IVEMEND 150 mg powder for solution for infusion *

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 03 June 2020

File name

IVEMEND-H-C-0743-IB-042-PI-SPC-en-CRT-April-2020 (002).pdf_1591189460.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

Updated in-line with QRD template and/or excipient guideline

 

Updated on 03 June 2020

File name

QRD-PIL-IVEMEND-H-C-0743-IB-042-PI-en-CRT.pdf_1591189221.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 06 February 2019

File name

NK Local-IVEMEND-H-C-0743-II-040-PI-en-CRT_1549453415.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 06 February 2019

File name

IVEMEND-H-C-0743-II-040-SPC-en-CRT November 2018_1549467847.pdf

Reasons for updating

  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Change to section 4.4: update the safety information related to Infusion Site Reactions (ISR) based on reports of post-marketing experience; Change to section 4.2, 4.8, 5.1, 5.2, 10: editorial changes

 

Updated on 06 February 2019

File name

NK IVEMEND-H-C-0743-II-040-SPC-en-CRT November 2018_1549467431.

Reasons for updating

  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Change to section 4.4: update the safety information related to Infusion Site Reactions (ISR) based on reports of post-marketing experience; Change to section 4.2, 4.8, 5.1, 5.2, 10: editorial changes

 

Updated on 06 February 2019

File name

NK IVEMEND-H-C-0743-II-040-SPC-en-CRT_1549459319.pdf

Reasons for updating

  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Change to section 4.4: update the safety information related to Infusion Site Reactions (ISR) based on reports of post-marketing experience; Change to section 4.2, 4.8, 5.1, 5.2, 10: editorial changes.

 

Updated on 13 August 2018

File name

IVEMEND-H-C-0743-T-039-PIL-IE-en-CRT (2)_1534153870.pdf

Reasons for updating

  • 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 13 August 2018

File name

SPC_IVEMEND-H-C-0743-T-039-PI-en-CRT (2)_1534154106.pdf

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

Change to section 7:

Present

Proposed

Merck Sharp & Dohme Ltd.
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

Updated on 21 May 2018

File name

IVEMEND-H-C-0743-II-0037-SPC-en-CRT.docx

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Change to section 4.1; 4.2, 4.5; 4.8; 5.1, 5.2,   (indication for paediatric population);

Updated on 18 May 2018

File name

QRD_PIL-IVEMEND_II-037 (2).pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 27 January 2017

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

SPC change details: Change to section 4.2, 5.1, 5.2,   (paediatric population); Change to section 4.4, 4.8  (anaphylaxis/anaphylactic shock); Change to section 5.3 (Preclinical data)

Updated on 27 January 2017

Reasons for updating

  • New SPC for new product

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

Updated on 27 January 2017

File name

PIL_14894_956.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 January 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 05 September 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Additional clinical study data in sections 4.8, 5.1

Updated on 01 September 2016

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 17 October 2014

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 07 March 2014

Reasons for updating

  • Change to drug interactions
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 15 January 2014

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.4 - Special precautions for storage
  • 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

Which SPC sections have changed: 4.5, 4.8, 6.4, 10 
Detailed SPC change information: Updated Post-marketing events (neurotoxicity with aprepitant and ifosfamide); added details for reporting suspected adverse reactions; updated storage condition wording

Updated on 27 August 2013

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 10 May 2013

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 26 April 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Updates to Sections: 4.2, 5.1,10

Updated on 18 December 2012

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision
  • PIL Product/presentation withdrawn

Updated on 07 December 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Updated posology; removal of reference to 115mg strength; updated pharmacokinetics

Updated on 28 February 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 12 January 2012

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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

Section 4.3, 4.4, 4.6, 4.7, 4.8 -

Updated side effects

Updated on 05 October 2011

Reasons for updating

  • Change to side-effects

Updated on 04 July 2011

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

Section 4.8 -

Updated side effects

Updated on 10 February 2011

Reasons for updating

  • New SPC 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

None provided

Updated on 07 February 2011

Reasons for updating

  • New PIL for new product