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Genotropin Miniquick 0.2mg,

*
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 38_0 MQ 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 32_0 MQ 0.2mg 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 31_0 MQ 0.2mg 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 37_0 MQ 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 10 January 2024

File name

RegPILGN360MQIEclean.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 35_0 MQ 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 30_0 MQ 0.2mg 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 34_0 MQ IE clean.pdf

Reasons for updating

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

Updated on 28 October 2021

File name

Reg PIL GN 33_0 MQ IE clean.pdf

Reasons for updating

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

Updated on 28 October 2021

File name

Reg SPC GN 29_0 MQ 0.2mg 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 28_0 MQ 0.2mg 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 32_0 MQ UK_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 26_0 MQ 0.2mg 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 30_0 MQ 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 23_0 MQ 0.2mg 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_23_0_MQ_0.2mg_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_23_0_MQ_0.2mg_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 29_0 MQ 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 10 May 2018

File name

Reg_SPC_GN_24_0_MQ_0.2mg_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 23 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 23 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

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_8847_741.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 02 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 30 March 2012

Reasons for updating

  • Change to, or new use for medicine
  • Change to storage instructions
  • Change to further information section
  • Change to date of revision

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 4.3 Contraindications 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

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 further information section
  • Change to date of revision

Updated on 04 October 2010

Reasons for updating

  • 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 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 4.3 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 23 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 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • 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, 6.6, 9 and section 10 of the SPC


Updated on 23 September 2010

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 12 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 05 May 2009

Reasons for updating

  • Change of manufacturer
  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information

Updated on 24 April 2008

Reasons for updating

  • Improved electronic presentation

Updated on 07 April 2008

Reasons for updating

  • 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

 

SPC

6.3 Shelf Life 24 months to 36 months

Updated on 02 April 2008

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Version GN_012 incorporates updates to SmPC sections 4.1 and 4.2 to an advice on the transition from paediatric to adult use and to update the dosing and administration schedules accordingly.

Updated on 18 December 2007

Reasons for updating

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

Updated on 29 November 2007

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 27 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 21 June 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 deletion of references to the Zip Tip device

Section 10 Update to the date of Partial revision of text

Updated on 21 June 2007

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 21 September 2006

Reasons for updating

  • Change of contraindications
  • Change to storage instructions

Updated on 04 September 2006

Reasons for updating

  • Change to packaging

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

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

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 7 - Marketing authorisation holder
  • 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 19 November 2004

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 04 November 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 30 June 2003

Reasons for updating

  • New SPC for medicines.ie

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