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EllaOne (ulipristal) – Conditions or restrictions regarding supply and use - G03AD02

Updated on site: 06-Oct-2017

Medication nameellaOne
ATC CodeG03AD02
Substanceulipristal
ManufacturerLaboratoire HRA Pharma

A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Cenexi

17 Rue de Pontoise

95520 Osny France

or

Laboratorios León Farma S.A.

C/ La Vallina, s/n Pol. Ind. Navatejera 24008 Navatejera, León

Spain

or

Delpharm Lille S.A.S.

Parc d’activités Roubaix-Est 22, rue de Toufflers

CS 50070

59452 Lys-Lez-Lannoy France

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product not subject to medical prescription.

Official batch release

In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.

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 Medicines 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.

If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.

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