Bronchitol 40 mg, inhalation powder, hard capsules

  • Name:

    Bronchitol 40 mg, inhalation powder, hard capsules

  • Company:
    info
  • Active Ingredients:

    Mannitol

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/04/19

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Summary of Product Characteristics last updated on medicines.ie: 10/4/2019

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Pharmaxis Europe Limited

Pharmaxis Pharmaceuticals Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Bronchitol 40 mg, inhalation powder, hard capsules Active Ingredients Mannitol
Medicine Name Osmohale Inhalation Powder, Hard Capsule Active Ingredients Mannitol
1 - 0 of 2 items.Total: Infinity pages

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 10 April 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 10 April 2019 SmPC

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 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 30 January 2019 SmPC

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 7 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 June 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 30 January 2017 PIL

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 29 January 2017 SmPC

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 PIL

Reasons for updating

  • Removal/change of distributor

Updated on 5 April 2016 SmPC

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 4 April 2016 PIL

Reasons for updating

  • Change to storage instructions

Updated on 28 January 2016 SmPC

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 7 October 2015 PIL

Reasons for updating

  • New PIL for medicines.ie