Hemlibra 150 mg/mL Solution for Injection
- Name:
Hemlibra 150 mg/mL Solution for Injection
- Company:
Roche Registration GmbH
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/12/20
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Roche Registration GmbH
Company Products
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 9 December 2020 PIL
Reasons for updating
- Previous version of PIL reinstated
Updated on 9 December 2020 SPC
Reasons for updating
- 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 not be renewed (A)
Updated on 25 November 2020 Ed-HCP
Reasons for updating
- Add New Doc
Updated on 25 November 2020 Ed-HCP
Reasons for updating
- Add New Doc
Updated on 25 November 2020 Ed-Ptnt
Reasons for updating
- Add New Doc
Updated on 25 November 2020 Ed-Ptnt
Reasons for updating
- Add New Doc
Updated on 13 October 2020 PIL
Reasons for updating
- Previous version of PIL reinstated
Updated on 13 October 2020 SPC
Reasons for updating
- Previous version of SPC reinstated
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 13 October 2020 PIL
Reasons for updating
- Previous version of PIL reinstated
Free text change information supplied by the pharmaceutical company
Re publication PIL EMEA/H/C/004406/II/0002 approved on 11-Mar-2019
Updated on 27 August 2020 SPC
Reasons for updating
- Change to section 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 27 August 2020 PIL
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
- Change to date of revision
Updated on 4 February 2020 SPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/004406/IB/015.
Type IB w/o linguistic review Update to m1.10 to include PDCO OPINION recording outcome of PIP compliance check as part of the marketing authorisation documentation available in eCTD view, and to claim the PIP reward of 6 months extension to the SPC (Supplementary Protection Certificate).
Updated on 29 July 2019 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 23 April 2019 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
HEMLIBRA, EMEA/H/C/004406/IB/011, Shelf life extension to 3 years for drug product (all strengths except 30mg/mL)
Updated on 20 March 2019 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to, or new use for medicine
Updated on 20 March 2019 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Type II variation to extend the use of Hemlibra for routine prophylaxis of bleeding episodes in patients with haemophilia A without factor VIII inhibitors. Update the SmPC and Package Leaflet with 2 additional posologies (Q2 and Q4W) for patients with haemophilia A with and without factor VIII inhibitors.
Updated on 19 February 2019 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/PSUSA/10668/201805 assessment resulting in updates to SmPC section 5.1, Immunogenicity – ADA data
Updated on 26 October 2018 SPC
Reasons for updating
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Type IB07 Shelf life extension to 30 months
Updated on 30 August 2018 PIL
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 30 August 2018 SPC
Reasons for updating
- Change to section 6.2 - Incompatibilities
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Type IB/05 - To register the use of a vial adapter as an additional option to the use of a transfer needle to perform the transfer of the medicinal product from the vial to the syringe
Updated on 16 August 2018 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 13 May 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 8 March 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 8 March 2018 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 1 March 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 1 March 2018 PIL
Reasons for updating
- New PIL for new product
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