Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1678507
Name of medicinal product: METHOTREXATE ACCORD
Active substances:
Methotrexate
Estonian, English, Latin
ATC code: L01BA01
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use; intraarterial use; intramuscular use
Strengh: 100mg 1ml
Amount in package: 5ml 5TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Acute lymphocytic leukaemia, Non-Hodgkin’s lymphomas, osteogenic sarcoma, adjuvant and in advance disease of breast cancer, metastatic or recurrent head and neck cancer, choriocarcinoma and similar trophoblastic diseases, advanced cancer of urinary bladder.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated January 9, 2024)
Package information leaflet (PIL): EST  (last updated January 9, 2024)
Labelling:  (last updated November 3, 2021)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Accord Healthcare B.V. 
Marketing authorization number: 896215 
Marketing authorization issued on: December 10, 2015 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: April 4, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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