Hemlibra 150 mg/mL Solution for Injection *
Pharmacy Only: Prescription

  • Company:

    Roche Registration GmbH
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

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

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 13 August 2021

File name

SPC Hemlibra_30-150mg_Art.61.3_N-0024_10Aug2021_Clean _1628850751.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 13 August 2021

File name

PIL Hemlibra_150mg_Art.61.3_N-0024_10Aug2021_Clean_1628850724.pdf

Reasons for updating

  • New PIL for new product

Updated on 09 December 2020

File name

SmPC_Hemlibra_IB-020_07-Dec-2020_Clean_1607507243.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)

EDM Updated on 25 November 2020

File name

Hemlibra HCP Guide IE Version 2.4.0_1606305911.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 25 November 2020

File name

Hemlibra Lab Information Sheet IE Version 2.4.0_1606305911.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 25 November 2020

File name

Hemlibra Patient Alert Card IE Version 1.3.0_1606305910.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 25 November 2020

File name

Hemlibra Patient Guide IE Version 2.4.0_1606305910.pdf

Reasons for updating

  • Add New Doc

Updated on 13 October 2020

File name

Irish PIL Hemlibra 150 mgmL_II-002_11-Mar-2019_1602595309.pdf

Reasons for updating

  • Previous version of PIL reinstated

Updated on 13 October 2020

File name

Irish SPC Hemlibra_IB-015_23-Jan-2020_1602595053.pdf

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

File name

PIL_Hemlibra_150mg_IB-017_19-Aug-2020_clean_1598534843.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_1598534953.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_150mg_IB-017_19-Aug-2020_clean_1598534843.pdf

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 04 February 2020

File name

SmPC_Hemlibra_IB-015_23-Jan-2020_clean_1580809333.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 29 July 2019

File name

ie-mt-pil-hemlibra-clean-190319-30mg-ml-sol-inj-v2_1564395340.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 23 April 2019

File name

SmPC Hemlibra 30-150 mgmL solution for inj_1556025502.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 5.0 150 mgmL solution for injection Clean_1553093799.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
  • Change to, or new use for medicine

Updated on 20 March 2019

File name

Irish SmPC 6.0 150-30 mgmL solution for injection Clean_1553094349.pdf

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

File name

uk-ie-mt-spc-hemlibra-clean-190214-30mg-150mg-ml-sol-inj_1550575254.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_1540543815.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-180823-150mg-ml-sol-inj_1535618402.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_1535618458.pdf

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

File name

uk-ie-mt-pil-hemlibra-clean-180809-150mg-ml-sol-inf_1534406631.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-180504-150mg-150-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_17425_794.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