IVEMEND 150 mg powder for solution for infusion * Pharmacy Only: Prescription
Company:
MSD Ireland (Human Health) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 14 February 2023
File name
63eb98df6798f.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC document format updated to html.
Updated on 31 August 2022
File name
630f193897617.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Addition of United Kingdom (Northern Ireland) details – details on how to report side effects from UK(NI) and local representative contact details for UK(NI) are added.
Updated on 22 November 2021
File name
IVEMEND-H-C-0743-II-045-SPC-IE-PI_Sep2021_1637579765.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of first authorisation/renewal of the 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
- Update of section 4.8 of the SPC with the final results from study P045; a non-randomised, single-group, multi-site, open-label study to evaluate the safety and tolerability of consecutive 3-day intravenous fosaprepitant in paediatric participants scheduled to receive a moderately or highly emetogenic chemotherapy agent/regimen or a chemotherapy agent/regimen not previously tolerated due to vomiting.
- Update section 9 of the SPC to correct the date of the latest renewal.
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. |
Merck Sharp & Dohme B.V. |
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
File name
PIL_14894_956.pdf
Reasons for updating
- New PIL for new product
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
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
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
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
Updated on 07 February 2011
Reasons for updating
- New PIL for new product