Phleum pratense pollen

Overview

Phleum pratense pollen allergenic extract is used in allergenic testing.

Indication

Phleum pratense pollen is an allergen extract included in an allergenic testing product called ORALAIR. It is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen38 specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age.

Associated Conditions

Allergic Rhinitis Due to Pollen

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
miRNA-155 Assay Before and After Immunotherapy and Probiotics	2020/10/26	NCT04603456	Phase 4	Completed	Zagazig University
The Impact of Grass SLIT Treatment on Birch Pollen Induced Allergic Rhinitis - a Pilot Evaluation	2015/03/20	NCT02394600	Phase 4	Completed	Queen's University
Efficacy and Safety of Grass Pollen Sublingual Immunotherapy	2007/12/04	NCT00567346	Phase 2	Completed	Artu Biologicals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Treatment Set TS346157	Antigen Laboratories, Inc.	49288-0854	SUBCUTANEOUS, INTRADERMAL	4000 [BAU] in 1 mL	5/11/2012
Treatment Set TS331632	Antigen Laboratories, Inc.	49288-0708	SUBCUTANEOUS, INTRADERMAL	3333.33 [BAU] in 1 mL	12/2/2009
Treatment Set TS331046	Antigen Laboratories, Inc.	49288-0704	SUBCUTANEOUS, INTRADERMAL	666.67 [BAU] in 1 mL	12/2/2009
Treatment Set TS330317	Antigen Laboratories, Inc.	49288-0684	SUBCUTANEOUS, INTRADERMAL	4000 [BAU] in 1 mL	12/2/2009
Treatment Set TS333938	Antigen Laboratories, Inc.	49288-0657	SUBCUTANEOUS, INTRADERMAL	454.5 [BAU] in 1 mL	12/2/2009
Treatment Set TS331977	Antigen Laboratories, Inc.	49288-0700	SUBCUTANEOUS, INTRADERMAL	16666.67 [BAU] in 1 mL	12/2/2009
Treatment Set TS333312	Antigen Laboratories, Inc.	49288-0667	INTRADERMAL, SUBCUTANEOUS	800 g in 1 mL	12/2/2009
Oralair 100 IR	Stallergenes	59617-0010	SUBLINGUAL	100 [IR] in 1 1	6/9/2025
Treatment Set TS339992	Antigen Laboratories, Inc.	49288-0804	INTRADERMAL, SUBCUTANEOUS	4000 [BAU] in 1 mL	3/15/2011
Treatment Set TS345883	Antigen Laboratories, Inc.	49288-0853	SUBCUTANEOUS, INTRADERMAL	800 [BAU] in 1 mL	5/11/2012

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

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
SOUTHERN GRASS MIX (1:20) Scratch test & treatment	32705	Stallergenes Australia Pty Ltd	Medicine	A	11/1/1991
Timothy Grass (1:20) Scratch test & treatment	32623	Stallergenes Australia Pty Ltd	Medicine	A	11/1/1991
ALUSTAL POLLEN EXTRACT OF FIVE GRASSES MAINTENANCE 10 IR/mL injection suspension vial	132847	Stallergenes Australia Pty Ltd	Medicine	A	10/3/2006
GRASS MIX #7 (1:20) Scratch test & treatment	32714	Stallergenes Australia Pty Ltd	Medicine	A	11/1/1991
ORALAIR Continuation Treatment Sublingual (Allergen pollen Extract of 5 grasses) Tablets 300IR blister pack	167566	Stallergenes Australia Pty Ltd	Medicine	A	5/3/2011
ALUSTAL POLLEN EXTRACT OF FIVE GRASSES INITIAL TREATMENT injection suspension vial composite pack	132848	Stallergenes Australia Pty Ltd	Medicine	A	10/3/2006
ORALAIR Initiation Treatment, Sublingual (Allergen pollen Extract of 5 grasses) Tablets 100IR & 300IR Blister Pack	167565	Stallergenes Australia Pty Ltd	Medicine	A	5/3/2011
Biochemics Hayfever	120022	Martin & Pleasance Pty Ltd	Medicine	A	6/22/2005
GRAZAX standardised allergen extract of grass pollen from Timothy grass (Phleum pratense) 75,000 SQ-T sublingual tablets blister foil	267955	Seqirus Pty Ltd	Medicine	A	3/7/2017

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ALLERGENIC EXTRACT - MIXTURE OF 5 STANDARDIZED GRASS POLLEN	alk-abello inc	02325543	Liquid - Subcutaneous , Percutaneous , Intradermal	20000 UNIT / ML	7/30/2009
STANDARDIZED GRASS POLLEN - TIMOTHY (10000 BAU/ML)	JUBILANT HOLLISTERSTIER LLC	02238498	Solution - Percutaneous , Subcutaneous	10000 UNIT / ML	9/26/2001
ALLERGENIC EXTRACTS - 7 GRASS MIX	greer laboratories inc	02425513	Liquid - Subcutaneous	100000 UNIT / ML	6/2/2014
PACIFIC GRASSES & WEED POLLEN VACCINE	bencard allergy laboratories, an allergy therapeutics (canada) ltd. company	00061441	Liquid - Subcutaneous	null NIL / NIL	12/31/1955
ALLERGENIC EXTRACT - STANDARDIZED GRASS POLLEN - TIMOTHY	greer laboratories inc	02242667	Liquid - Subcutaneous , Intracutaneous	10000 UNIT / ML	3/10/2015
ALLERGENIC EXTRACTS, K-O-R-T GRASS MIXTURE	greer laboratories inc	02447231	Solution - Intracutaneous , Subcutaneous	10000 UNIT / ML	N/A
ALLERGENIC EXTRACT - MIXTURE OF 4 STANDARDIZED GRASS POLLEN	alk-abello inc	02325535	Liquid - Intradermal , Percutaneous , Subcutaneous	25000 UNIT / ML	3/22/2011
STANDARDIZED GRASS POLLEN - TIMOTHY (1000 BAU/ML)	hollister-stier laboratories llc	02238499	Liquid - Intradermal	1000 UNIT / ML	N/A
STANDARDIZED GRASS POLLEN - TIMOTHY (100000 BAU/ML)	JUBILANT HOLLISTERSTIER LLC	02238497	Solution - Percutaneous , Subcutaneous	100000 UNIT / ML	12/5/2001
ALLERGENIC EXTRACT - STANDARDIZED TIMOTHY GRASS POLLEN	alk-abello inc	02325470	Liquid - Subcutaneous , Percutaneous , Intradermal	100000 UNIT / ML	7/30/2009

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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