REVATIO

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.

Active ingredients

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

1	Sildenafil UNII BW9B0ZE037 - SILDENAFIL CITRATE
	Sildenafil is a potent and selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5), the enzyme that is responsible for degradation of cGMP. Apart from the presence of this enzyme in the corpus cavernosum of the penis, PDE5 is also present in the pulmonary vasculature. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation.
	Read more about Sildenafil

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
REVATIO Film-coated tablet	MPI, EU: SmPC	European Medicines Agency (EU)
REVATIO Solution for injection	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
C02KX	Antihypertensives for pulmonary arterial hypertension	C Cardiovascular system → C02 Antihypertensives → C02K Other antihypertensives
Discover more medicines within C02KX
G04BE03	Sildenafil	G Genito urinary system and sex hormones → G04 Urologicals → G04B Other urologicals, incl. antispasmodics → G04BE Drugs used in erectile dysfunction
Discover more medicines within G04BE03

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	12138W, 12144E, 9547L, 9605M
BR	Câmara de Regulação do Mercado de Medicamentos	552820090070117
CA	Health Products and Food Branch	02279401, 02341611
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00021551, 00164871, 01055434, 03719186, 04572704, 05489810, 05500575, 06432841, 07321983, 10356092, 10533039, 10932779, 11145411, 11898317, 12426715, 12475122, 13235503, 14244409, 15584662, 16792948, 17542343, 17542366
EE	Ravimiamet	1221039, 1454813, 1562969, 1715071
ES	Centro de información online de medicamentos de la AEMPS	05318001, 05318002, 05318003
FI	Lääkealan turvallisuus- ja kehittämiskeskus	023968, 098121, 504169
FR	Base de données publique des médicaments	61718111, 68155950
GB	Medicines & Healthcare Products Regulatory Agency	101546, 187597, 217003
HK	Department of Health Drug Office	54170
IE	Health Products Regulatory Authority	88233, 88239
IL	מִשְׂרַד הַבְּרִיאוּת	4988
IT	Agenzia del Farmaco	036982015
JP	医薬品医療機器総合機構	2190028F1021, 2190028F2028, 2190028R1028
LT	Valstybinė vaistų kontrolės tarnyba	1030689, 1053217, 1065921, 1078897, 1084547
NL	Z-Index G-Standaard, PRK	102296, 80365, 93351
PL	Rejestru Produktów Leczniczych	100116194, 100129357, 100277595
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W66755001
SG	Health Sciences Authority	13244P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699532097095
US	FDA, National Drug Code	0069-0336, 0069-0338, 0069-4190
ZA	Health Products Regulatory Authority	A40/7.1.5/0131