SPEDRA

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

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 more about Avanafil

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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