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Mozobil 20 mg ml solution for injection

*
Pharmacy Only: Prescription

  • Company:

    Sanofi Genzyme

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Plerixafor

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

Updated on 05 May 2023

File name

IE and NI 1.3.1.1 Summary of Product Characteristics (SmPC) Mozobil.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 05 May 2023

File name

IE and NI 1.3.2.1 Mock-up - Package Leaflet (PIL) Mozobil.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer

Updated on 10 January 2022

File name

1.3.2.1 Mock-up - Package Leaflet (PIL)- Mozobil.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 16 November 2021

File name

1.3.2.2 Mock-up - Carton (CTN)- Mozobil.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 17 November 2020

File name

1.3.2 Mock-up-leaflet IE-MT.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 17 November 2020

File name

1.3.2 Mock-up-leaflet IE-MT.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 16 October 2020

File name

1.3.1 PIL text UKIEMT (1).pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer

Updated on 23 April 2020

File name

776071(iss1) (1).pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 20 February 2020

File name

1.3.1 PIL text UKIEMT.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 13 June 2019

File name

PIL Mozobil SA113.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use

Updated on 22 May 2019

File name

SPC Mozobil 20mg.ml solution for injection SA113.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Sections 4.1, 4.2, 4.8, 5.1, 5.2, 5.3, 7.

- Extension of indication to paediatric patients 1-18 years  

Updated on 14 January 2019

File name

PIL Mozobil 20mg.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 14 January 2019

File name

SPC Mozobil 20mg.pdf

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store.

 

7.       MARKETING AUTHORISATION HOLDER

 

Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

 

Updated on 22 November 2017

File name

PIL_17332_49.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 November 2017

Reasons for updating

  • Improved presentation of PIL

Updated on 26 October 2017

Reasons for updating

  • New PIL for medicines.ie