PIL - Methotrexate 25mg/ml Solution for Injection: Change history
View Patient Information Leaflet (PIL - Methotrexate 25mg/ml Solution for Injection)
Last updated on this site: 31 Mar 2025
1. To update sections 4.2, 4.4, 4.5, 4.6, 4.8 and 5.3 of the
SmPC and the PIL to be in-line with the product Information of
reference product Methotrexate 50mg/ 2ml Injection with
national procedure number: PA0822/206/002 & MAH: Pfizer
Ireland Limited.
2. To update sections 4.4 and 4.5 in SmPC and section 2 in
leaflet information in-line with the product Information of
reference product (Methotrexate 50mg/ 2ml Injection with
national procedure number: PA0822/206/002 & MAH: Pfizer
Ireland Limited).
3. To update sections 5.1 and 5.2 in SmPC in-line with the
product Information of reference product (Methotrexate 50mg/
2ml Injection with national procedure number: PA0822/206/002
& MAH: Pfizer Ireland Limited).
PIL sections updated: Sections: 2, 4, 6 and HCP section.
Last updated on this site: 31 Mar 2025
1. To update sections 4.2, 4.4, 4.5, 4.6, 4.8 and 5.3 of the
SmPC and the PIL to be in-line with the product Information of
reference product Methotrexate 50mg/ 2ml Injection with
national procedure number: PA0822/206/002 & MAH: Pfizer
Ireland Limited.
2. To update sections 4.4 and 4.5 in SmPC and section 2 in
leaflet information in-line with the product Information of
reference product (Methotrexate 50mg/ 2ml Injection with
national procedure number: PA0822/206/002 & MAH: Pfizer
Ireland Limited).
3. To update sections 5.1 and 5.2 in SmPC in-line with the
product Information of reference product (Methotrexate 50mg/
2ml Injection with national procedure number: PA0822/206/002
& MAH: Pfizer Ireland Limited).
PIL sections updated: Sections: 2, 4, 6 and HCP section.
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Changes: (Updated: 31 Mar 2025)
1. To update sections 4.2, 4.4, 4.5, 4.6, 4.8 and 5.3 of the
SmPC and the PIL to be in-line with the product Information of
reference product Methotrexate 50mg/ 2ml Injection with
national procedure number: PA0822/206/002 & MAH: Pfizer
Ireland Limited.
2. To update sections 4.4 and 4.5 in SmPC and section 2 in
leaflet information in-line with the product Information of
reference product (Methotrexate 50mg/ 2ml Injection with
national procedure number: PA0822/206/002 & MAH: Pfizer
Ireland Limited).
3. To update sections 5.1 and 5.2 in SmPC in-line with the
product Information of reference product (Methotrexate 50mg/
2ml Injection with national procedure number: PA0822/206/002
& MAH: Pfizer Ireland Limited).
PIL sections updated: Sections: 2, 4, 6 and HCP section.
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Changes: (Updated: 07 Jan 2025)
To update sections 4.4, 4.6, 4.8 & 5.1 of the SmPC to include photosensitivity as a side effect of methotrexate treatment following advice from MHRA. Consequently sections 2 & 4 of the PIL is also being updated. Additionally, section 6.3 of the SmPC is being updated for PL 20075/0344 only, to align information with the PIL.
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Changes: (Updated: 26 Oct 2023)
Description of update: Update to product information in-line with the agreed wording of PSUFU (DE/H/PSUFU/00002014/202110)
PIL sections updated: 2 and 6.
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Changes: (Updated: 20 Sep 2022)
Linked to amended product entry
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Changes: (Updated: 15 Sep 2022)
Added document ID
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Changes: (Updated: 12 Sep 2022)
Initial upload