Genotropin 12mg powder and solvent for solution for injection

*
Pharmacy Only: Prescription

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 12mg 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 12mg 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

RegSPCGN37012mgIEclean.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

RegSPCGN37012mgIEclean.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 12mg 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 12mg 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 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 01 October 2021

File name

DEC202163766_Reg SPC GN 34_0 12mg 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 09 September 2020

File name

DEC202059740_Reg SPC GN 32_0 12mg 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 12mg 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_12mg_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 27 June 2018

File name

Reg_SPC_GN_29_0_12mg_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 27 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 08 May 2018

File name

Reg_SPC_GN_30_0_12mg_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 22 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 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 27 March 2012

Reasons for updating

  • Change to warnings or special precautions for use

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 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 23 September 2010

Reasons for updating

  • New PIL for medicines.ie