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  • GRANOCYTE 13 million IU/mL, powder and solvent for solution for injection/infusion in a pre-filled syringe

GRANOCYTE 13 million IU/mL, powder and solvent for solution for injection/infusion in a pre-filled syringe

*
Pharmacy Only: Prescription

  • Company:

    Chugai Pharma France S.A.S.

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Lenograstim

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

Updated on 25 September 2024

File name

PIL - Ireland - clean - Apr 2024.pdf

Reasons for updating

  • Joint PIL superseded by individual PILs

Updated on 05 December 2022

File name

ie-spc-Granocyte 13-v103-clean-approved Nov 2022.pdf

Reasons for updating

  • Change to MA holder contact details

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

Updated on 05 December 2022

File name

ie-pl-clean.pdf

Reasons for updating

  • Change to MA holder contact details

Updated on 12 May 2022

File name

1.3.1 G13 SmPC - IRE - v100 - clean - Approved March 2022.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Revision to text on splenomegaly/splenic rupture

Updated on 12 May 2022

File name

1.3.1 PIL - UK and Ireland- v100 - Approved IE Mar 22 - UK May 22.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

Revision of text on splenomegaly/splenic rupture

Updated on 21 December 2020

File name

1.3.1 PIL - UK and Ireland- v97 - Approved Nov 2020.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 21 December 2020

File name

1.3.1 G13 SmPC - IRE - v97 - clean - Approved Nov 2020.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 26 February 2020

File name

1.3.1 G13 SmPC - IRE - approved January 2020.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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

Updated on 26 February 2020

File name

1.3.1 PIL - UK and Ireland- Approved Dec 2019.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - excipient warnings
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 16 April 2019

File name

1.3.1 PIL - Clean - Approved IRE Mar 2019.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 16 April 2019

File name

1.3.1 SmPC Clean G13 - IRE - approved Mar 2019.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Updated on 04 March 2019

File name

1.3.1 PIL - Clean - Approved IRE Feb 2019.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 04 March 2019

File name

1.3.1 SmPC G13 - IRE - approved Feb 2019.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 20 July 2018

File name

1.3.1 PIL - Clean - UK and IRE.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 July 2018

File name

1.3.1 PIL - Clean - UK and IRE.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 July 2018

File name

1.3.1 SmPC G13 - Clean - IRE.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 24 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 24 January 2018

File name

PIL_14839_703.pdf

Reasons for updating

  • New PIL for new product

Updated on 24 January 2018

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

- In sections, 2 4.2, 4.3, 4.6 and 5.1 wording updating to align with latest QRD template, headings inserted
- In section 4.4 information about Glomerulonephritis added
- In section 4.8 (undesirable effects) musculoskeletal pain and glomerulonephritis added
- In section 10 date of revision amended

Updated on 24 January 2018

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents

Updated on 02 October 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Section 4.4 (special warnings and precautions) of the SPC was changed to introduce the potential risk of Sickle Cell Disease crisis.

Updated on 01 October 2015

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 01 December 2014

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

In section 6.3, the shelf-life has been changed from 2 years to 30 months.
In section 10, the date of revision is now November 2014.

Updated on 15 October 2014

Reasons for updating

  • Improved electronic presentation

Updated on 12 September 2014

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 12 March 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

In section 4.4 (special warnings and precautions for use), description of Capillary leak syndrome is added.
In section 4.8 (undesirable effects), description of Capillary leak syndrome as a post-marketing life-threatening adverse drug reaction and its frequency "uncommon" have been added.
In section 4.8 reporting of suspected adverse reactions has been added.
In section 10 the date of revision is now March 2014.

Updated on 12 March 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 06 September 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Addition of joint PIL covering all presentations

Updated on 05 September 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Change to section 4.3 - Contraindications

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

Free text change information supplied by the pharmaceutical company

In Section 4.3, "see section 4.4" has been added in relation to hypersensitivity.
In Section 4.4, the following statement has been added, "The tip cap composition of the pre-filled syringe contains latex rubber which may cause severe allergic reactions in predisposed subjects."
In Section 6.5, reference to the tip cap and latex has been added.
The date of revision has changed to August 2013.

Updated on 12 November 2012

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Correction of spelling/typing errors

Updated on 28 August 2012

Reasons for updating

  • Change to paediatric information
  • 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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, 4.4 and 4.8 have been updated with information on paediatrics, in accordance with Article 45 of the paediatric regulation.

Updated on 22 August 2012

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration

Updated on 12 May 2011

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

In section 4.4 Special warnings and precautions for use, pulmonary toxicity in healthy donors has been added.

In section 4.8 Undesirable effects, information on side effects observed in normal donors undergoing peripheral blood progenitor cell mobilisation has been added.

The SmPC text has been revised in April 2011.

Updated on 10 May 2011

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 05 January 2011

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

Updated on 11 November 2010

Reasons for updating

  • New PIL for medicines.ie