Methotrexate 50 mg/2 ml 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 12 November 2024
File name
Reg PIL IE gxME 27_1 Inj 50mg-2ml clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 16 October 2024
File name
Reg PIL IE gxME 26_0 Inj 50mg-2ml 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 IE gxME 19_0 Inj 50mg-2ml 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 21 May 2024
File name
Reg SPC IE gxME 18_2 Inj 50mg-2ml clean.pdf
Reasons for updating
- Change to product name
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 May 2024
File name
Reg PIL IE gxME 24_2 Inj 50mg-2ml clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to name of medicinal product
Updated on 31 October 2023
File name
RegPILIEgxME230Inj50mg2mlclean.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 - manufacturer
- Change to section 6 - date of revision
Updated on 31 October 2023
File name
RegPILIEgxME230Inj50mg2mlclean.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 - manufacturer
- Change to section 6 - date of revision
Updated on 24 May 2023
File name
Reg SPC IEgx ME 17 1Inj 50mg 2ml clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 May 2023
File name
Reg PIL IE gx ME 22 1Inj 50mg 2ml 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 05 August 2022
File name
Reg SPC IE gxME 16_1 Inj 50mg 2ml clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 August 2022
File name
Reg PIL IE gxME 20_1 Inj 50mg 2ml clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 03 February 2022
File name
RegSPCIEgxME150Inj50mg2mlclean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
The SPC has been updated as follows:
Section 2 & 4.4 updated for the excipient sodium
Updated on 03 February 2022
File name
RegPILIEgxME190Inj50mg2mlclean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
Updated on 06 December 2021
File name
Reg SPC IE gxME 13_0 Inj 50mg-2ml clean new .pdf
Reasons for updating
- 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
The SPC has been updated as follows:
Update to section 4.4 regarding warning of progressive multifocal leukoencephalopathy (PML), as per PRAC recommended text.
Updated on 03 December 2021
File name
Reg SPC IE gxME 13_0 Inj 50mg-2ml clean.pdf
Reasons for updating
- 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
The SPC has been updated as follows:
Update to section 4.4 to add the warning of progressive multifocal leukoencephalopathy (PML) in line with PRAC recommended text.
Updated on 29 November 2021
File name
Reg PIL IE gxME 17_0 Inj 50mg-2ml 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 01 March 2021
File name
DEC202113658_Reg PIL IE gxME 16_0 Inj 50mg-2ml-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 September 2020
File name
Reg SPC IE gxME 12_1 Inj 50mg-2ml-clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 September 2020
File name
Reg PIL IE gxME 14_1 Inj 50mg-2ml-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 23 December 2019
File name
Reg PIL IE gxME 13_1 Inj 50mg-2ml_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - dose and frequency
- Change to section 6 - date of revision
Updated on 20 December 2019
File name
DEC201972132_Reg SPC IE gxME 11_2 Inj 50mg-2ml_clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 December 2019
File name
DEC201972132_Reg PIL IE gxME 12_1 Inj 50mg-2ml_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - dose and frequency
- Change to section 6 - date of revision
Updated on 14 November 2019
File name
Reg SPC gxME 10_1 Inj 50mg-2ml-c.pdf
Reasons for updating
- 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:
To update section 4.5 of the SmPC as per PRAC recommendations (EMEA/H/C/PSUSA/00002014/201810). To update the interaction of methotrexate with nitrous oxide
Updated on 14 November 2019
File name
Reg PIL IE gxME 12_1 Inj 50mg-2ml-c.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 6 - date of revision
Updated on 01 November 2018
File name
Reg PIL IE gxME 10_0 Inj 50mg-2ml_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 01 November 2018
File name
Reg SPC gxME 9_0 Inj 50mg-2ml_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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
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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Please update eMC / medicines.ie The SPC has been updated as per the PRAC recommendations. The following sections have been updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8 and 4.9
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Updated on 01 October 2018
File name
Reg SPC gxME 8_1 Inj 50mg-2ml_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 IE gxME 9_0 Inj 500mg-20ml_clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 28 September 2018
File name
Reg SPC gxME 8_1 Inj 50mg-2ml_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 18 September 2018
File name
Reg PIL IE gxME 8_0 Inj 50mg-2ml_clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 09 August 2018
File name
Reg SPC gxME 7_0 Inj 50mg-2ml_clean.pdf
Reasons for updating
- 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 impacted only.
Section 4.4 – updated to include reference to Thoracic pain.
Updated on 01 May 2018
File name
Reg_SPC_gx_ME_5_0_Inj_50mg_2ml_clean.docx
Reasons for updating
- 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
|
Section 4.4 and 4.8 updates with details of pulmonary alveolar haemorrhage Section 10- update date of revision of text to 04/2018 to reflect submission date and internal reference number updated. |
Updated on 26 April 2018
File name
Reg PIL IE gxME 5_0 Inj 50mg-2ml_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 section 6 - date of revision
Updated on 24 April 2018
File name
Reg_SPC_gxME_5_0_Inj_50mg_2ml_clean.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
|
Section 4.4 and 4.8 updates with details of pulmonary alveolar haemorrhage Section 10- update date of revision of text to 04/2018 to reflect submission date and internal reference number updated. |
Updated on 23 January 2018
File name
PIL_17061_156.pdf
Reasons for updating
- New PIL for new product
Updated on 23 January 2018
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 16 August 2017
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 19 January 2017
Reasons for updating
- New PIL for medicines.ie