Noxafil 100mg Gastro-resistant Tablets
*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-gastro resist tabs-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-100mg gastro resistant tabs-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 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 10 – the last revision date.
Updated on 14 February 2023
File name
NOXAFIL 100mg gastro resistant tabs-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-gast-resist tabs-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 100mg gastro resistant tabs-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 5.3 - 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 – Reference to new formulation (gastro resistant powder and solvent for oral suspension).
Section 5.1 & 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-gast-resist tabs-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 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 date of revision - The last revision date is updated.
Updated on 11 November 2021
File name
NOXAFIL 100mg gastro resistant tabs-H-C-0610-II-062-SPC-IE-en-Oct 2021.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - 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
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 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-gast resist tabs100mg QRD-IE-LFT-II-062-Oct 2021.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
Updated on 23 September 2021
File name
QRD-IE-Noxafil-gast-resist tabs-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
interaction with other medicines - co-administration of Noxafil with ASTA (also called tretinoin)
Updated on 23 September 2021
File name
NOXAFIL 100mg-gastro resistant tabs-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
QRD-IE-Noxafil-gast resist tabs-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 05 October 2020
File name
NOXAFIL 100mg-gastro resistant tabs-H-C-0610-IB-061-SPC-IE-en-CRT-Sep2020 (002).pdf.pdf
Reasons for updating
- 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
Sect 4.4 - Excipients warning (sodium) added in line with EU Excipient guideline; Sect 10 – Text revision date is updated
Updated on 13 November 2019
File name
QRD_IE_Noxafil_100 mg_gastro-resistant_tablets_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_100_mg_gastro-resistant tablets_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 PIL TAB 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 GR Tabs (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_16051_983.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
SPC change details: Updates to sections 4.4, 4.5, and 10 as a result of approval of Type II variation EMEA/H/C/000610/II/0048 to strengthen language on drug-drug interaction for azole antifungals, including posaconazole, with vincristine.
Updated on 30 September 2016
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 04 August 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 04 August 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Change to dosage and administration
Updated on 28 August 2015
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 28 August 2015
Reasons for updating
- Change to further information section
- Change to date of revision
- Correction of spelling/typing errors
Updated on 05 November 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to improve clarity and readability
Updated on 06 October 2014
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 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
- 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
Updates to SPC sections 4.2. 4.4, 4.5, 4.6, 4.7, 4.8, 5.2 & 10
Updated on 01 August 2014
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 30 July 2014
Reasons for updating
- New PIL for new product