the SmPC to reflect the results from a study to evaluate the pharmacokinetics of a single oral dose of extended-release combination of naltrexone and bupropion in subjects with normal hepatic function or varying degrees of impaired hepatic function.
Updated on 07 November 2019
File name
IE PIL-h3687-en - 07Nov19 II 0029G.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Following approval of a Type II variation, the adverse drug reactions and their corresponding frequencies have been updated.
Updated on 04 June 2019
File name
Mysimba_PIL_29-Mar-19.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 18 September 2018
File name
ema-combined-h3687en - pil ie.pdf
Reasons for updating
- Change of distributor details
Updated on 17 September 2018
File name
ema-combined-h3687en - smpc - ie.pdf
Reasons for updating
- 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
Sep 18 - Addition of Urticaria as an Uncommon side effect.
Updated on 23 April 2018
File name
ema-combined-h3687en-annotated.pdf
Reasons for updating
- New PIL for new product
Updated on 13 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 February 2018
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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
Updated on 13 February 2018
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
Free text change information supplied by the pharmaceutical company
Updated on 20 November 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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
Updated on 20 November 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
Updated on 29 June 2017
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
Updated on 29 June 2017
Reasons for updating
- New SPC for new product