Hemlibra 30 mg/mL Solution for Injection
*Company:
Roche Registration GmbHStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 28 February 2024
File name
SmPC_Hemlibra IB-040_20Feb2024.pdf
Reasons for updating
- 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
EU SPC and PIL EMEA/H/C/004406/IB/0040. Addition of vial adapter with filter (new IFU).
Updated on 28 February 2024
File name
PIL_Hemlibra 30 mg IB-040_20Feb2024-v2.pdf
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 7 - Instructions for use
Free text change information supplied by the pharmaceutical company
EU SPC and PIL EMEA/H/C/004406/IB/0040. Addition of vial adapter with filter (new IFU).
Updated on 12 December 2023
File name
PIL Hemlibra_30mg_II-0037_09Nov2023_clean.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 12 December 2023
File name
SmPC Hemlibra_30_150mg_II-0037_09Nov2023.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
- 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 not be renewed (A)
File name
Hemlibra HCP Guide IE Version 4.7.0.pdf
Reasons for updating
- Replace File
File name
Hemlibra Lab Information Sheet IE Version 4.7.0.pdf
Reasons for updating
- Replace File
File name
Hemlibra Patient Card IE Version 4.7.0.pdf
Reasons for updating
- Replace File
File name
Hemlibra Patient Guide IE Version 4.7.0.pdf
Reasons for updating
- Replace File
Updated on 05 May 2023
File name
PIL Hemlibra_30mg_IA-XXXX_02May2023.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 15 March 2023
File name
SmPC Hemlibra_30_150mg_II-0033_02Mar2023.pdf
Reasons for updating
- 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 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
- 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 not be renewed (A)
Updated on 01 February 2023
File name
PIL Hemlibra_30mg_II-0027_23Jan2023.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Removal of Black Inverted Triangle
Updated on 01 February 2023
File name
Hemlibra Smpc dated 23 Jan 2023.pdf
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic 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 not be renewed (A)
Updated on 21 September 2022
File name
SmPC Hemlibra_30_150mg_Renewal2022_15_Sep_2022.pdf
Reasons for updating
- 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 21 September 2022
File name
PIL Hemlibra_30mg_Renewal2022_15_Sep_2022.pdf
Reasons for updating
- Correction of spelling/typing errors
- Change to date of revision
Updated on 22 April 2022
File name
PIL_Hemlibra_IV_30mg_II-0025_10_Mar_2022.pdf
Reasons for updating
- New PIL for new product
Updated on 22 April 2022
File name
SmPC_Hemlibra_IV_30_150mg_II-0025_10_Mar_2022.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 not be renewed (A)
Updated on 14 December 2021
File name
SmPC_Hemlibra_II-0026_28-Oct-2021_Clean.pdf
Reasons for updating
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/004406/II/26. Hypersensitivity in Section 4.8 of the EU-SmPC (Section 4 of the leaflet).
Updated on 13 August 2021
File name
SPC Hemlibra_30-150mg_Art.61.3_N-0024_10Aug2021_Clean .pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 09 December 2020
File name
Irish PIL Hemlibra 30 mgmL_II-002_11-Mar-2019.pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 09 December 2020
File name
SmPC_Hemlibra_IB-020_07-Dec-2020_Clean.pdf
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)
File name
Hemlibra Patient Alert Card IE Version 1.3.0.pdf
Reasons for updating
- Add New Doc
File name
Hemlibra Patient Guide IE Version 2.4.0.pdf
Reasons for updating
- Add New Doc
File name
Hemlibra Lab Information Sheet IE Version 2.4.0.pdf
Reasons for updating
- Add New Doc
File name
Hemlibra HCP Guide IE Version 2.4.0.pdf
Reasons for updating
- Add New Doc
Updated on 13 October 2020
File name
Irish PIL Hemlibra 30 mgmL_II-002_11-Mar-2019.pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 13 October 2020
File name
Irish SPC Hemlibra_IB-015_23-Jan-2020.pdf
Reasons for updating
- Previous version of SPC reinstated
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Re publication SmPC EMEA/H/C/004406/IB/015 approved on 23-Jan-2020
Updated on 13 October 2020
File name
PIL_Hemlibra_30mg_IB-017_19-Aug-2020_clean.pdf
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
File name
Irish SPC Hemlibra_V9.0_IB-017_19-Aug-2020_Clean.pdf
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
File name
PIL_Hemlibra_30mg_IB-017_19-Aug-2020_clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 04 February 2020
File name
SmPC_Hemlibra_IB-015_23-Jan-2020_clean.pdf
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 08 July 2019
File name
uk-ie-mt-pil-Hemlibra-clean-190319-30 mgmL-sol.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 29 April 2019
File name
uk-ie-mt-pil-Hemlibra-clean-190319-30 mgmL-sol.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 23 April 2019
File name
SmPC Hemlibra 30-150 mgmL solution for inj.pdf
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
File name
Irish PIL 5.0 30 mgmL solution for injection Clean.pdf
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
Updated on 20 March 2019
File name
Irish SmPC 6.0 150-30 mgmL solution for injection Clean.pdf
Reasons for updating
- 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
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
File name
uk-ie-mt-spc-hemlibra-clean-190214-30mg-150mg-ml-sol-inj.pdf
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
File name
uk-ie-mt-spc-hemlibra-181022-clean-30mg-150mg-ml-sol-inj.pdf
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
File name
uk-ie-mt-pil-hemlibra-clean-180823-30mg-ml-sol-inj.pdf
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
File name
uk-ie-mt-spc-hemlibra-clean-180823-30mg-150mg-ml-sol-inj.pdf
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
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 21 August 2018
File name
uk-ie-mt-pil-hemlibra-clean-180809-30mg-ml-sol-inf.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 13 May 2018
File name
uk-ie-mt-pil-hemlibra-clean-180504-30mg-ml-sol-inj.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 08 March 2018
File name
PIL_17424_366.pdf
Reasons for updating
- New PIL for new product
Updated on 08 March 2018
Reasons for updating
- Correction of spelling/typing errors
Updated on 01 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 March 2018
Reasons for updating
- New PIL for new product