Product class:
|
Authorized package
|
Medicinal product class:
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For human use
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Package code:
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1402906
|
Name of medicinal product:
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CERVARIX
|
Active substances:
|
Human papillomavirus vaccine (types 16, 18) recombinant, adjuvanted, adsorbed
Estonian,
English,
Latin
|
ATC code:
|
J07BM02
|
Dosage form:
|
suspension for injection in multidose container
|
Route of administration:
|
intramuscular use
|
Strengh:
|
1annus 0.5ml
|
Amount in package:
|
1ml 1TK
|
Legal status for supply*:
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Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant ano-genital
lesions (cervical, vulvar, vaginal and anal) and cervical and anal cancers causally related to certain
oncogenic Human Papillomavirus (HPV) types. See sections 4.4 and 5.1 for important information on
the data that support this indication.
The use of Cervarix should be in accordance with official recommendations.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
Glaxosmithkline Biologicals
|
Marketing authorization number:
|
EU/1/07/419
|
Marketing authorization issued on:
|
September 24, 2007
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Description
|
Additional condition
|
Ei ole lubatud väljastada korduvretsepti
|
|
Entry/Changing date:
March 27, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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