Methotrexate 1 g/10 ml 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 16 October 2024
File name
Reg SPC IE gxME 19_0 Inj 1g-10ml 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 IE gxME 24_0 Inj 1g-10ml & 5g-50 ml clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 29 April 2024
File name
Reg PIL IE gxME23 1Inj 1g 10ml 5g 50ml clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 29 April 2024
File name
Reg SPC IE gxME18 1Inj 1g 10ml 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 25 October 2023
File name
RegPILIEgxME220Inj1g10ml5g50mlclean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 June 2023
File name
Reg SPC IE gxME 17_1 Inj 1g 10ml clean.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 May 2023
File name
Reg SPC IE gxME 16 1Inj 1g 10ml 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 gxME 211 Inj 1g 10ml 5g 50ml 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 15 March 2023
File name
Reg PIL IE gxME191 Inj 1g 10ml 5g 50ml clean.pdf
Reasons for updating
- 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 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 05 August 2022
File name
Reg SPC IE gxME 15_1 Inj 1g 10ml 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 18_1 Inj 1g 10ml 5g 50ml 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
RegSPCIEgxME140Inj1g10mlclean.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
RegPILIEgxME170Inj1g10ml5g5mlclean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
Updated on 29 November 2021
File name
Reg SPC IE gxME 12_0 Inj 1g-10ml 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 15_0 Inj 1g-10ml & 5g-5 ml 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 14_0 Inj 1g-10ml & 5g-5 ml-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 11_1 Inj 1g-10ml-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 12_1 Inj 1g-10ml & 5g-5 ml-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 20 December 2019
File name
DEC201972132_Reg SPC IE gxME 10_2 Inj 1g-10ml_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 11_1 Inj 1g-10ml & 5g-5 ml_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 IE gxME 9_1 Inj 1g-10ml-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 10_1 Inj 1g-10ml 5g-5 ml-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 8_0 Inj 1g-10ml & 5g-5 ml_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 IE gxME 7_0 Inj 1g-10ml_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
|
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
|
Updated on 01 October 2018
File name
Reg SPC IE gxME 6_1 Inj 1g-10ml_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 7_0 Inj 1g-10ml 5g-5 ml_clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 28 September 2018
File name
Reg SPC IE gxME 6_1 Inj 1g-10ml_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 6_0 Inj 1g-10ml & 5g-5 ml_clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 09 August 2018
File name
Reg SPC IE gxME 5_0 Inj 1g-10ml_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 14 May 2018
File name
Reg_SPC_IE_gxME_3_0_Inj_1g-10ml_clean.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 April 2018
File name
Reg PIL IE gxME 3_0 Inj 1g-10ml & 5g-5 ml_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_IE_gxME_3_0_Inj_1g-10ml_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 23 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 February 2018
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
|
Please update eMC / medicines.ie Section 7 – Marketing Authorisation Holder – address updated. Section 10 – Date of revision of text updated to 02/2018 and Reference number updated. |
Updated on 21 February 2018
File name
PIL_17058_832.pdf
Reasons for updating
- New PIL for new product
Updated on 21 February 2018
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 25 January 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 19 January 2017
Reasons for updating
- New PIL for medicines.ie