Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1119798
Name of medicinal product: METHOTREXATE EBEWE 100 MG/ML
Active substances:
Methotrexate
Estonian, English, Latin
ATC code: L01BA01
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 100mg 1ml
Amount in package: 5ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Methotrexate is indicated in the treatment of different malignant diseases such as acute lymphatic leukaemia (ALL), breast cancer and osteosarcoma.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated June 29, 2023)
Package information leaflet (PIL): EST  (last updated June 29, 2023)
Labelling:  (last updated November 27, 2018)
Last imported to Estonia: February 15, 2012
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: 668310 
Marketing authorization issued on: February 3, 2010 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: November 2, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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