PENTHROX 3mL inhalation vapour, liquid
- Name:
PENTHROX 3mL inhalation vapour, liquid
- Company:
Galen Pharma Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/10/20

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Galen Pharma Ireland Limited

Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 15 January 2021 Ed-HCP
Reasons for updating
- Add New Doc
Updated on 24 October 2020 PIL
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 SPC
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 6 August 2020 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 28 May 2020 Ed-HCP
Reasons for updating
- Add New Doc
Updated on 28 May 2020 Ed-HCP
Reasons for updating
- Add New Doc
Updated on 15 May 2020 Ed-Ptnt
Reasons for updating
- Add New Doc
Updated on 9 April 2020 SPC
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 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 14 August 2019 SPC
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 PIL
Reasons for updating
- Addition of manufacturer
Updated on 23 January 2019 PIL
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 SPC
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 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 15 August 2017 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 9 March 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 9 March 2017 SPC
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 7 March 2017 PIL
Reasons for updating
- Change to section 3 - how to take/use
Updated on 16 August 2016 SPC
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 PIL
Reasons for updating
- New PIL for new product
Penthrox Administration ChecklistRisk Minimisation Materials
(Click to Download)
Penthrox Administration Checklist one-sidedRisk Minimisation Materials
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Penthrox Administration GuideRisk Minimisation Materials
(Click to Download)
Educational Materials for Medicines
Educational Materials for Medicines
Penthrox Patient Alert CardRisk Minimisation Materials
(Click to Download)
Educational Materials for Medicines
Educational Materials for Medicines