Fibryga, 1 g, powder and solvent for solution for injection/infusion
Product Information *
Company:
Octapharma LtdStatus:
UpdatedActive Ingredients :
This medicinal product is subject to additional monitoring.
*Additional information is available upon request
Legal Category:
Product subject to medical prescription which may not be renewed (A)
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 27 July 2021
File name
Fibryga SPC Ireland - 20210714_1627377174.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of Fibryga SmPC and PIL following Article 46 Paediatric Worksharing procedure
Updated on 27 July 2021
File name
Fibryga PIL Ireland - 20210714_1627377052.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
Free text change information supplied by the pharmaceutical company
Update of Fibryga SmPC and PIL following Article 46 Paediatric Worksharing procedure
Updated on 11 September 2020
File name
Fibryga IE PIL - 20200608 - Sep 2020_1599834954.pdf
Reasons for updating
- New PIL for new product
Updated on 11 September 2020
File name
FIBRYGA IE SPC - Sep 2020 - 20200904_1599834914.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 September 2020
File name
FIBRYGA IE SPC - Sep 2020 - 20200904_1599834876.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)