VELETRI 1.5 mg, Powder for Solution for Infusion

  • Name:

    VELETRI 1.5 mg, Powder for Solution for Infusion

  • Company:
    info
  • Active Ingredients:

    Epoprostenol Sodium

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/05/20

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Summary of Product Characteristics last updated on medicines.ie: 13/5/2020

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Janssen-Cilag International NV

Company Products

Medicine NameActive Ingredients
Medicine Name VELETRI 0.5 mg, Powder for Solution for Infusion Active Ingredients Epoprostenol Sodium
Medicine Name VELETRI 1.5 mg, Powder for Solution for Infusion Active Ingredients Epoprostenol Sodium
1 - 0 of 2 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 16 May 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

change to batch release site

Updated on 13 May 2020 SmPC

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Updated inline with QRD template and/or excipient guideline

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

Free text change information supplied by the pharmaceutical company

Editorial changes and addition of date of license renewal.

Updated on 13 May 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Change to batch release site

Updated on 3 April 2020 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Correction to marketing authorisation number.

Updated on 21 February 2020 SmPC

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Addition of new pump information CADD Solis VIP.

Updated on 21 February 2020 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

Addition of new pump information CADD Solis VIP.

Updated on 30 October 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 30 October 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 19 September 2019 SmPC

Reasons for updating

  • File format updated to PDF

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

Updated on 19 September 2019 PIL

Reasons for updating

  • XPIL Updated

Updated on 21 November 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 5 June 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)

Free text change information supplied by the pharmaceutical company

Cardiac Disorders: High output cardiac failure (Unknown)

Updated on 21 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 21 February 2018 SmPC

Reasons for updating

  • 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

DATE OF REVISION OF THE TEXT

Updated on 21 February 2018 PIL

Reasons for updating

  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

DATE OF REVISION OF THE TEXT

Updated on 20 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 June 2017 PIL

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided

Updated on 1 June 2017 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided