ELOCTA powder and solvent for solution for injection
*Company:
Swedish Orphan Biovitrum LtdStatus:
No Recent UpdateLegal 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 19 January 2023
File name
Elocta SPC NI and RoI (Jan 2021).pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 June 2021
File name
Elocta PL NI and RoI (Jan 2021) (2).pdf
Reasons for updating
- Change to further information section
Updated on 17 June 2021
File name
Elocta PL NI and RoI (Jan 2021) (1).pdf
Reasons for updating
- New PIL for new product
Updated on 26 May 2021
File name
Elocta SPC NI and RoI (Jan 2021).pdf
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)
Updated on 02 March 2021
File name
Elocta SPC NI and RoI (Feb 2021).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 September 2020
File name
Elocta PL (August 2020).pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 03 September 2020
File name
Elocta SmPC (August 2020).pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.6 - Special precautions for disposal and other handling
- Removal of Black Inverted Triangle
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 July 2019
File name
Elocta PL (July 2019).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 17 July 2019
File name
Elocta SmPC (July 2019).pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
SmPC section 4.2 and 4.8, and PIL section 4, updated with interim PUPs A data.
Updated on 07 March 2019
File name
Elocta SmPC (Dec 2018).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Addition of long-term clinical data from ASPIRE in SmPC section 4.8 and 5.1
Updated on 04 January 2019
File name
Elocta PL (Dec 2018).pdf
Reasons for updating
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 04 January 2019
File name
Elocta SmPC (Dec 2018).pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 8 - Marketing authorisation number(s)
- 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
Addition of higher strengths
Updated on 24 July 2018
File name
Elocta combined SmPC (Nov 2017).pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 27 February 2018
File name
PIL_16689_197.pdf
Reasons for updating
- New PIL for new product
Updated on 27 February 2018
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 07 December 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 December 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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
4. Clinical particulars
4.4 Special warnings and precautions for use
Inserted (additional text highlighted in bold): The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 20 exposure days.
The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre inhibitors which are transiently present or remain consistently low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
4.8 Undesirable effects
Deleted: Patient’s with haemophilia A may develop neutralizing antibodies (inhibitors) to factor VIII.
Inserted: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ELOCTA.
Inserted: Under MedDRA System Organ Class Adverse reactions Frequency category
Blood and lymphatic system disorders FVIII inhibition Uncommon (PTPs)1
Deleted: Investigations Anti Factor VIII
Antibody positive2 Uncommon
Deleted: Post Marketing Experience In post-marketing experience, FVIII inhibitor development has been observed.
6.3 Shelf life
Unopened vial
3 4 years
10. DATE OF REVISION OF THE TEXT
Inserted: 16 November 2017
Deleted: 12/05/2016
Updated on 04 December 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 16 October 2017
Reasons for updating
- 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
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
10. DATE OF REVISION OF THE TEXT
26/03/2016 12/05/2016
Updated on 13 October 2017
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 April 2016
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 on 11 April 2016
Reasons for updating
- New PIL for medicines.ie
Updated on 27 January 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)