Genotropin 12mg powder and solvent for solution for injection
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*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 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