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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1243695
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Name of medicinal product:
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TYGACIL
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Active substances:
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|
ATC code:
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J01AA12
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Dosage form:
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powder for solution for infusion
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Route of administration:
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intravenous use
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Strengh:
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50mg
|
Amount in package:
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10TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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|
Additional information:
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Indication:
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Tygacil is indicated in adults and in children from the age of eight years for the treatment of the
following infections (see sections 4.4 and 5.1):
- Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections (see
section 4.4);
- Complicated intra-abdominal infections (cIAI).
Tygacil should be used only in situations where other alternative antibiotics are not suitable (see
sections 4.4, 4.8 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
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Labelling:
|
|
Last imported to Estonia:
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February 27, 2024
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Marketing authorization holder:
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Pfizer Europe MA EEIG
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Marketing authorization number:
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EU/1/06/336
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Marketing authorization issued on:
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April 24, 2006
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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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Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Description
|
Additional condition
|
Ei ole lubatud väljastada korduvretsepti
|
|
Hambaarstil on õigus välja kirjutada
|
|
Entry/Changing date:
October 3, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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