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Nuwiq powder and solvent for solution for injection

  • Name:

    Nuwiq powder and solvent for solution for injection

  • Company:
    info
  • Active Ingredients:

    simoctocog alfa

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/09/19

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Summary of Product Characteristics last updated on medicines.ie: 5/9/2019
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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Octapharma Ltd

octapharma

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Medicine Name Nuwiq powder and solvent for solution for injection Active Ingredients simoctocog alfa
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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 5 September 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 5 September 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

CC-REG029

Updated on 21 June 2019 SmPC

Reasons for updating

  • New SmPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 29 May 2018 SmPC

Reasons for updating

  • Addition of joint SmPC covering all presentations

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 29 May 2018 PIL

Reasons for updating

  • Addition of joint PIL covering all presentations

Updated on 9 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 October 2017 SmPC

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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change from individual to joint SPC

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

$0$0In section 1 (Name of the medicine product)$0- Addition of 500IU, 1000IU and 2000IU strengths, due to combination of individual SPCs$0$0$0In section 2 (Qualitative and quantitative composition)$0- Addition of 500IU, 1000IU and 2000IU strengths, due to combination of individual SPCs$0$0$0In section 4.2 (Posology and method of administration):$0- Details on treatment monitoring have been expanded and greater detail is given (e.g. using in vitro thromboplastin time assays) $0- Prophylaxis doses have been added$0- Paediatric population data is now available$0$0$0$0In section 4.4 (Special warnings and precautions for use):$0- More information is given about the formation of inhibitors$0- Cardiovascular events is now listed$0$0$0$0In section 4.8 (Undesirable effects):$0- Safety profile has been updated$0- Tabulated list of adverse events has been updated$0$0$0$0In section 5.1 (Pharmacodynamic properties), addition of a reference to a prospective clinical trial in previously untreated patients (PUPs)$0$0

Updated on 19 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 7 June 2017 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided