Tobramycin 40 mg/ml Solution for Injection
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
No Recent UpdateLegal 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 16 October 2024
File name
Reg SPC IE gxTO 8_0 40mg-ml 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 16 October 2024
File name
Reg PIL gxTO 13_0 40mg-ml IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 17 October 2023
File name
RegPILgxTO12040mgmlIEclean.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 07 September 2023
File name
Reg PIL gx TO 11_0 40 mg ml IE clean.PDF
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 24 August 2022
File name
CleanSPC .pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
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:
- Update to sections 4.6 Fertility, pregnancy and lactation of the Summary of Product Characteristics (SmPC) in line with the CSI.
- Update to section 4.8 to update the UK reporting of adverse reactions.
Updated on 24 August 2022
File name
CleanPIL.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 20 January 2022
File name
Reg SPC IE gxTO 7_1 40mg-ml IE clean.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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- 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
|
The SPC has been updated as follows:
Updates to the following sections: 4.3 Contraindications 4.4 Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction 4.7 Effects on ability to drive and use machines 4.8 Undesirable effects 4.9 Overdose 5.2 Pharmacokinetic properties 6.6 Special precautions for disposal and other handling 10. Date of Revision of the Text |
Updated on 20 January 2022
File name
Reg PIL gxTO 9_2 40mg-ml IE clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to information for healthcare professionals
Updated on 01 October 2021
File name
DEC202163555_Reg SPC IE gxTO 6_1 40mg-ml IE clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
|
The SPC has been updated as follows: Section 4.4: Addition of waring concerning mitochondrial DNA mutations Section 10: Date of Revision |
Updated on 01 October 2021
File name
DEC202163555_Reg PIL gxTO 8_1 40mg-ml 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 22 February 2021
File name
DEC202081130_Reg SPC IE gxTO 4_1 40mg-ml 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 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 February 2021
File name
DEC202109816_Reg PIL gxTO 7_0 40mg-ml IE_clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 03 December 2020
File name
DEC202081130_Reg SPC IE gxTO 4_1 40mg-ml 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 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 December 2020
File name
DEC202081130_Reg PIL gxTO 6_1 40mg-ml IE_clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 29 May 2020
File name
DEC202035829_Reg PIL gxTO 5_1 40mg-ml IE_clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 28 May 2020
File name
DEC202035117_Reg PIL gxTO 5_1 40mg-ml IE_clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 24 December 2019
File name
DEC201972979_Reg PIL gxTO 4_1 40mg-ml IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 14 December 2018
File name
DEC201820779_Reg SPC IE gxTO 3_0 40mg-ml IE-clean.pdf
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 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 4.6 - 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 7 - Marketing authorisation holder
- Change to section 4 - Clinical particulars
- Change to section 5 - Pharmacological properties
- Change to section 6 - Pharmaceutical particulars
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: The following SPC sections have been updated in line with the QRD v10 template: sections 1, 2, 3, 4, 4.1, 4.2, 4.3, 4.4, 4.6, 4.7 4.8, 5, 5.1, 5.2, 6, 6.2, 6.4, 6.6 and 7.
Updated on 05 November 2018
File name
Reg PIL gxTO 3_0 40mg-ml IE-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 01 October 2018
File name
Reg SPC gxTO 2_0 40mg-ml 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
|
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 28 September 2018
File name
Reg PIL gxTO 2_0 40mg-ml IE-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 28 September 2018
File name
Reg SPC gxTO 2_0 40mg-ml 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 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 01 June 2018
File name
Reg PIL gxTO 1_7 40mg-ml IE clean.pdf
Reasons for updating
- New PIL for new product
Updated on 09 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)