Sialanar 320 micrograms/ml Glycopyrronium (400 micrograms/ml Glycopyrronium Bromide) Oral Solution

  • Name:

    Sialanar 320 micrograms/ml Glycopyrronium (400 micrograms/ml Glycopyrronium Bromide) Oral Solution

  • Company:
    info
  • Active Ingredients:

    Glycopyrronium bromide, Glycopyrrolate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/10/19

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Summary of Product Characteristics last updated on medicines.ie: 28/7/2020

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Proveca Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Sialanar 320 micrograms/ml Glycopyrronium (400 micrograms/ml Glycopyrronium Bromide) Oral Solution Active Ingredients Glycopyrronium bromide, Glycopyrrolate
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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 July 2020 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to Tables 1 and 2

Updated on 9 October 2019 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 9 October 2019 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 12 April 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 12 April 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 31 January 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 31 January 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 2, the content of sodium benzoate has been added.

In section 4.4, sodium benzoate has been added.

In section 6.5, reference to the new 60 ml bottle has been added (in addition to the 250 ml) and the statement "Not all pack sizes may be marketed" included.

In section 8, the marketing authorisation number for the new 60 ml bottle presentation has been added. 

In section 10, the data of the revision of the text has been updated.

Updated on 28 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 11 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 26 April 2018 PIL

Reasons for updating

  • New PIL for new product