ELOCTA powder and solvent for solution for injection
- Name:
ELOCTA powder and solvent for solution for injection
- Company:
Swedish Orphan Biovitrum Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/03/21
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Swedish Orphan Biovitrum Ltd
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name ALPROLIX powder and solvent for solution for injection | Active Ingredients Eftrenonacog Alfa |
| Medicine Name DOPTELET 20mg film coated tablets | Active Ingredients Avatrombopag |
| Medicine Name ELOCTA powder and solvent for solution for injection | Active Ingredients efmoroctocog alfa |
| Medicine Name Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe | Active Ingredients Anakinra |
| Medicine Name Orfadin 2mg, 5mg, 10mg and 20mg Capsules | Active Ingredients Nitisinone |
| Medicine Name Orfadin 4mg/ml Oral Suspension | Active Ingredients Nitisinone |
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 2 March 2021 SPC
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 2 March 2021 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 16 September 2020 PIL
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 3 September 2020 SPC
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 17 July 2019 SPC
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 7 March 2019 SPC
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 4 January 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 4 January 2019 SPC
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 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 27 February 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 7 December 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 7 December 2017 SPC
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 4 December 2017 PIL
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 SPC
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 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 April 2016 SPC
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 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 27 January 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)