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Budenofalk 9mg gastro-resistant granules

  • Name:

    Budenofalk 9mg gastro-resistant granules

  • Company:
    info
  • Active Ingredients:

    Budesonide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/08/19

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Summary of Product Characteristics last updated on medicines.ie: 8/8/2019

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DR. FALK PHARMA GMBH

Company Products

Medicine NameActive Ingredients
Medicine Name Budenofalk 2mg/dose rectal foam Active Ingredients Budesonide
Medicine Name Budenofalk 3mg gastro-resistant capsules Active Ingredients Budesonide
Medicine Name Budenofalk 9mg gastro-resistant granules Active Ingredients Budesonide
Medicine Name Salofalk 1.5g gastro-resistant prolonged-release granules Active Ingredients Mesalazine
Medicine Name Salofalk 1000mg gastro-resistant prolonged-release granules Active Ingredients Mesalazine
Medicine Name Salofalk 1g Suppositories Active Ingredients Mesalazine
Medicine Name Salofalk 1g/Actuation Rectal Foam Active Ingredients Mesalazine
Medicine Name Salofalk 250mg gastro-resistant tablets Active Ingredients Mesalazine
Medicine Name Salofalk 250mg Suppositories Active Ingredients Mesalazine
Medicine Name Salofalk 3g Gastro-resistant prolonged-release granules Active Ingredients Mesalazine
Medicine Name Salofalk 4g/60ml Enema Active Ingredients Mesalazine
Medicine Name Salofalk 500mg gastro-resistant prolonged-release granules Active Ingredients Mesalazine
Medicine Name Ursofalk 250mg Hard Capsules Active Ingredients Ursodeoxycholic Acid
Medicine Name Ursofalk 250mg/5ml Suspension Active Ingredients Ursodeoxycholic Acid
Medicine Name Ursofalk 500mg film-coated tablets Active Ingredients Ursodeoxycholic Acid
1 - 0 of 15 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 8 August 2019 PIL

Reasons for updating

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

Updated on 8 August 2019 SPC

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 7 May 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 3 May 2019 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 8 August 2017 SPC

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 8 August 2017 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 3 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 August 2017 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 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 21 October 2016 SPC

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 PIL

Reasons for updating

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

Updated on 25 May 2016 SPC

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 SPC

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 PIL

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 7 December 2012 SPC

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 SPC

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 SPC

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 SPC

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 PIL

Reasons for updating

  • New PIL for new product