SmPC - Methotrexate 25mg/ml solution for injection: Change history
View Summary of Product Characteristics (SmPC - 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).
SmPC sections updated: 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 6.3 & 10.
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).
SmPC sections updated: 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 6.3 & 10.
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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).
SmPC sections updated: 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 6.3 & 10.
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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)
SmPC sections updated: 4.6, 6.3 and 10.
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Changes: (Updated: 07 Feb 2023)
Change in ATC Code, update to a new Pharmacotherapeutic group, from Cytostatic agent: folic acid analogue to Folic acid analogues.
SmPC sections updated: 5.1, 10.
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Changes: (Updated: 20 Sep 2022)
Linked to amended product entry
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Changes: (Updated: 15 Sep 2022)
Initial upload