GENOTROPIN 5.3 mg powder and solvent for solution for injection.
- Name:
GENOTROPIN 5.3 mg powder and solvent for solution for injection.
- Company:
Pfizer Healthcare Ireland
- 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: 28/06/18
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Pfizer Healthcare Ireland
Company Products
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 28 November 2018 SmPC
Reasons for updating
- Improved presentation of SmPC
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Improved presentation of SPC uploaded
Updated on 28 August 2018 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.4 – addition of Special warnings and precautions for use for Hypoadrenalism and Use with oral oestrogen therapy
Section 4.5 – addition of interaction information for Adrenocorticotropic hormone (ACTH) deficiency patients treated with glucocorticoids, decreases the conversion of cortisone to cortisol and women on oral oestrogen replacement.
Updated on 28 June 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 27 June 2018 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.4 – addition of Special warnings and precautions for use for Hypoadrenalism and Use with oral oestrogen therapy
Section 4.5 – addition of interaction information for Adrenocorticotropic hormone (ACTH) deficiency patients treated with glucocorticoids, decreases the conversion of cortisone to cortisol and women on oral oestrogen replacement.
Updated on 8 May 2018 SmPC
Reasons for updating
- 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
The SPC has been updated as follows: Section 5.1 the deletion of the last sentence in the paragraph within section 5.1 that provides information on clinical trials conducted in short children born SGA
Updated on 29 October 2014 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 29 October 2014 SmPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.3 - This has been updated in line with the CSP
Section 4.8 - This section has been updated in accordance with the CSP.
Updated on 22 October 2014 PIL
Reasons for updating
- New PIL for new product
Updated on 22 October 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 12 September 2013 PIL
Reasons for updating
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
Updated on 5 July 2013 PIL
Reasons for updating
- Addition of joint PIL covering all presentations
Updated on 3 April 2012 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.2 - Incompatibilities
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
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 for use,
Section 4.8 Undesirable effects,
Section 6.2 Incompatibilities,
Section 6.5 Nature and contents of container,
Section 6.6 Special precautions for disposal and other handling
Updated on 28 March 2012 SmPC
Reasons for updating
- Change to section 4.3 - Contraindications
- 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
SPC update to Section 4.3Contraindications and Section 4.4 Special warnings and precautions for use.
Updated on 27 March 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 21 November 2011 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SmPC MAH address change in section 7, PA number change section 8, Date of Authorisation section 9
Updated on 21 November 2011 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 1 August 2011 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 13 October 2010 SmPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
- Change to section 4.3 - Contraindications
- 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
Updated on 4 October 2010 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 24 September 2010 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5 - Pharmacological properties
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Updated on 23 September 2010 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 11 May 2009 SmPC
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 18 December 2007 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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
4.1 – Update to this section
4.2 - Update to this section
10 – Update to this section
Updated on 29 November 2007 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
4.2 – Update to this section
4.4 - deletion of current elderly statement by addition of new statement
4.5 – Update to spelling of cyclosprorin to ciclosporin
10 – Update to this section
Updated on 14 November 2007 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- 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
4.4 Change of m-cresol to metacresol
6.1 Change of excipient m-cresol to metacresol
10 - Change to date or Partial revision of text
Updated on 3 April 2007 SmPC
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Updated on 1 September 2006 SmPC
Reasons for updating
- Change to section 4.3 - Contraindications
- 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
- Change to section 6.3 - Shelf life
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Sections: 4.3, 4.4, 4.8 and 10 associated with the removal of a contraindication in PWS patients and the addition of post-marketing experiences.
AND section 6.3 the shelf life has been extended from 24 months to 36 months and the reconstituted shelf life of the 12mg presentation has changed to 4 weeks
Updated on 11 January 2006 SmPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 19 November 2004 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)