Glyceryl Trinitrate 5 mg/ml Sterile Concentrate
*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 gxGY 13_0 IE_clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The PIL has been updated to reflect the SPC change for the MAH name and address.
Updated on 17 October 2024
File name
Reg SPC gxGY 7_0 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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 7 Change of MAH name and address.
Updated on 17 April 2024
File name
Reg PIL gx GY 12 0 IE clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 29 November 2023
File name
Reg PIL gx GY 11 0 IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 July 2022
File name
Reg PIL gxGY 10_1 IE_clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 03 May 2022
File name
RegSPCgxGY64IEclean.pdf
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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
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The SPC has been updated as follows:
Section 4.2 – Repositioning of some dosage information and removal of dosage table; addition of information on hepatic / renal impairment.
Section 4.3 – Rewording of hypotensive shock contraindication.
Section 4.4 – Repositioning of some warnings; addition of information on severe hypotension.
Section 4.5 – Addition of interaction with heparin.
Section 4.8 – Updates to wording in adverse reactions table.
Section 4.9 – Addition of sub-headings and information on treatment.
Section 6.6 – Addition of information of mixing under aseptic conditions.
Section 10 – Update to date of revision.
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Updated on 03 May 2022
File name
RegPILgxGY93IEclean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 23 July 2021
File name
Reg PIL gxGY 8_0 IE_clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 30 April 2021
File name
DEC202129165_Reg PIL gxGY 7_0 IE clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 15 January 2021
File name
DEC202103116_Reg SPC gxGY 5_2 IE_clean.pdf
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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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)
Updated on 15 January 2021
File name
DEC202103116_Reg PIL gxGY 6_1 IE_clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 16 January 2019
File name
DEC201901966_Reg PIL gxGY 4_0 IE_clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
Updated on 16 January 2019
File name
DEC201901966_Reg SPC gxGY 3_1 IE_clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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 has been updated as follows:
Section 2 – Addition of information on excipient with known effect
Sections 3, 4.2, 4.3, 4.8, 5.1, 5.2, 6.2, 6.3, 6.4, 6.6 – updated in line with QRD v10.
Updated on 31 October 2018
File name
Reg PIL gxGY 3_0 IE_clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 05 October 2018
File name
Reg PIL gxGY 2_0 IE_clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 05 October 2018
File name
Reg SPC gxGY 2_0 IE_clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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The SPC has been updated as follows: Section 7 has been updated from Current MAH to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number. |
Updated on 27 April 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 April 2017
File name
PIL_17128_561.pdf
Reasons for updating
- New PIL for new product
Updated on 27 April 2017
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 27 April 2017
Reasons for updating
- 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
Free text change information supplied by the pharmaceutical company
Updated on 23 March 2017
Reasons for updating
- New SPC for medicines.ie
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 March 2017
Reasons for updating
- New SPC for medicines.ie