Ursofalk 500mg film-coated tablets
*Company:
DR. FALK PHARMA GMBHStatus:
UpdatedLegal 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 15 November 2024
File name
Ursofalk-tablets-SPC-Nov24-IE.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
To include urticaria and nausea / vomiting under “not known” frequency
Updated on 15 November 2024
File name
Ursofalk-tablets-PIL-Nov24-IE.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
To include urticaria and nausea / vomiting under “not known” frequency
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.
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