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ELOCTA powder and solvent for solution for injection

*
Pharmacy Only: Prescription

  • Company:

    Swedish Orphan Biovitrum Ltd

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Efmoroctocog Alfa

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

Updated on 19 November 2024

File name

Elocta PIL IE NI (Nov 2024).pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 18 October 2024

File name

Elocta SPC IE NI (Oct 2024).pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Update Section 6.3 in SmPC to Unopened vial

Updated on 18 October 2024

File name

Elocta PIL IE NI (Oct 2024).pdf

Reasons for updating

  • Change to section 5 - how to store or dispose

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

 Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII, ATC code: B02BD02

 

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

$07.        MARKETING AUTHORISATIONHOLDER$0$0 $0$0Deleted text:  Biogen IdecLtd,  Innovation House,  70 Norden Road,  Maidenhead, Berkshire,SL6 4AY, United Kingdom$0$0Inserted text:  SwedishOrphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden$0$0 $0$010.      DATE OF REVISION OF THE TEXT$0$0 $0$0Deleted: November 2015$0$0Inserted: 26th March2016 $0

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)

Free text change information supplied by the pharmaceutical company

None provided