Noxafil 300 mg concentrate for solution for infusion
*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 June 2023
File name
QRD-IE-NOXAFIL-conc for sol for inf-LFT-add Haarlem-062023.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 April 2023
File name
NOXAFIL-300mg conc for sol for Inf-H-C-0610-II077-SPC-IE-en-Feb2023.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Section 4.4 – editorial updates - underline 'Venetoclax toxicity'.
Section 5.1 & 5.2 – editorial corrections.
Section 10 – the last revision date.
Updated on 14 February 2023
File name
NOXAFIL 300mg conc for sol for inf-H-C-0610-X063G-II067-SPC-IE-en-Feb 2022.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 15 December 2022
File name
QRD-IE-Noxafil-conc for sol for inf-LFT-SNC_HEI-Nov2022.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Batch release site name change from 'Schering-Plough Labo nv' to 'Organon Heist bv’ (the legal entity name change only, the address remains the same).
Updated on 18 February 2022
File name
NOXAFIL 300mg conc for sol for inf-H-C-0610-X063G-II067-SPC-IE-en-Feb 2022.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- 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 5.3 - Preclinical safety data
- 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
Section 4.1 & 4.2 – Changes relate to dosing in paediatric indication.
Section 4.3, 4.4 & 4.5 – changes relates to interaction with venetoclax.
Section 4.8 – Changes relate to safety in paediatric population.
Section 5.1, 5.2 & 5.3 – changes relate to the paediatric population.
Section 10 – the last revision date.
Note: Number of editorial changes throughout the SPC have been made such as extra space deletions etc.
Updated on 18 February 2022
File name
QRD-IE-Noxafil-conc for sol for inf_LFT-X063G+II067_feb2022.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to section 1 - what the product is used for – Changes relate to paediatric indication.
Change to section 2 - what you need to know – contraindications - changes relates to interaction with venetoclax.
Change to section 2 - what you need to know - warnings and precautions - changes relates to interaction with venetoclax.
Change to section 2 - use in children and adolescents - change relates to paediatric indication.
Change to section 2 - interactions with other medicines, food or drink - changes relates to interaction with venetoclax.
Change to section 3 - how to take/use - change relates to paediatric indication.
Change to date of revision - The last revision date is updated.
Updated on 11 November 2021
File name
NOXAFIL 300mg-conc for sol for inf-H-C-0610-II-062-SPC-IE-en-Oct 2021.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.2 - Incompatibilities
- 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
Section 3 - Words ‘sterile concentrate’ have been added
Section 4.1 – The first line treatment for Invasive Aspergillosis
Section 4.2 – Recommended dose for treatment of Invasive Aspergillosis is added in table 1 and some editorial changes
Section 4.8 – Frequency of side effect ‘pseudoaldosteronism’ is updated from ‘not known’ to ‘rare’ and few paragraphs with overall information added above the table with the side effects.
Section 5.1 – New information added to microbiology, epidemiological Cut-off values for Aspergillus spp. and breakpoints subheadings. Also, information re clinical experience with posaconazole and Invasive Aspergillosis has been added.
Section 5.2 – New information about pharmacokinetics in special populations has been added, the paragraph re posaconazole clearance related to patients’ weight is updated and details about pharmacokinetics in elderly population is updated
Section 6.2 - reference to dextrose is replaced with glucose
Section 6.6 – reference to dextrose is replaced with glucose
Section 10 – the last revision date
Note: Number of editorial changes throughout the SPC have been made such as trade name ‘Noxafil’ replaced with the active substance name ‘posaconazole’, spelling corrections etc.
Updated on 11 November 2021
File name
Noxafil 300mg-conc for sol for inf-LFT-II-062-Oct 2021 QRD-IE.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 1 – What is product used for – Noxafil is first line treatment for infections caused by fungi of the Aspergillus family
Section 2 – What you need to know before you take Noxafil – editorial changes
Section 4 – Possible side effects – frequency of side effect ‘pseudoaldosteronism’ is updated from ‘not known’ to ‘rare’ / spelling corrections / spaces
Section 6 – Date of revision – the last revision date is updated
Info for HCP only – ‘dextrose’ is replaced with ‘glucose’ on all instances
Updated on 23 September 2021
File name
QRD-IE-Noxafil-conc for sol for inf-LFT-PSUSA-Aug2021.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to section 2 - What you need to know before you take Noxafil – interaction with other medicines - co-administration of Noxafil with ASTA (also called tretinoin)
Change to section 6 - Date of revision
Updated on 23 September 2021
File name
NOXAFIL 300mg-conc for sol for infusion-H-C-0610-PSUSA-SPC-IE-en-Aug2021.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
- Section 4.5 – effects of co-administration of Noxafil with ASTA (also called tretinoin); Section 10 – Date of the last text revision is updated
Updated on 05 October 2020
File name
NOXAFIL 300mg-conc for sol for infusion-H-C-0610-IB-061-SPC-IE-en-CRT-Sep2020 (002).pdf.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- 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
SPC change details: Sect 2 – Information about Excipients added (sodium and cyclodextrin); Sect 4.4 - Excipients warnings (sodium and cyclodextrin) added in line with EU Excipient guideline; Sect 10 – Text revision date is updated
Updated on 05 October 2020
File name
QRD-IE-Noxafil-conc for sol for inf-LFT-IB-061-Sep2020 (002).pdf.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 13 November 2019
File name
QRD_IE_Noxafil_300_mg_concentrate_for_solution_for_infusion_PIL_CRT.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Changes to Section 2, Section 4 and Section 6
Updated on 13 November 2019
File name
Noxafil_300_mg_concentrate_for_solution_for_infusion_SPC_CRT.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Section 4.8: Tabulated list of adverse reactions is updated & Section 10- Date of revision of test is updated
Updated on 25 July 2018
File name
QRD NOXAFIL IV PIL MAT Brexit (2).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
- Change to other sources of information section
Updated on 23 July 2018
File name
NOXAFIL-H-C-0610-T-054-PI-en-IE IV (2).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
Changes to section 7. Marketing Authorisation Holder and Section 10 – Date of revision of the text following approval of MA Transfer
Updated on 26 May 2017
File name
PIL_16294_827.pdf
Reasons for updating
- New PIL for new product
Updated on 26 May 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 23 May 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 May 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 on 30 September 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Change to improve clarity and readability
Updated on 28 September 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- 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
Reasons for submission: Approval of EMEA/H/C/000610/IB/0046 (Add information on sodium content)
Updated on 10 May 2016
Reasons for updating
- Change to date of revision
- Correction of spelling/typing errors
Updated on 01 September 2015
Reasons for updating
- Change to date of revision
- Change to dosage and administration
Updated on 24 August 2015
Reasons for updating
- 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
Section 6.6 – Special Precautions for disposal and handling and Change to Section 10 – Date of revision
Reasons for submission: Approval of EMEA/H/C/000610/II/0036
Updated on 28 April 2015
Reasons for updating
- New SPC for medicines.ie
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 April 2015
Reasons for updating
- New PIL for medicines.ie