Methotrexate 2.5mg Tablets
Product Information *
Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateActive Ingredients :
*Additional information is available upon request
Legal Category:
Product subject to medical prescription which may not be renewed (A)
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 09 February 2021
File name
DEC202108365_Reg PIL gxME 10_0 2.5mg IE - clean_1612856889.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 10_1 2.5mg-clean_1601284682.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 SPC IE gxME 10_1 2.5mg-clean_1601284588.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 gxME 9_1 2.5mg IE-clean_1601284535.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 9_2 2.5mg_clean_1576854093.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 gxME 8_2 2.5mg IE_clean_1576854012.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 01 November 2018
File name
Reg PIL gxME 7_0 2.5mg IE_clean_1541060267.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 8_0 2.5mg IE_clean_1541060410.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)
Updated on 01 October 2018
File name
Reg SPC gxME 7_1 2.5mg IE_clean_1538140956_1538391559.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 gxME 6_1 2.5mg IE_clean_1538141787.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 28 September 2018
File name
Reg SPC gxME 7_1 2.5mg IE_clean_1538140956.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 09 August 2018
File name
Reg SPC gxME 6_0 2.5mg IE_clean_1533803222.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_gxME_4_0_2.5mg_IE_clean.docx
Reasons for updating
- Other
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 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 30 April 2018
File name
Reg_SPC_gxME_4_0_2.5mg_IE_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
|
Please update eMC / medicines.ie 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 gxME 4_0 2.5mg 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 section 6 - date of revision
Updated on 07 December 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 December 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
- 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 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 to align with Orion CSI. The following sections are updated: Sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 6.6 and 10 |
Updated on 05 December 2017
Reasons for updating
- 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 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 05 December 2017
File name
PIL_17033_65.pdf
Reasons for updating
- New PIL for new product
Updated on 27 July 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Updated on 26 July 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - marketing authorisation holder
Updated on 04 July 2017
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
HPRA on 17 May 2017 was approved for Methotrexate 2.5mg and 10mg tablets.
This submission included modifications to the SPC and consequently PIL to include details of methotrexate and nitrous oxide interaction. This was approved with
no deficiencies.Updated on 29 June 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - dose and frequency
- Change to section 6 - date of revision
Updated on 05 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 04 January 2017
Reasons for updating
- New PIL for medicines.ie