Ursofalk 250mg/5ml Suspension

  • Name:

    Ursofalk 250mg/5ml Suspension

  • Company:
    info
  • Active Ingredients:

    Ursodeoxycholic Acid

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/08/15

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Summary of Product Characteristics last updated on medicines.ie: 5/2/2015
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DR. FALK PHARMA GMBH

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Medicine Name Salofalk 250mg gastro-resistant tablets Active Ingredients Mesalazine
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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 11 August 2015 PIL

Reasons for updating

  • Change due to harmonisation of PIL
  • Addition of joint PIL covering all presentations

Updated on 11 August 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 February 2015 SmPC

Reasons for updating

  • Change to paediatric information
  • Change to section 4 - Clinical particulars
  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Updated template.
Additional paediatric indication.
Updated safety information.

Updated on 5 February 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 27 January 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 30 March 2011 PIL

Reasons for updating

  • Deletion of a pack size
  • Presentation currently not marketed.

Updated on 29 March 2011 SmPC

Reasons for updating

  • New SPC for new product
  • Presentation currently not marketed.

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 28 March 2011 PIL

Reasons for updating

  • New PIL for new product