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Revatio (sildenafil) – Conditions or restrictions regarding supply and use - G04BE03

Updated on site: 09-Oct-2017

Medication nameRevatio
ATC CodeG04BE03
Substancesildenafil
ManufacturerPfizer Limited

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer(s) responsible for batch release

Fareva Amboise

Zone Industrielle

29 route des Industries

37530 Pocé-sur-Cisse France

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

At the request of the European Medicine Agency;

Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

Additional risk minimisation measures

The Marketing Authorisation Holder (MAH) shall agree the details of a controlled distribution system for the 20 ml vial of Revatio 0.8 mg/ml solution for injection with the National Competent Authorities and must implement such programme nationally to ensure that prior to prescribing all healthcare professionals who intend to prescribe and/or dispense Revatio 0.8 mg/ml solution for injection are provided with the following:

-Information for healthcare professionals

-Copy of the Summary of Product Characteristics (SPC)

-Data Capture Form (DCF) designed to facilitate reporting of events of hypotension and associated problems

The Information for healthcare professionals should contain the following key elements:

-Information about the Pharmacovigilance Monitoring Programme regarding the potential risk of clinically relevant hypotension and related problems to be put into place with the use of the DCF.

The Marketing Authorisation Holder shall agree the Information for healthcare professionals, and the healthcare professionals to be targeted, with the national competent authority of each Member State prior to the launch of the 20 ml vial of Revatio 0.8 mg/ml solution for injection in that country.

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