GRANOCYTE 13 million IU/mL, powder and solvent for solution for injection/infusion in a pre-filled syringe
- Name:
GRANOCYTE 13 million IU/mL, powder and solvent for solution for injection/infusion in a pre-filled syringe
- Company:
Chugai Pharma France S.A.S.
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/04/19
(Click to Download) Summary of Product Characteristics last updated on medicines.ie: 16/4/2019
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Chugai Pharma France S.A.S.
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name GRANOCYTE 13 million IU/mL, powder and solvent for solution for injection/infusion in a pre-filled syringe | Active Ingredients Lenograstim |
| Medicine Name GRANOCYTE 34 million IU/mL, powder and solvent for solution for injection/infusion in a pre-filled syringe | Active Ingredients Lenograstim |
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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 16 April 2019 PIL
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 SmPC
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 4 March 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 4 March 2019 SmPC
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 PIL
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 PIL
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 SmPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 24 January 2018 SmPC
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
- 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 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 24 January 2018 PIL
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 2 October 2015 SmPC
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 1 October 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 1 December 2014 SmPC
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.
In section 10, the date of revision is now November 2014.
Updated on 15 October 2014 PIL
Reasons for updating
- Improved electronic presentation
Updated on 12 September 2014 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 12 March 2014 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 12 March 2014 SmPC
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.
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 6 September 2013 PIL
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 5 September 2013 SmPC
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.
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 SmPC
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 SmPC
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 PIL
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 SmPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 5 January 2011 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
Updated on 11 November 2010 PIL
Reasons for updating
- New PIL for medicines.ie