PENTHROX 3mL inhalation vapour, liquid *
Pharmacy Only: Prescription

  • Company:

    Galen Pharma Ireland Limited
  • Status:

    Updated
  • Legal 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

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 18 January 2022

File name

Penthrox IE PIL_1642519789.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_1642519733.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)

EDM Updated on 28 June 2021

File name

Penthrox ROI Administration Guide (June 2021)_1624874329.pdf

Reasons for updating

  • Replace File

EDM Updated on 28 June 2021

File name

Penthrox ROI Administration Checklist One-Sided (June 2021)_1624874279.pdf

Reasons for updating

  • Replace File

EDM Updated on 28 June 2021

File name

Penthrox ROI Administration Checklist (June 2021)_1624874279.pdf

Reasons for updating

  • Replace File

EDM Updated on 28 June 2021

File name

Penthrox ROI Patient Alert Card (June 2021)_1624874279.pdf

Reasons for updating

  • Replace File

Updated on 26 April 2021

File name

Penthrox IE PIL_1619448416.pdf

Reasons for updating

  • Removal of Black Inverted Triangle

Updated on 26 April 2021

File name

Penthrox IE SPC_1619448309.pdf

Reasons for updating

  • Removal of Black Inverted Triangle

Legal category:Product subject to medical prescription which may not be renewed (A)

EDM Updated on 15 January 2021

File name

Penthrox Administration Guide-HCP use (Dec 2020)_1610702935.pdf

Reasons for updating

  • Add New Doc

Updated on 24 October 2020

File name

Penthrox IE PIL_1603549519.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_1603548641.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_1596728070.pdf

Reasons for updating

  • Change to section 6 - date of revision

EDM Updated on 28 May 2020

File name

Penthrox Administration Checklist (one-sided)-HCP use_1590678636.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 28 May 2020

File name

Penthrox Administration Checklist-HCP use_1590678462.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 15 May 2020

File name

Penthrox Patient Alert Card-patient use_1589534742.pdf

Reasons for updating

  • Add New Doc

Updated on 09 April 2020

File name

Penthrox IE SPC_1586421544.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_1565787673.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 14 August 2019

File name

Penthrox IE SPC_1565787557.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_1553254506.pdf

Reasons for updating

  • Addition of manufacturer

Updated on 23 January 2019

File name

Penthrox IE PIL_1548256683.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_1548256001.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_1534514396.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

Update of the instruction diagrams. 

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

None provided

Updated on 15 August 2016

Reasons for updating

  • New PIL for new product