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GENOTROPIN 5.3 mg powder and solvent for solution for injection.

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland Unlimited Company

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Somatropin

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

Updated on 17 October 2024

File name

Reg PIL GN 42_0 5.3_12mg TCC_Go Quick IE - clean.pdf

Reasons for updating

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

Updated on 16 October 2024

File name

Reg SPC GN 39_0 5.3mg IE - clean.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 30 May 2024

File name

Reg SPC GN 38_0 5.3mg IE clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

The SPC has been updated as follows:  Section 4.8 addition of ADR headache and the spelling of "Pruritus" is revised.

Updated on 30 May 2024

File name

Reg PIL GN 41_0 5.3_12mg TCC_Go Quick IE clean.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • 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 09 May 2024

File name

RegSPCGN3705.3mg IE clean.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

The SPC IS and SPC UK has been updated as follows:  to align with revised IFU including updates Section 6.3 replace '4 weeks' with '28 days' and removal of reference to the Genotropin Mixer in sections 6.5 and 6.6.

Updated on 09 May 2024

File name

RegPILGN4005.3_12mg TCC_Go Quick IE clean.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • 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

Updated on 10 January 2024

File name

RegPILGN3905.3_12mg TCC_Go Quick IE clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 29 June 2023

File name

Reg PIL GN 38_0 5.3_12mg TCC_Go Quick IE clean.pdf

Reasons for updating

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

Updated on 11 August 2022

File name

Reg SPC GN 36_0 5.3mg IE clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 11 August 2022

File name

Reg PIL GN 37_0 5.3_12mg TCC_Go Quick IE clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 27 October 2021

File name

Reg PIL GN 36_0 5.3_12mg TCC_Go Quick IE clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 27 October 2021

File name

Reg SPC GN 35_0 5.3mg IE clean.pdf

Reasons for updating

  • 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

The SPC has been updated as follows: Section 4.8 addition of adverse event Gynecomastia

The PIL to reflect the SPC changes

Updated on 01 October 2021

File name

DEC202163766_Reg SPC GN 34_0 5.3mg IE clean.pdf

Reasons for updating

  • 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

The SPC has been updated as follows: Section 4.3 addition of excipient warning text

Updated on 01 October 2021

File name

DEC202163766_Reg PIL GN 35_0 5.3_12mg TCC_Go Quick IE clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains

Updated on 09 September 2020

File name

DEC202059740_Reg SPC GN 32_0 5.3mg IE clean.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

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

Updated on 09 September 2020

File name

DEC202059740_Reg PIL GN 33_0 5.3_12mg TCC_Go Quick UK_IE clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 28 November 2018

File name

Reg SPC GN 29_0 5.3mg IE.pdf

Reasons for updating

  • Improved presentation of SPC

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

File name

Reg_SPC_GN_29_0_5.3mg_IE_clean.pdf

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

File name

Reg PIL GN 32_0 5.3_12mg TCC_Go Quick UK_IE clean.pdf

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

File name

Reg_SPC_GN_29_0_5.3mg_IE_clean.docx

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 08 May 2018

File name

Reg_SPC_GN_30_0_5.3mg_IE.clean.docx

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

Reasons for updating

  • New SPC for new product

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

Updated on 29 October 2014

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

Updates to:

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

File name

PIL_14800_978.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 October 2014

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

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision

Updated on 05 July 2013

Reasons for updating

  • Addition of joint PIL covering all presentations

Updated on 03 April 2012

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 2.QUALITATIVE AND QUANTITATIVE COMPOSITION,
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

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

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 21 November 2011

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

Reasons for updating

  • Change to marketing authorisation holder

Updated on 01 August 2011

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

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

SmPC – Changes to section 4.3 to 4.9 and section 10 of the SPC

Updated on 04 October 2010

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

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

SmPC: Changes to section 4.1 to 5.1 and 6.4, 6.5, 6.6 and section 10 of the SPC

Updated on 23 September 2010

Reasons for updating

  • New PIL for medicines.ie

Updated on 11 May 2009

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

Section 6.1 (List of excipients) has been updated to add E numbers to excipient names.

Updated on 18 December 2007

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

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

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 03 April 2007

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

 
Section 6.6 The heading has been changed to "Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product"
 
Section 6.6 Deleted references to the Jetex jet injection device.  This jet injection device is no longer manufactured and therefore it is desirable to remove references to it to minimize any confusion that may arise
 
Section 10 Date of revision of the text has been updated

Updated on 01 September 2006

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

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

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

Reasons for updating

  • New SPC for medicines.ie

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