Lolium perenne pollen

Overview

Lolium perenne pollen is the pollen of the Lolium perenne plant. Lolium perenne pollen is mainly used in allergenic testing.

Indication

Lolium perenne 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

No clinical trials found

No clinical trials found for this drug

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Treatment Set TS340826	Antigen Laboratories, Inc.	49288-0812	INTRADERMAL, SUBCUTANEOUS	4761.9 [BAU] in 1 mL	3/30/2011
STANDARDIZED PERENNIAL RYEGRASS GRASS POLLEN	Allergy Laboratories, Inc.	54575-102	PERCUTANEOUS, SUBCUTANEOUS	100000 [BAU] in 1 mL	3/27/2010
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
Oralair 100 IR	Stallergenes	59617-0010	SUBLINGUAL	100 [IR] in 1 1	6/9/2025
Treatment Set TS341824	Antigen Laboratories, Inc.	49288-0818	SUBCUTANEOUS, INTRADERMAL	5882 [BAU] in 1 mL	6/8/2011
Treatment Set TS330171	Antigen Laboratories, Inc.	49288-0725	SUBCUTANEOUS, INTRADERMAL	800 [BAU] in 1 mL	12/2/2009
Standardized Perennial Rye Grass Pollen	Nelco Laboratories, Inc.	36987-2390	SUBCUTANEOUS, INTRADERMAL	10000 [BAU] in 1 mL	11/25/2009
Treatment Set TS333519	Antigen Laboratories, Inc.	49288-0680	SUBCUTANEOUS, INTRADERMAL	4000 [BAU] in 1 mL	12/2/2009
Treatment Set TS331657	Antigen Laboratories, Inc.	49288-0679	SUBCUTANEOUS, INTRADERMAL	4000 [BAU] in 1 mL	12/2/2009

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
Perennial Ryegrass (1:20) Scratch test & treatment	32607	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

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
STANDARDIZED GRASS POLLEN - PERENNIAL RYEGRASS (100000 BAU/ML)	JUBILANT HOLLISTERSTIER LLC	02238501	Solution - Subcutaneous , Percutaneous	100000 UNIT / ML	12/5/2000
ALLERGENIC EXTRACTS - 7 GRASS MIX	greer laboratories inc	02425513	Liquid - Subcutaneous	100000 UNIT / ML	6/2/2014
ALLERGENIC EXTRACT - STANDARDIZED GRASS POLLEN - PERENNIAL RYE	greer laboratories inc	02242677	Liquid - Intracutaneous , Subcutaneous	10000 UNIT / ML	10/14/2015
ALLERGENIC EXTRACT - STANDARDIZED PERENNNIAL RYE GRASS POLLEN	alk-abello inc	02325500	Liquid - Percutaneous , Intradermal , Subcutaneous	100000 UNIT / ML	7/30/2009
STANDARDIZED GRASS POLLEN - PERENNIAL RYEGRASS (10000 BAU/ML)	JUBILANT HOLLISTERSTIER LLC	02238502	Solution - Subcutaneous , Percutaneous	10000 UNIT / ML	8/29/2000
ALLERGENIC EXTRACTS - 7 GRASS MIX	greer laboratories inc	02425505	Liquid - Subcutaneous	10000 UNIT / ML	9/25/2014
STANDARDIZED GRASS POLLEN - PERENNIAL RYEGRASS (1000 BAU/ML)	hollister-stier laboratories llc	02238503	Liquid - Intradermal	1000 UNIT / ML	N/A
STANDARDIZED GRASS POLLEN - PERENNIAL RYEGRASS (100 BAU/ML)	hollister-stier laboratories llc	02238504	Liquid - Intradermal	100 UNIT / ML	N/A
ALLERGENIC EXTRACT - STANDARDIZED GRASS POLLEN - PERENNIAL RYE	greer laboratories inc	02242676	Liquid - Subcutaneous , Intracutaneous	100000 UNIT / ML	10/30/2000

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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