Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1695056
Name of medicinal product: ALENDRONIC ACID/COLECALCIFEROL ZENTIVA
Active substances:
Alendronic acid+Colecalciferol
Estonian, English, Latin
ATC code: M05BB03
Dosage form: tablet
Route of administration: oral use
Strengh: 70mg+5600RÜ
Amount in package: 2TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: [Invented name] is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency. It reduces the risk of vertebral and hip fractures.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated March 1, 2023)
Package information leaflet (PIL): EST  (last updated March 1, 2023)
Labelling:  (last updated June 6, 2022)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Zentiva k.s. 
Marketing authorization number: 940917 
Marketing authorization issued on: June 6, 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: December 20, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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