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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

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Octapharma Ltd

octapharma

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Medicine Name Fibryga, 1 g, powder and solvent for solution for injection/infusion Active Ingredients Human Fibrinogen
Medicine Name gammanorm Active Ingredients Human Normal Immunoglobulin
Medicine Name LG-octaplas solution for infusion Active Ingredients Human Plasma Proteins
Medicine Name Nuwiq powder and solvent for solution for injection Active Ingredients simoctocog alfa
Medicine Name Octaplex 1000 IU coagulation factor IX per vial, powder and solvent for solution for infusion Active Ingredients Human Prothrombin Complex
Medicine Name Octaplex 500 IU coagulation factor IX per vial, powder and solvent for solution for infusion Active Ingredients Human Prothrombin Complex
Medicine Name Panzyga 100 mg/ml solution for infusion Active Ingredients Human Normal Immunoglobulin
Medicine Name Wilate powder and solvent for solution for injection Active Ingredients Factor VIII, von Willebrand factor
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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 SPC

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 SPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 29 May 2018 SPC

Reasons for updating

  • Addition of joint SPC 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 SPC

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 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 7 June 2017 SPC

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