Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Active substances:
Alendronic acid+Colecalciferol
Estonian, English, Latin
ATC code: M05BB03
Dosage form: tablet
Strength: 70mg+5600RÜ
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated September 28, 2021)
Package information leaflet (PIL): EST  (last updated September 28, 2021)
Labelling:  (last updated September 28, 2021)
Indication: is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency. reduces the risk of vertebral and hip fractures.
Safety features: Yes
Marketing authorization holder: Mylan Pharmaceuticals Limited 
Marketing authorization number: 975018 
Marketing authorization issued on: December 5, 2018 
Marketing authorization expires on: November 7, 2024 
Marketing authorization procedure type: Decentralised 
Assessment report:  (last updated December 5, 2018) 
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1742059  ALENDRONIC ACID/COLECALCIFEROL MYLAN  tablet  70mg +5600RÜ 4TK  Prescription           
1742060  ALENDRONIC ACID/COLECALCIFEROL MYLAN  tablet  70mg +5600RÜ 12TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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