REVATIO

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

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 about Sildenafil

Medication package inserts

Below package inserts are available for further reading:

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