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Kyleena 19.5 mg intrauterine delivery system

  • Name:

    Kyleena 19.5 mg intrauterine delivery system

  • Company:
    info
  • Active Ingredients:

    Levonorgestrel

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/06/19

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Summary of Product Characteristics last updated on medicines.ie: 19/6/2019

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Bayer Limited

Bayer Limited

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1 - 0 of 69 items.Total: Infinity pages

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 20 June 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 19 June 2019 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to warnings and prcautions due to PRAC reccommendation

Updated on 10 December 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 10 December 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 1 August 2018 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 17 May 2018 SmPC

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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

The SmPC has updated as a result of the final study report for the subgroup of EURAS-IUD. The perforation text under subsection ‘Insertion and removal/ replacement’ was adapted to current medical practice, the average estimated in vivo release rate over the 1st year was added to section 5.2 and text under 4.8 regarding sepsis was adjusted to reflect the class effect. Editorial spelling changes also made.

Updated on 26 April 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 4 April 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 4 April 2018 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 6.3, the shelf-life has been changed from 2 to 3 years.

In section 10, the revision date has been updated to March 2018.

Updated on 4 April 2017 SmPC

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

None provided

Updated on 4 April 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 3 April 2017 PIL

Reasons for updating

  • New PIL for new product