Bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated)

Overview

Bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) is a vaccine that is used in the prophylaxis of Pertussis (whooping cough), which is caused by a small Gram-negative coccobacillus that infects the mucosal layers of the human respiratory tract.

Indication

No indication information available.

Associated Conditions

Pertussis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
KINRIX	GlaxoSmithKline Biologicals SA	58160-812	INTRAMUSCULAR	25 ug in 0.5 mL	11/26/2024
BOOSTRIX	A-S Medication Solutions	50090-1377	INTRAMUSCULAR	8 ug in 0.5 mL	3/31/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Hexyon	Sanofi Winthrop Industrie,82 Avenue Raspail,94250 Gentilly,France	Authorised	4/17/2013

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
PENTAXIM VACCINE	Sanofi Pasteur S.A., MLE, Sanofi Pasteur S.A., VDR	SIN14795P	INJECTION, POWDER, FOR SUSPENSION	25 μg/0.5 mL	6/5/2015
Tetraxim Vaccine	Sanofi Pasteur S.A., MLE, Sanofi Pasteur S.A., VDR	SIN15026P	INJECTION, SUSPENSION	25 μg/0.5ml	6/6/2016
ADACEL®-POLIO SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE	Sanofi Pasteur (VDR), SANOFI PASTEUR LIMITED	SIN15479P	INJECTION, SUSPENSION	2.5 µg/ 0.5 ml	5/8/2018
INFANRIX IPV+HIB VACCINE	GlaxoSmithKline Biologicals, GlaxoSmithKline Biologicals SA	SIN10988P	INJECTION	25mcg/0.5ml	6/25/1999
BOOSTRIX VACCINE	GlaxoSmithKline Biologicals, GlaxoSmithKline Biologicals SA	SIN11845P	INJECTION	8 mcg/0.5 ml	3/9/2002
HEXAXIM SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE	Sanofi Pasteur Val de Reuil	SIN14834P	INJECTION, SUSPENSION	25 μg/0.5 mL	8/25/2015
INFANRIX HEXA VACCINE	GLAXOSMITHKLINE BIOLOGICALS SA, GlaxoSmithKline Biologicals, GSK Biologicals SA	SIN12288P	INJECTION	25 mcg/0.5 ml	5/7/2003
BOOSTRIX POLIO SUSPENSION FOR INJECTION	GlaxoSmithKline Biologicals SAS	SIN15888P	INJECTION, SUSPENSION	8 mcg/0.5 ml	2/20/2020
Adacel®, Suspension for Injection	Sanofi Pasteur Ltd.	SIN14232P	INJECTION, SUSPENSION	2.5 micrograms	9/20/2012

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
HEXAXIM DTPa-hepB-IPV-Hib Suspension for injection in pre-filled syringe	215536	Sanofi-Aventis Australia Pty Ltd	Medicine	A	9/11/2014
TRIPACEL pertussis vaccine - acellular combined with diphtheria and tetanus toxoids (adsorbed)	63120	Sanofi-Aventis Australia Pty Ltd	Medicine	A	4/23/1998
INFANRIX-IPV 0.5mL injection syringe	159563	GlaxoSmithKline Australia Pty Ltd	Medicine	A	4/30/2009
ADACEL pertussis vaccine-acellular combined with diphtheria and tetanus toxoids (adsorbed) 0.5mL injection pre-filled needle-free syringe	297685	Sanofi-Aventis Australia Pty Ltd	Medicine	A	3/29/2018
INFANRIX HEXA injection composite pack (pre-filled syringe and vial)	132881	GlaxoSmithKline Australia Pty Ltd	Medicine	A	1/9/2007
QUADRACEL 0.5mL injection prefilled syringe	385069	Sanofi-Aventis Australia Pty Ltd	Medicine	A	5/24/2022
BOOSTRIX-IPV 0.5 mL injection syringe	96137	GlaxoSmithKline Australia Pty Ltd	Medicine	A	7/8/2004
VAXELIS DTPa5-HepB-IPV-Hib vaccine suspension for injection in 0.5 mL pre-filled syringe	363251	Maxx Pharma Pty Ltd	Medicine	A	3/23/2022
INFANRIX PENTA 0.5mL injection syringe	132883	GlaxoSmithKline Australia Pty Ltd	Medicine	A	1/8/2007
ADACEL POLIO pertussis vaccine - acellular diphtheria and tetanus toxoids (adsorbed) combined with inactivated poliovirus 0.5mL injection syringe	106576	Sanofi-Aventis Australia Pty Ltd	Medicine	A	6/6/2006

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
BOOSTRIX	GlaxoSmithKline Inc	02247600	Suspension - Intramuscular	8 MCG / 0.5 ML	5/29/2007
INFANRIX-IPV	GlaxoSmithKline Inc	02241284	Suspension - Intramuscular	25 MCG / 0.5 ML	10/25/2012
QUADRACEL	Sanofi Pasteur Limited	02534789	Suspension - Intramuscular	20 MCG / 0.5 ML	5/6/2024
PEDIACEL	Sanofi Pasteur Limited	02243167	Suspension - Intramuscular	20 MCG / 0.5 ML	10/4/2007
TRIPACEL HYBRID	Sanofi Pasteur Limited	02224143	Suspension - Intramuscular	20 MCG / 0.5 ML	1/23/1997
ADACEL	Sanofi Pasteur Limited	02240255	Suspension - Intramuscular	2.5 MCG / 0.5 ML	6/23/1999
PENTACEL	Sanofi Pasteur Limited	02534797	Suspension - Intramuscular	20 MCG / 0.5 ML	5/6/2024
ADACEL-POLIO	Sanofi Pasteur Limited	02352044	Suspension - Intramuscular	2.5 MCG / 0.5 ML	3/11/2011
QUADRACEL	Sanofi Pasteur Limited	02230946	Suspension - Intramuscular	20 MCG / 0.5 ML	6/20/1997
ACTACEL	Sanofi Pasteur Limited	02238683	Liquid - Intramuscular	10 MCG / 0.5 ML	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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