Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1742059
Name of medicinal product: ALENDRONIC ACID/COLECALCIFEROL MYLAN
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: 4TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
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)
Last imported to Estonia: Never imported to Estonia
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: November 7, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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