Bordetella pertussis pertactin antigen

Overview

Bordetella pertussis pertactin antigen is a vaccine for the prophylaxis of whooping cough that contains pertactin, a membrane-associated antigen of Bordetella pertussis .

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

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
Bacti Sode	Nutritional Specialties, Inc.	83027-0069	ORAL	30 [hp_X] in 1 mL	5/21/2025
Bacti Sode	Nutritional Specialties, Inc.	83027-0152	ORAL	30 [hp_X] in 1 mL	4/29/2025
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS PERTACTIN ANTIGEN, and BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN	A-S Medication Solutions	50090-1079	INTRAMUSCULAR	3 ug in 0.5 mL	10/22/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Infanrix Hexa	GlaxoSmithKline Biologicals S.A.,Rue de l'Institut, 89,B-1330 Rixensart,Belgium	Authorised	10/23/2000
Vaxelis	MCM Vaccine B.V.,Robert Boyleweg 4,2333 CG Leiden,Netherlands	Authorised	2/15/2016

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
ADACEL®-POLIO SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE	Sanofi Pasteur (VDR), SANOFI PASTEUR LIMITED	SIN15479P	INJECTION, SUSPENSION	3 µg/0.5 ml	5/8/2018
BOOSTRIX VACCINE	GlaxoSmithKline Biologicals, GlaxoSmithKline Biologicals SA	SIN11845P	INJECTION	2.5 mcg/0.5 ml	3/9/2002
INFANRIX HEXA VACCINE	GLAXOSMITHKLINE BIOLOGICALS SA, GlaxoSmithKline Biologicals, GSK Biologicals SA	SIN12288P	INJECTION	8 mcg/0.5 ml	5/7/2003
INFANRIX IPV+HIB VACCINE	GlaxoSmithKline Biologicals, GlaxoSmithKline Biologicals SA	SIN10988P	INJECTION	8mcg/0.5ml	6/25/1999
BOOSTRIX POLIO SUSPENSION FOR INJECTION	GlaxoSmithKline Biologicals SAS	SIN15888P	INJECTION, SUSPENSION	2.5 mcg/0.5 ml	2/20/2020
Adacel®, Suspension for Injection	Sanofi Pasteur Ltd.	SIN14232P	INJECTION, SUSPENSION	3 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
ADACEL POLIO VACCINE	N/A	Sanofi Hong Kong Limited	N/A	N/A	5/15/2008
BOOSTRIX VACCINE	N/A	葛兰素史克	N/A	N/A	8/8/2001
BOOSTRIX POLIO VACCINE	N/A	葛兰素史克	N/A	N/A	5/31/2007

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
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
BOOSTRIX 0.5 mL injection pre-filled syringe	158363	GlaxoSmithKline Australia Pty Ltd	Medicine	A	4/20/2009

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
BOOSTRIX	GlaxoSmithKline Inc	02247600	Suspension - Intramuscular	2.5 MCG / 0.5 ML	5/29/2007
INFANRIX-IPV	GlaxoSmithKline Inc	02241284	Suspension - Intramuscular	8 MCG / 0.5 ML	10/25/2012
QUADRACEL	Sanofi Pasteur Limited	02534789	Suspension - Intramuscular	3 MCG / 0.5 ML	5/6/2024
PEDIACEL	Sanofi Pasteur Limited	02243167	Suspension - Intramuscular	3 MCG / 0.5 ML	10/4/2007
BOOSTRIX-POLIO	GlaxoSmithKline Inc	02312557	Suspension - Intramuscular	2.5 MCG / 0.5 ML	10/22/2010
TRIPACEL HYBRID	Sanofi Pasteur Limited	02224143	Suspension - Intramuscular	3 MCG / 0.5 ML	1/23/1997
ADACEL	Sanofi Pasteur Limited	02240255	Suspension - Intramuscular	3 MCG / 0.5 ML	6/23/1999
PENTACEL	Sanofi Pasteur Limited	02534797	Suspension - Intramuscular	3 MCG / 0.5 ML	5/6/2024
ADACEL-POLIO	Sanofi Pasteur Limited	02352044	Suspension - Intramuscular	3 MCG / 0.5 ML	3/11/2011
QUADRACEL	Sanofi Pasteur Limited	02230946	Suspension - Intramuscular	3 MCG / 0.5 ML	6/20/1997

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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