Methotrexate 2.5 mg Tablets
*Company:
ADVANZ PharmaStatus:
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 04 February 2025
File name
Methotrexate 2.5 mg Tablets_PIL.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 04 February 2025
File name
Methotrexate 2.5 mg Tablets_SPC.pdf
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 July 2024
File name
1.3.1 PIL-Generic-Haupt Amareg-2.5mg-IE-Eng-clean-0049.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
File name
Direct Healthcare Professional Communication_Methotrexate.pdf
Reasons for updating
- Add New Doc
File name
7. Methotrexate Patient Alert Card- Final.pdf
Reasons for updating
- Add New Doc
File name
3. Methotrexate Cover Letter Community Pharmacist_Final.pdf
Reasons for updating
- Add New Doc
File name
1. Methotrexate Cover Letter Hospital Pharmacist_Final.pdf
Reasons for updating
- Add New Doc
File name
3. Methotrexate Cover Letter Community Pharmacist_Final.pdf
Reasons for updating
- Add New Doc
File name
4. Methotrexate Checklist for Community Pharmacists_Final.pdf
Reasons for updating
- Add New Doc
File name
5. Methotrexate Cover Letter Physician_Final.pdf
Reasons for updating
- Add New Doc
File name
6. Methotrexate Checklist for Physicians_Final.pdf
Reasons for updating
- Add New Doc
File name
2. Methotrexate Checklist for Hospital Pharmacists_Final.pdf
Reasons for updating
- Add New Doc
Updated on 04 April 2023
File name
Methotrexate sodium Tablet 2.5 mg_PIL.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 6 - date of revision
Updated on 04 April 2023
File name
Methotrexate sodium Tablet 2.5 mg_SPC.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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 04 April 2023
File name
Methotrexate sodium Tablet 2.5 mg_SPC_IE.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 January 2022
File name
Methotrexate sodium Tablet 2.5 mg_SPC_IE.pdf
Reasons for updating
- Change due to harmonisation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Description of Change: Type II, Category C.I..z variation to update the SmPC and PIL of Methotrexate 2.5mg Tablets in line with the reference product; Maxtrex 2.5 mg Tablets by Pfizer Limited.
Updated on 14 January 2022
File name
Methotrexate sodium Tablet 2.5 mg_PIL_IE.pdf
Reasons for updating
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Description of Change: Type II, Category C.I..z variation to update the SmPC and PIL of Methotrexate 2.5mg Tablets in line with the reference product; Maxtrex 2.5 mg Tablets by Pfizer Limited.
Updated on 30 December 2021
File name
Methotrexate 2.5 mg tablets_SPC_IE.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 December 2021
File name
Methotrexate 2.5 mg tablets_PIL_IE.pdf
Reasons for updating
- New PIL for new product
Updated on 14 February 2020
File name
1.3.1 - SmPC - 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)
Free text change information supplied by the pharmaceutical company
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Type IAIN, Category C.I.z (As per Article 5 of Commission Regulation (EC) No 1234/2008) application to update SmPC and PIL as per PRAC (Pharmacovigilance Risk Assessment Committee) recommendation on Methotrexate, adopted by the Committee for Medicinal Products for Human Use (CHMP) at its meeting of July 2019. |
Updated on 11 April 2019
File name
Methotrexate 2.5mg tablets.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)