Pelmeg 6 mg solution for injection in pre-filled syringe

  • Name:

    Pelmeg 6 mg solution for injection in pre-filled syringe

  • Company:
    info
  • Active Ingredients:

    Pegfilgrastim

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/11/19

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Summary of Product Characteristics last updated on medicines.ie: 25/11/2019
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.

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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

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1 - 0 of 31 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 25 November 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Addition of Stevens-Johnson syndrome to section 4.4 and section 4.8.

Updated on 25 November 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Addition of Stevens-Johnson syndrome to section 2 'Warnings and precautions' and section 4 'Possible side effects'.

Updated on 6 September 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Free text change information supplied by the pharmaceutical company

Change of marketing authorisation holder and addition of date of first authorisation.

Updated on 6 September 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 5 February 2019 PIL

Reasons for updating

  • Addition of Black Inverted Triangle

Updated on 4 February 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 February 2019 SmPC

Reasons for updating

  • New SmPC for new product

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