Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1709074
Name of medicinal product: ARMISARTE
Active substances:
Pemetrexed
Estonian, English, Latin
ATC code: L01BA04
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 25mg 1ml
Amount in package: 4ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Malignant pleural mesothelioma Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy na?ve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1). Pemetrexed is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5.1). Pemetrexed is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Actavis Group Ptc ehf. 
Marketing authorization number: EU/1/15/1063 
Marketing authorization issued on: January 21, 2016 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: September 10, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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