Bronchitol 40 mg, inhalation powder, hard capsules *
Pharmacy Only: Prescription

  • Company:

    Pharmaxis Europe Limited
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 03 August 2022

File name

62ea10ce6b152.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Change to section 6 - manufacturer address ; Change to section 6 - date of revision

Updated on 14 October 2020

File name

20201005 Bronchitol_PIL_EN_1602636132.pdf

Reasons for updating

  • Change in co-marketing arrangement

Updated on 21 January 2020

File name

emea-combined-h1252-en_1579650825.pdf

Reasons for updating

  • Change in co-marketing arrangement

Updated on 10 April 2019

File name

20190225 Bronchitol_PIL_EN_1554858511.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 10 April 2019

File name

20190225 Bronchitol_SPC_EN_1554858613.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 30 January 2019

File name

20190123 Bronchitol_PIL_EN - EMC_1548822662.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 30 January 2019

File name

20190123 Bronchitol_SPC_EN_1548822855.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update of Marketing Authorisation Holder

Updated on 07 June 2017

File name

PIL_16500_290.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 June 2017

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 30 January 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents

Updated on 29 January 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 29 January 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.2, 4.8, 5.2, 6.4 and 6.5 were updated with administrative changes only to adhere to the QRD template. No changes were made to the actual content.

Updated on 19 April 2016

Reasons for updating

  • Removal/change of distributor

Updated on 05 April 2016

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In Section 6.4 Special Precautions for Storage - the storage conditons have increased from 25 degrees to 30 degrees.

Updated on 04 April 2016

Reasons for updating

  • Change to storage instructions

Updated on 28 January 2016

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 07 October 2015

Reasons for updating

  • New PIL for medicines.ie