Ursofalk 500mg film-coated tablets

*
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):

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

Updated on 03 February 2015

Reasons for updating

  • New SPC for new product

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

Updated on 03 February 2015

Reasons for updating

  • Change to paediatric information
  • 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 5 - Pharmacological 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

Updated template.
Additional paediatric indication.
Updated safety information.

Updated on 27 January 2015

File name

PIL_15651_874.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 January 2015

Reasons for updating

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

Updated on 01 March 2013

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 28 February 2013

Reasons for updating

  • New PIL for new product