Dactylis glomerata pollen

Overview

Dactylis glomerata pollen is the pollen of the Dactylis glomerata plant. Dactylis glomerata pollen is mainly used in allergenic testing.

Indication

Dactylis glomerata 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 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
STANDARDIZED ORCHARD GRASS POLLEN	Allergy Laboratories, Inc.	54575-097	PERCUTANEOUS, SUBCUTANEOUS	100000 [BAU] in 1 mL	3/27/2010
Standardized Orchard Grass Pollen	Nelco Laboratories, Inc.	36987-2346	SUBCUTANEOUS, INTRADERMAL	10000 [BAU] in 1 mL	11/25/2009
Standardized Orchard Grass Pollen	Nelco Laboratories, Inc.	36987-2345	SUBCUTANEOUS, INTRADERMAL	100000 [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
Oralair 300 IR	Stallergenes	59617-0015	SUBLINGUAL	300 [IR] in 1 1	6/9/2025
Treatment Set TS333743	Antigen Laboratories, Inc.	49288-0681	SUBCUTANEOUS, INTRADERMAL	4000 [BAU] in 1 mL	12/2/2009
Treatment Set TS128811	Antigen Laboratories, Inc.	49288-0675	SUBCUTANEOUS, INTRADERMAL	1428.6 [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
SOUTHERN GRASS MIX (1:20) Scratch test & treatment	32705	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
Orchard Grass (1:20) Scratch test & treatment	32594	Stallergenes Australia Pty Ltd	Medicine	A	11/1/1991

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
ALLERGENIC EXTRACT - STANDARDIZED GRASS POLLEN - ORCHARD	greer laboratories inc	02242675	Liquid - Intracutaneous , Subcutaneous	10000 UNIT / ML	N/A
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
STANDARDIZED GRASS POLLEN - ORCHARD GRASS (1000 BAU/ML)	hollister-stier laboratories llc	02238487	Liquid - Intradermal	1000 UNIT / ML	N/A
ALLERGENIC EXTRACT - STANDARDIZED ORCHARD GRASS POLLEN	alk-abello inc	02325489	Liquid - Intradermal , Subcutaneous , Percutaneous	100000 UNIT / ML	7/30/2009
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 - ORCHARD GRASS (10000 BAU/ML)	JUBILANT HOLLISTERSTIER LLC	02238486	Solution - Subcutaneous , Percutaneous	10000 UNIT / ML	11/7/2000
STANDARDIZED GRASS POLLEN - ORCHARD GRASS (100000 BAU/ML)	JUBILANT HOLLISTERSTIER LLC	02238485	Solution - Percutaneous , Subcutaneous	100000 UNIT / ML	9/6/2000

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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