- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).
Sildenafil Actavis is a medicine that contains the active substance sildenafil. It is available as tablets (25, 50 and 100 mg).
Sildenafil Actavis is a ‘generic medicine’. This means that Sildenafil Actavis is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Viagra.
Sildenafil Actavis is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity. For Sildenafil Actavis to be effective, sexual stimulation is required.
The medicine can only be obtained with a prescription.
The recommended dose of Sildenafil Actavis is 50 mg taken as needed about one hour before sexual activity. If Sildenafil Actavis is taken with food, the onset of activity may be delayed compared with taking Sildenafil Actavis without food. The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects. Patients with liver problems or severe kidney problems should start treatment with the 25-mg dose. The maximum recommended dosing frequency is one tablet per day.
The active ingredient in Sildenafil Actavis, sildenafil, belongs to a group of medicines called phosphodiesterase-type-5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax. This allows blood to flow into the corpora, producing the erection. By blocking the breakdown of cGMP, Sildenafil Actavis restores erectile function. Sexual stimulation is still needed to produce an erection.
Because Sildenafil Actavis is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Because Sildenafil Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
The CHMP concluded that, in accordance with EU requirements, Sildenafil Actavis has been shown to have comparable quality and to be bioequivalent to Viagra. Therefore, the CHMP’s view was that, as for Viagra, the benefit outweighs the identified risk. The Committee recommended that Sildenafil Actavis be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the European Union for Sildenafil Actavis on 10 December 2009.
For more information about treatment with Sildenafil Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Sildenafil Actavis : EPAR - Summary for the public
English (EN) (90.26 KB - PDF)
First published: Last updated:
български (BG) (142.22 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
español (ES) (92.49 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
čeština (CS) (116.17 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
dansk (DA) (90.06 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
Deutsch (DE) (91.47 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
eesti keel (ET) (89.49 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
ελληνικά (EL) (124.5 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
français (FR) (91.88 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
hrvatski (HR) (101.74 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
italiano (IT) (89.98 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
latviešu valoda (LV) (112.57 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
lietuvių kalba (LT) (113.39 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
magyar (HU) (112.57 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
Malti (MT) (116.86 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
Nederlands (NL) (90.72 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
polski (PL) (116.35 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
português (PT) (90.71 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
română (RO) (111.68 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
slovenčina (SK) (114.97 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
slovenščina (SL) (105.97 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
Suomi (FI) (111.94 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
svenska (SV) (91.1 KB - PDF)
First published: 21/12/2009Last updated: 11/05/2015
Product information
Sildenafil Actavis : EPAR - Product Information
English (EN) (221.67 KB - PDF)
First published: Last updated:
български (BG) (380.28 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
español (ES) (258.93 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
čeština (CS) (331.29 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
dansk (DA) (230.95 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
Deutsch (DE) (246.88 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
eesti keel (ET) (250.54 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
ελληνικά (EL) (394.58 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
français (FR) (244.33 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
hrvatski (HR) (317.43 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
íslenska (IS) (248.44 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
italiano (IT) (239.51 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
latviešu valoda (LV) (416.7 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
lietuvių kalba (LT) (333.9 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
magyar (HU) (360.87 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
Malti (MT) (355.69 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
Nederlands (NL) (234.89 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
norsk (NO) (226.03 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
polski (PL) (388.72 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
português (PT) (239.35 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
română (RO) (344.57 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
slovenčina (SK) (336.95 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
slovenščina (SL) (312.56 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
Suomi (FI) (325.14 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
svenska (SV) (233.18 KB - PDF)
First published: 07/05/2018Last updated: 13/11/2023
Latest procedure affecting product information: N/0026
10/11/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics(annex I);
- manufacturing authorisationholder responsible for batch release (annex IIA);
- conditions of themarketing authorisation(annex IIB);
- labelling(annex IIIA);
- package leaflet(annex IIIB).
Sildenafil Actavis : EPAR - All Authorised presentations
English (EN) (8.74 KB - PDF)
First published: Last updated:
български (BG) (32.14 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
español (ES) (11.63 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
čeština (CS) (14.47 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
dansk (DA) (8.55 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
Deutsch (DE) (8.53 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
eesti keel (ET) (11.28 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
ελληνικά (EL) (30.42 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
français (FR) (12.14 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
hrvatski (HR) (14.61 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
íslenska (IS) (11.61 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
italiano (IT) (10.8 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
latviešu valoda (LV) (23.19 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
lietuvių kalba (LT) (24.08 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
magyar (HU) (22.46 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
Malti (MT) (22.46 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
Nederlands (NL) (8.31 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
norsk (NO) (9.12 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
polski (PL) (14.21 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
português (PT) (11.27 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
română (RO) (22.21 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
slovenčina (SK) (14.84 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
slovenščina (SL) (11.44 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
Suomi (FI) (12.11 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
svenska (SV) (8.77 KB - PDF)
First published: 21/12/2009Last updated: 08/07/2016
Product details
- Name of medicine
Sildenafil Actavis
- Active substance
sildenafil
- International non-proprietary name (INN) or common name
sildenafil
- Therapeutic area (MeSH)
Erectile Dysfunction
- Anatomical therapeutic chemical (ATC) code
G04BE03
Pharmacotherapeutic group
Urologicals
Therapeutic indication
Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
In order for Sildenafil Actavis to be effective, sexual stimulation is required.
Authorisation details
- EMA product number
EMEA/H/C/001090
Generic
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
- Marketing authorisation holder
Actavis Group PTC ehf
Dalshraun1
220 Hafnarfjörður
Iceland- Opinion adopted
24/09/2009
- Marketing authorisation issued
10/12/2009
- Revision
17
Assessment history
Sildenafil Actavis : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (132.64 KB - PDF)
First published: Last updated:
Sildenafil Actavis : EPAR - Public assessment report
English (EN) (160.21 KB - PDF)
First published: Last updated:
Committee for medicinal products for human use, summary of positive opinion for Sildenafil Actavis
AdoptedReference Number: EMEA/CHMP/440521/2009
English (EN) (32.53 KB - PDF)
First published: Last updated:
More information on Sildenafil Actavis
Questions and answers on generic medicines
Reference Number: EMA/393905/2006 Rev. 2
English (EN) (66.45 KB - PDF)
First published: Last updated:
български (BG) (93.16 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
español (ES) (68.3 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
čeština (CS) (87.71 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
dansk (DA) (66.79 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
Deutsch (DE) (67.55 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
eesti keel (ET) (65.21 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
ελληνικά (EL) (91.29 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
français (FR) (68.35 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
hrvatski (HR) (87.8 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
italiano (IT) (67.62 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
latviešu valoda (LV) (111.81 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
lietuvių kalba (LT) (86.76 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
magyar (HU) (85.76 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
Malti (MT) (89.35 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
Nederlands (NL) (66.81 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
polski (PL) (88.51 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
português (PT) (68.32 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
română (RO) (86.9 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
slovenčina (SK) (87.73 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
slovenščina (SL) (84.8 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
Suomi (FI) (66.21 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
svenska (SV) (67.11 KB - PDF)
First published: 09/07/2007Last updated: 07/12/2012
Topics
Generic and hybrid medicines
Medicines
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