Kyntheum 210 mg Solution for Injection

  • Name:

    Kyntheum 210 mg Solution for Injection

  • Company:
    info
  • Active Ingredients:

    Brodalumab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/11/18

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Summary of Product Characteristics last updated on medicines.ie: 25/9/2017
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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

LEO Pharma

LEO Pharma

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Medicine Name innohep 10,000 IU in 0.5 ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 10,000 IU/ml Solution for Injection (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 12,000 IU in 0.6ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 14,000 IU in 0.7 ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 16,000 IU in 0.8ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 18,000 IU in 0.9ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 2,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name Innohep 20,000 IU/ml Solution for Injection (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name innohep 3,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 4,500 IU syringe (Prophylaxis and Haemodialysis) Active Ingredients Tinzaparin sodium
Medicine Name innohep 8,000 IU in 0.4ml syringe (Treatment in VTE) Active Ingredients Tinzaparin sodium
Medicine Name Kyntheum 210 mg Solution for Injection Active Ingredients Brodalumab
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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 2 November 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 3 July 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 2 October 2017 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 2 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 September 2017 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 25 September 2017 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • 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 6.5 a new pack size, a multipack of three packs of two pre-filled syringes has been added. A statement that not all pack sizes may be marketed has been added.
- In Section 8 a new marketing authorisation number associated with the new pack size has been added.
- In Section 10 the date of revision has been updated.

Updated on 25 September 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 21 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 July 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