Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1364712
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Name of medicinal product:
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BRIDION
|
Active substances:
|
|
ATC code:
|
V03AB35
|
Dosage form:
|
solution for injection
|
Route of administration:
|
intravenous use
|
Strengh:
|
100mg 1ml
|
Amount in package:
|
5ml 10TK
|
Legal status for supply*:
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Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
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Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.
For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
May 12, 2021
|
Marketing authorization holder:
|
Merck Sharp & Dohme B.V.
|
Marketing authorization number:
|
EU/1/08/466
|
Marketing authorization issued on:
|
July 25, 2008
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
August 31, 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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