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Intended for UK patients and members of the public

Methotrexate Solution

Active Ingredients

Product Documentation

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Methotrexate 25mg/ml solution for injection

PL Number:
20075/0344
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • 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.

  • 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

General FAQs

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