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Budenofalk 9mg gastro-resistant granules

*
Pharmacy Only: Prescription

  • Company:

    DR. FALK PHARMA GMBH

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Budesonide

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

Updated on 23 February 2022

File name

Budenofalk-granules-leaflet-uk-ie-nov21.pdf

Reasons for updating

  • Change to section 6 - what the product contains

Free text change information supplied by the pharmaceutical company

name change - citric acid

Updated on 23 February 2022

File name

Budenofalk-9mg-granules-IE-Nov21.pdf

Reasons for updating

  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Name change - citric acid

Updated on 22 March 2021

File name

Budenofalk-granules-leaflet-uk-ie-feb21.pdf

Reasons for updating

  • Change to section 1 - what the product is used for

Free text change information supplied by the pharmaceutical company

changed indication from collagenous colitis to microscopic colitis.

Updated on 22 March 2021

File name

Budenofalk-9mg-granules-IE-feb21.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Updated indication from collagenous colitis to microscopic colitis; added details relating to microscopic colitis; updates in compliance with the QRD template.

Updated on 08 August 2019

File name

Budenofalk-granules-leaflet-uk-ie Aug19.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 08 August 2019

File name

Budenofalk-9mg-granules-IE-Aug19.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

Expanded description

Updated on 07 May 2019

File name

Budenofalk-granules-leaflet-uk-ie Feb19.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 03 May 2019

File name

Budenofalk-9mg-granules-IE-Feb19.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 08 August 2017

Reasons for updating

  • New SPC for new product

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

Updated on 08 August 2017

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 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Information added on visual disturbances.

Updated on 03 August 2017

File name

PIL_15082_861.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 August 2017

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 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 21 October 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Frequency of undesirable effects changed and some new/renamed following recent PSUR$0Admin/spelling corrections made.$0

Updated on 20 October 2016

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 25 May 2016

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Increased shelf life

Updated on 12 March 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2:  Minor/typo update$0Section 4.1 - Addition of new indication:  Induction of remission in patients with mild to moderate active Crohn's disease affecting the ileum and/or the ascending colon$0$0Section 4.2 - New heading for Crohn's disease$0$0Section 4.4 - Comment on extraintestinal effects and on doping tests$0$0Section 4.8 - Reformat; addition of how to report side effects$0$0Section 5.1 - Information from clinical trials in Crohn's disease$0$0Section 10 - Revision date$0$0$0$0

Updated on 10 March 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Changes to therapeutic indications
  • Addition of information on reporting a side effect.

Updated on 07 December 2012

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Corrected approval date

Updated on 20 November 2012

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Shelf life changed from 2 to 3 years

Updated on 27 January 2012

Reasons for updating

  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

The MA number was incorrect. Typo - no change in actual MAH

Updated on 25 July 2011

Reasons for updating

  • New SPC for new product

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 22 July 2011

Reasons for updating

  • New PIL for new product