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Nuwiq powder and solvent for solution for injection *
Pharmacy Only: Prescription

  • Company:

    Octapharma Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    simoctocog alfa

    *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 05 September 2019

File name

Nuwiq PIL - 20190708 - Sep 2019_1567680427.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 05 September 2019

File name

Nuwiq SPC - 20190708 - Sep 2019_1567680377.pdf

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

File name

Nuwiq IE SPC 20180123 - August 2018_1561134048.pdf

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

File name

Nuwiq SPC 20180123 - May 2018.docx

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

File name

Nuwiq PIL 20180123 - May 2018.pdf

Reasons for updating

  • Addition of joint PIL covering all presentations

Updated on 09 November 2017

File name

PIL_17351_315.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 October 2017

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

Reasons for updating

  • New SPC for new product

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

Updated on 07 June 2017

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