Hemlibra 150 mg/mL Solution for Injection

  • Name:

    Hemlibra 150 mg/mL Solution for Injection

  • Company:
    info
  • Active Ingredients:

    Emicizumab

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/10/20

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Summary of Product Characteristics last updated on medicines.ie: 13/10/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Roche Registration GmbH

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Medicine Name Hemlibra 150 mg/mL Solution for Injection Active Ingredients Emicizumab
Medicine Name Hemlibra 30 mg/mL Solution for Injection Active Ingredients Emicizumab
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Medicine Name OCREVUS 300 mg concentrate for solution for infusion Active Ingredients Ocrelizumab
Medicine Name Pegasys 90, 135 and 180 micrograms solution for injection in pre-filled syringe Active Ingredients Peginterferon alfa-2a
Medicine Name Perjeta 420 mg Concentrate for Solution for Infusion Active Ingredients Pertuzumab
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Medicine Name RoActemra 162 mg solution for injection in pre-filled pen Active Ingredients tocilizumab
Medicine Name RoActemra 162 mg solution for injection in pre-filled syringe Active Ingredients tocilizumab
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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 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 25 November 2020 Ed-HCP

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

Reasons for updating

  • Previous version of SmPC reinstated

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

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

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

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Reasons for updating

  • Change to section 6.3 - Shelf life

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

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

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

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

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

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

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

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 1 March 2018 PIL

Reasons for updating

  • New PIL for new product
  • Hemlibra (emicizumab): Laboratory Professional GuideRisk Minimisation Materials

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  • Hemlibra (emicizumab): Healthcare Professional Guide Important Risk Minimisation Information for Healthcare ProfessionalsRisk Minimisation Materials

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  • Hemlibra (emicizumab): Patient/Carer Guide Important Risk Minimisation Information for PatientsRisk Minimisation Materials

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  • Hemlibra (emicizumab): Patient Alert CardRisk Minimisation Materials

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