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 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