MYLOTARG 5mg powder for concentrate for solution for infusion
*Company:
Pfizer Healthcare IrelandStatus:
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 08 November 2023
File name
Adv SPC ML 10 0 IE clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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)
Updated on 17 November 2022
File name
AdvSPCML90IEclean (2).pdf
Reasons for updating
- Correction of spelling/typing errors
- Removal of Black Inverted Triangle
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: removal of black triangle and editorial updates.
Updated on 17 November 2022
File name
ADVPILML100IENIclean (2).pdf
Reasons for updating
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
- Correction of spelling/typing errors
Updated on 21 July 2022
File name
ADV PIL ML 9_0 IE NI clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 21 July 2022
File name
Adv SPC ML 8_0 IE clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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)
Updated on 22 June 2022
File name
AdvSPCML70IEclean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 April 2022
File name
ADVPILML80IENIclean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 08 October 2021
File name
ADV PIL ML 7_0 IE & NI clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to MA holder contact details
Updated on 17 November 2020
File name
DEC202076369_ADV SPC ML 6_0 IE Clean.pdf
Reasons for updating
- 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 5.3 - Preclinical safety data
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 November 2020
File name
DEC202076369_ADV PIL ML 6_0 IE Clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - manufacturer
- Change to other sources of information section
- Change to information for healthcare professionals
Updated on 30 April 2020
File name
DEC202027855_ADV PIL ML 5_0 UK IE CLEAN.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 25 October 2019
File name
DEC201958890_ADV SPC ML 5_0 UK IE_clean.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 5.2 - Pharmacokinetic properties
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Text amended throughout according to QRD 10..
Updated on 25 October 2019
File name
DEC201958890_ADV PIL ML 4_0 UK IE_clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to other sources of information section
- Change to information for healthcare professionals
Updated on 16 October 2019
File name
DEC201953275_ADV SPC ML 4_0 UK IE-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
The SPC has been updated as follows: Sections 4.8 and 5.1 updated to include information for paediatric refractory/relapsed AML.
Updated on 12 December 2018
File name
ADV PIL ML 3_0 UK IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 12 December 2018
File name
ADV SPC ML 3_0 UK IE clean.pdf
Reasons for updating
- 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
The SPC has been updated as follows: revision date only following change to annex A
Updated on 20 August 2018
File name
ADV PIL ML 2_0 UK IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 03 August 2018
File name
ADV SPC ML 2_0 UK IE clean.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
The SPC has been updated as follows:
Section 7 – Change to MAH
Section 10 – Date of revision of text
Updated on 04 May 2018
File name
ADV_SPC_ML_1_0_UK_IE.docx
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
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Product to be launched TBC actual date TBC ASAP, I will send an update when I have this date and please note PEARL will be updated on the launch date. |
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SPC: |
New SPC to reflect the new Pfizer Marketing Authorisation |
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PIL: |
New PIL to reflect the new Pfizer Marketing Authorisation |
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Packaging: |
New packaging to reflect the new Pfizer Marketing Authorisation |
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PI: |
New PI to reflect the new Pfizer Marketing Authorisation |
Updated on 26 April 2018
File name
ADV PIL ML 1_0 UK IE.pdf
Reasons for updating
- New PIL for new product