SPEDRA

This brand name is authorized in Austria, Australia, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom

Active ingredients

The drug SPEDRA contains one active pharmaceutical ingredient (API):

1 Avanafil UNII DR5S136IVO - AVANAFIL

Avanafil is a highly selective and potent, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5. When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by avanafil produces increased levels of cGMP in the corpus cavernosum of the penis. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Read about Avanafil

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
SPEDRA Tablet	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
G04BE10		G Genito urinary system and sex hormones → G04 Urologicals → G04B Other urologicals, incl. antispasmodics → G04BE Drugs used in erectile dysfunction
Discover more medicines within G04BE10

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 11837B, 11860F, 11861G
Country: EE	Ravimiamet	Identifier(s): 1619186, 1619197, 1619209, 1619210, 1619221, 1619232, 1619243, 1628805, 1628816, 1628827, 1735657
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 113841001, 113841002, 113841004, 113841005, 113841006, 113841008, 113841009
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 128240, 177206, 395953, 412417, 515398, 561154
Country: FR	Base de données publique des médicaments	Identifier(s): 63294049, 66839572, 68366495
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 243961, 243963, 243967, 243968, 243972, 243973
Country: HK	Department of Health Drug Office	Identifier(s): 65087, 65088, 65089
Country: IT	Agenzia del Farmaco	Identifier(s): 042876019, 042876021, 042876033, 042876045, 042876058, 042876060, 042876072, 042876084, 042876096, 042876108, 042876110, 042876122, 042876134, 042876146, 042876159, 042876161, 042876173, 042876185, 042876197, 042876209, 042876211, 042876223
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1070762, 1070763, 1070764, 1070765, 1070766, 1070767, 1070768, 1070769, 1070770, 1070771, 1081293, 1091798, 1091799, 1091801, 1091802, 1091803, 1091804, 1091805, 1091806, 1091807, 1091808, 1091809
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 115142, 115150, 115169
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 16917, 16918, 16922
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100307942, 100307959, 100307965
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W60280001, W60280002, W60280003, W60280004, W60280005, W60280006, W60281001, W60281002, W60281003, W60281004, W60281005, W60281006, W60281007, W60281008, W60282001, W60282002, W60282003, W60282004, W60282005, W60282006, W60282007