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 May 25, 2023)
Package information leaflet (PIL): EST  (last updated May 25, 2023)
Labelling:  (last updated May 25, 2023)
Indication: [Nationally completed 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
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: 913916 
Marketing authorization issued on: September 13, 2016 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Assessment report:  (last updated September 13, 2016) 
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1696192  ALENDRONIC ACID/ COLECALCIFEROL SANDOZ  tablet  70mg +5600RÜ 2TK  Prescription           
1696204  ALENDRONIC ACID/ COLECALCIFEROL SANDOZ  tablet  70mg +5600RÜ 4TK  Prescription      11.09.2020     
1696215  ALENDRONIC ACID/ COLECALCIFEROL SANDOZ  tablet  70mg +5600RÜ 6TK  Prescription           
1696226  ALENDRONIC ACID/ COLECALCIFEROL SANDOZ  tablet  70mg +5600RÜ 12TK  Prescription      30.08.2019     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

You can download Acrobat Reader fromhere