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Product class:
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Medicinal product with marketing authorization
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Medicinal product class:
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Human medicine
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Name of medicinal product:
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ACLASTA
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Active substances:
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|
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ATC code:
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M05BA08
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Dosage form:
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solution for infusion
|
|
Strength:
|
0,05mg 1ml
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Legal status for supply*:
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Subject to medicinal prescription
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Summary of product characteristics (SPC):
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Package information leaflet (PIL):
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EST
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Labelling:
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Indication:
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Treatment of osteoporosis
- in post-menopausal women
- in adult men
at increased risk of fracture, including those with a recent low-trauma hip fracture.
Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy
- in post-menopausal women
- in adult men
at increased risk of fracture.
Treatment of Paget¡¦s disease of the bone in adults.
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|
Safety features:
|
Yes
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Marketing authorization holder:
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Sandoz Pharmaceuticals d.d.
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Marketing authorization number:
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EU/1/05/308
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Marketing authorization issued on:
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April 5, 2005
|
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Centralised
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Assessment report:
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Package code
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Name of medicinal product
|
Dosage form
|
Package
|
Legal status
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Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
|
1201712
|
ACLASTA
|
solution for infusion
|
0,05mg 1ml 100ml 1TK
|
Prescription
|
|
|
22.11.2023
|
|
|
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1265666
|
ACLASTA
|
solution for infusion
|
0,05mg 1ml 100ml 5TK
|
Prescription
|
|
|
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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