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Lysopadol 17.86 mg/ml Oromucosal Spray

  • Name:

    Lysopadol 17.86 mg/ml Oromucosal Spray

  • Company:
    info
  • Active Ingredients:

    Ambroxol hydrochloride

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/08/18

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Summary of Product Characteristics last updated on medicines.ie: 10/8/2018

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SANOFI

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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 28 August 2018 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 10 August 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to product name

Updated on 10 August 2018 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

5.1       Pharmacodynamic properties - updated Pharmacotherapeutic group ATC code from R02AD05 to R02AD.

9.         DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

                            Date of last renewal updated to 17th January 2019

10.       DATE OF REVISION  Updated to July 2018

Updated on 15 August 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 15 August 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7 (Marketing Authorisation Holder) has been amended.  Boehringer Ingelheim Limited details have been replaced by sanofi-aventis Ireland Ltd details.

Section 8 (Marketing Authorisation Number) has been amended.  PA 7/63/2 has been replaced by PA 540/186/2.

Section 10 (Date of Revision of the Text) has been amended from June 2016 to August 2017.

Updated on 15 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 15 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 July 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 July 2016 SmPC

Reasons for updating

  • New SPC for new product
  • New SPC for medicines.ie

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided