|
Product class:
|
Medicinal product with marketing authorization
|
|
Medicinal product class:
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Veterinary medicine
|
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Name of medicinal product:
|
Butasal-100
|
|
Active substances:
|
|
|
ATC code:
|
QA12CX92
|
|
Dosage form:
|
solution for injection
|
|
Strength:
|
100mg+0,05mg 1ml
|
|
Legal status for supply*:
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Subject to medicinal prescription
|
|
Summary of product characteristics (SPC):
|
 (last updated May 7, 2021)
|
|
Package information leaflet (PIL):
|
EST (last updated May 7, 2021)
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|
Labelling:
|
(last updated May 7, 2021)
|
|
Indication:
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As supportive treatment of metabolic or reproductive disorders.
In case of peri-parturient metabolic disorders, tetany and paresis (milk fever), the
product should be administered in addition to magnesium and calcium, respectively.
|
|
Safety features:
|
No
|
|
Marketing authorization holder:
|
Interchemie Werken De Adelaar Eesti aktsiaselts
|
|
Marketing authorization number:
|
2233
|
|
Marketing authorization issued on:
|
May 5, 2020
|
|
Marketing authorization expires on:
|
May 5, 2025
|
|
Marketing authorization procedure type:
|
Mutual recognition
|
|
Assessment report:
|
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
Additional information
|
|
1798724
|
Butasal-100
|
solution for injection
|
100mg +0,05mg 1ml 100ml 1TK
|
Prescription
|
|
|
31.03.2022
|
|
|
1814150
|
Butasal-100
|
solution for injection
|
100mg +0,05mg 1ml 100ml 6TK
|
Prescription
|
|
|
31.03.2022
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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