Sildenafil ratiopharm

Authorised

This medicine is authorised for use in the European Union

sildenafil

Overview

This is a summary of the European public assessment report (EPAR) for sildenafil. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for sildenafil.

What is Sildenafil ratiopharm?

Sildenafil ratiopharm is a medicine that contains the active substance sildenafil. It is available as tablets (25, 50 and 100 mg).

Sildenafil ratiopharm is a ‘generic medicine’. This means that Sildenafil ratiopharm is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Viagra.

What is Sildenafil ratiopharm used for?

Sildenafil ratiopharm is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a sufficiently hard penis (erection) for satisfactory sexual activity. For Sildenafil ratiopharm to be effective, sexual stimulation is required.

The medicine can only be obtained with a prescription.

How is Sildenafil ratiopharm used?

The recommended dose of Sildenafil ratiopharm is 50 mg taken as needed about one hour before sexual activity. If Sildenafil ratiopharm is taken with food, the onset of activity may be delayed compared with taking Sildenafil ratiopharm 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 reduced liver function or severely reduced kidney function should start treatment with the 25-mg dose. The maximum recommended dosing frequency is one tablet per day.

How does Sildenafil ratiopharm work?

The active ingredient in Sildenafil ratiopharm, 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 ratiopharm restores erectile function. Sexual stimulation is still needed to produce an erection.

How has Sildenafil ratiopharm been studied?

Because Sildenafil ratiopharm is a generic medicine, studies in patients 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.

What are the benefit and risk of Sildenafil ratiopharm?

Because Sildenafil ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has Sildenafil ratiopharm been approved?

The CHMP concluded that, in accordance with EU requirements, Sildenafil ratiopharm 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 ratiopharm be given marketing authorisation.

Other information about Sildenafil ratiopharm

The European Commission granted a marketing authorisation valid throughout the European Union for Sildenafil ratiopharm on 23 December 2009.

For more information about treatment with sildenafil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Sildenafil ratiopharm : EPAR - Summary for the public

Product information

Sildenafil ratiopharm : EPAR - Product Information

Latest procedure affecting product information: IB/0052

21/06/2022

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 authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Sildenafil ratiopharm : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Sildenafil ratiopharm
• 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 to be effective, sexual stimulation is required.

Authorisation details

• EMA product number:
  EMEA/H/C/001080
• 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:
  Ratiopharm GmbH

  Graf-Arco-Str. 3; D-89079 Ulm; Germany

• Marketing authorisation issued:
  23/12/2009
• Revision:
  19

Assessment history

Changes since initial authorisation of medicine

Sildenafil ratiopharm : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Sildenafil ratiopharm : EPAR - Public assessment report