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Quinsair (levofloxacin) – Conditions or restrictions regarding supply and use - J01MA12

Updated on site: 09-Oct-2017

Medication nameQuinsair
ATC CodeJ01MA12
Substancelevofloxacin
ManufacturerHorizon Pharma Europe BV

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Adare Pharmaceuticals S.r.l. Via Martin Luther King, 13

20060 Pessano con Bornago (MI) Italy

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic safety update reports

The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation. Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of

Directive 2001/83/EC and 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.

Obligation to conduct post-authorisation measures

The MAH shall complete, within the stated timeframe, the below measures:

Description

Due date

To conduct a non-interventional post-authorisation safety study in a

Cumulative intermediate

registry of patients with cystic fibrosis to investigate the long term

analyses – annually.

safety profile of Quinsair in normal clinical practice in the European

Final study report – by

Union.

Q2 2022.

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