Rapamune 0.5mg, 1mg and 2mg coated tablets

  • Name:

    Rapamune 0.5mg, 1mg and 2mg coated tablets

  • Company:
    info
  • Active Ingredients:

    Sirolimus

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/06/19

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Summary of Product Characteristics last updated on medicines.ie: 21/6/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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1 - 0 of 230 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 21 June 2019 PIL

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 21 June 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.2 - Incompatibilities

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Correction of the amount of ethanol for the oral solution and update to the ammonium hydroxide information in Sections 2 and 6.2, repositioning of the sentence in Section 4.2 that treatment should be initiated by and remain under the guidance of an appropriately qualified specialist in transplantation, and minor correction regarding the excipient concentrated ammonium solution in section 6.2

Updated on 23 October 2018 PIL

Reasons for updating

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

Updated on 22 October 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows.

SPC section 7: Marketing authorisation holder change to Pfizer EEIG.

Updated on 3 October 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 3 October 2018 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 6.3 – Shelf life.

Updated on 14 August 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 9 August 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section

Section 4.1 Indication. – New indication for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function

Section 2 Posology patients with sporadic lymphangioleiomyomatosis

Section 4.4 clarification on warnings relating to only renal transplant patients

Section 4.8 Clarification on undesirable effects observed with prophylaxis of organ rejection in renal transplantation

Section 4.8 Undesirable effects observed with patients with S-LAM

Section 5..1 and 5.2 Clinical data on treatment of sporadic lymphangioleiomyomatosis

Updated on 8 August 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 8 August 2018 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section

Section 4.8 AE reporting details for UK.

Updated on 5 June 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 2, 3, 4.2, 4.4, 4.8, 5.2, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, and 8.

Updated on 27 March 2017 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 27 March 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 23 October 2015 PIL

Reasons for updating

  • Change of inactive ingredient

Updated on 26 June 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details

Updated on 1 April 2015 PIL

Reasons for updating

  • PIL re-instated

Updated on 23 March 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of manufacturer

Updated on 5 August 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 2 August 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 21 January 2013 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision
  • Change to MA holder contact details

Updated on 4 August 2011 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 8 April 2011 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 1 February 2011 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 19 January 2011 PIL

Reasons for updating

  • New PIL for medicines.ie