PENTHROX 3mL inhalation vapour, liquid
*Company:
Galen Pharma Ireland 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 01 August 2024
File name
PENTHROX IE PIL.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 01 August 2024
File name
Penthrox IE SPC.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)
File name
Penthrox ROI Administration Checklist One-Sided Oct 2023.pdf
Reasons for updating
- Replace File
File name
Penthrox ROI Administration Checklist Oct 2023.pdf
Reasons for updating
- Replace File
File name
Penthrox ROI Administration Checklist One-Sided Oct 2023.pdf
Reasons for updating
- Replace File
File name
Penthrox ROI Administration Checklist Oct 2023.pdf
Reasons for updating
- Replace File
File name
Penthrox ROI Administration Checklist One-Sided Oct 2023.pdf
Reasons for updating
- Replace File
File name
Penthrox ROI Administration Checklist Oct 2023.pdf
Reasons for updating
- Replace File
File name
Penthrox ROI Admin Guide July 2023 (MAT-PEN-IE-000383).pdf
Reasons for updating
- Add New Doc
Updated on 17 May 2023
File name
PENTHROX IE PIL.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 03 April 2023
File name
PENTHROX IE PIL.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 date of revision
Updated on 03 April 2023
File name
Penthrox IE SPC.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 January 2023
File name
Penthrox IE SPC.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 January 2022
File name
Penthrox IE PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 18 January 2022
File name
Penthrox IE SPC.pdf
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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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)
File name
Penthrox ROI Administration Guide (June 2021).pdf
Reasons for updating
- Replace File
File name
Penthrox ROI Administration Checklist (June 2021).pdf
Reasons for updating
- Replace File
File name
Penthrox ROI Administration Checklist One-Sided (June 2021).pdf
Reasons for updating
- Replace File
File name
Penthrox ROI Patient Alert Card (June 2021).pdf
Reasons for updating
- Replace File
Updated on 26 April 2021
File name
Penthrox IE PIL.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 26 April 2021
File name
Penthrox IE SPC.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Penthrox Administration Guide-HCP use (Dec 2020).pdf
Reasons for updating
- Add New Doc
Updated on 24 October 2020
File name
Penthrox IE PIL.pdf
Reasons for updating
- 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 2 - pregnancy, breast feeding and fertility
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 October 2020
File name
Penthrox IE SPC.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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)
Updated on 06 August 2020
File name
Penthrox IE PIL.pdf
Reasons for updating
- Change to section 6 - date of revision
File name
Penthrox Administration Checklist (one-sided)-HCP use.pdf
Reasons for updating
- Add New Doc
File name
Penthrox Administration Checklist-HCP use.pdf
Reasons for updating
- Add New Doc
File name
Penthrox Patient Alert Card-patient use.pdf
Reasons for updating
- Add New Doc
Updated on 09 April 2020
File name
Penthrox IE SPC.pdf
Reasons for updating
- 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)
Updated on 14 August 2019
File name
Penthrox IE PIL.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 14 August 2019
File name
Penthrox IE SPC.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The name of the Marketing Authorisation Holder (MAH) has changed from Medical Developments Penthrox limited to Medical Developments MD&P Limited.
Updated on 22 March 2019
File name
Penthrox IE PIL.pdf
Reasons for updating
- Addition of manufacturer
Updated on 23 January 2019
File name
Penthrox IE PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
Updated on 23 January 2019
File name
Penthrox IE SPC.pdf
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 August 2018
File name
Penthrox IE SPC.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 August 2017
File name
PIL_16820_418.pdf
Reasons for updating
- New PIL for new product
Updated on 15 August 2017
Reasons for updating
- Change to section 6 - manufacturer
Updated on 09 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 March 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
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 March 2017
Reasons for updating
- Change to section 3 - how to take/use
Updated on 16 August 2016
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 15 August 2016
Reasons for updating
- New PIL for new product