MUSE 500 microgram urethral stick.

  • Name:

    MUSE 500 microgram urethral stick.

  • Company:
    info
  • Active Ingredients:

    Alprostadil

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/02/19

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Summary of Product Characteristics last updated on medicines.ie: 19/2/2019

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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1 - 0 of 95 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 19 February 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 February 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 20 February 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 20 February 2018 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • 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

$0In section 3: Changeto excipient name from Macrogol to Polyethylene glycol$0$0In section 4.1:Therapeutic indications have changed, 'Muse is indicated in adults aged 18years and above'.$0$0In section 4.8:Reporting obligations have been updated from IMB to HPRA$0$0In section 6.1:Change to the list of excipients- Macrogol to Polyethlene Glycol$0$0In section 10: Thedate of revision has been updated$0

Updated on 20 February 2018 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

$0In section 3: Changeto excipient name from Macrogol to Polyethylene glycol$0$0In section 4.1:Therapeutic indications have changed, 'Muse is indicated in adults aged 18years and above'.$0$0In section 4.8:Reporting obligations have been updated from IMB to HPRA$0$0In section 6.1:Change to the list of excipients- Macrogol to Polyethlene Glycol$0$0In section 10: Thedate of revision has been updated$0

Updated on 29 May 2014 PIL

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.6: The title has been expanded to include fertility as per requirements to adapt to the QRD template.

In section 4.8: Information on how to report adverse reactions to the IMB has been added

In section 10: the date of revision has changed.

Updated on 29 May 2014 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.6: The title has been expanded to include fertility as per requirements to adapt to the QRD template.

In section 4.8: Information on how to report adverse reactions to the IMB has been added

In section 10: the date of revision has changed.

Updated on 27 November 2012 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.2: the starting dose has been increased from 250mcg to 500mcg

In section 10: the date of revision has been changed to November 2012

Updated on 27 November 2012 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.2: the starting dose has been increased from 250mcg to 500mcg

In section 10: the date of revision has been changed to November 2012

Updated on 14 December 2011 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 7; address of MA changed
in section 10; date of revision changed

Updated on 14 December 2011 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

In section 7; address of MA changed
in section 10; date of revision changed

Updated on 10 January 2008 PIL

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

 

Section 9: Date of renewal changed to 10 October 2007

Section 10: changed to December 2007

Updated on 10 January 2008 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • 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

 

Section 9: Date of renewal changed to 10 October 2007

Section 10: changed to December 2007

Updated on 2 October 2007 PIL

Reasons for updating

  • New SPC for medicines.ie

Updated on 2 October 2007 SmPC

Reasons for updating

  • New SPC for medicines.ie

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