Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1659416
Name of medicinal product: ADACEL
Active substances:
Estonian, English, Latin
ATC code: J07AX80
Dosage form: suspension for injection in pre-filled syringe
Route of administration: intramuscular use
Strengh: 0.5ml
Amount in package: 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: COVAXiS is indicated for: Active immunization against tetanus, diphtheria and pertussis in persons from 4 years of age as a booster following primary immunization. Passive protection against pertussis in early infancy following maternal immunization during pregnancy (see sections 4.2, 4.4, 4.6, and 5.1). COVAXiS should be used in accordance with official recommendations.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated June 30, 2022)
Package information leaflet (PIL): EST  (last updated June 30, 2022)
Labelling:  (last updated June 30, 2022)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Sanofi Pasteur 
Marketing authorization number: 912316 
Marketing authorization issued on: June 7, 2016 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Entry/Changing date: June 30, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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