Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ARMISARTE
Active substances:
Pemetrexed
Estonian, English, Latin
ATC code: L01BA04
Dosage form: concentrate for solution for infusion
Strength: 25mg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
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 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1709074  ARMISARTE  concentrate for solution for infusion  25mg 1ml 4ml 1TK  Prescription           
1709085  ARMISARTE  concentrate for solution for infusion  25mg 1ml 20ml 1TK  Prescription           
1709096  ARMISARTE  concentrate for solution for infusion  25mg 1ml 40ml 1TK  Prescription           
1773895  ARMISARTE  concentrate for solution for infusion  25mg 1ml 34ml 1TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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