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Fablyn (lasofoxifene tartrate) – Conditions or restrictions regarding supply and use - G03

Updated on site: 06-Oct-2017

Medication nameFablyn
ATC CodeG03
Substancelasofoxifene tartrate
ManufacturerDr. Friedrich Eberth Arzneimittel GmbH

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

 

Not applicable

 

Name and address of the manufacturer responsible for batch release

 

Pfizer Manufacturing Deutschland GmbH

authorised

Heinrich Mack Strasse 35

 

D-89257 Illertissen

 

Germany

 

B. CONDITIONS OF THE MARKETING AUTHORISATION

 

longer

CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE

MARKETING AUTHORISATION HOLDER

Medicinal product subject to medical prescription.

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

 

no

The Marketing Authorisation Holder (MAH) shall e sure that, prior to launch, all healthcare

product

 

professionals who are expected to pres ribe FABLYN or order gynaecological ultrasound of patients treated with FABLYN, are provided with a ess to risk minimisation educational programme.

The programme shall have both electronic and printed form, which are identical in terms of content. The programme materials shall be provided via the following means:

Medicinal

 

Web-based

 

On CD

 

Printed on paper

The programme shall convey the following key messages:

FABLYN increases risk of venous thromboembolism (VTE).

The approaches recommended for mitigation of risk of venous thromboembolism based on the SmPC, including contraindication of FABLYN in patients with active or past history of VTE.

FABLYN causes morphologic changes, particularly the cystic atrophy of endometrium. It results in increased mean endometrial thickness.

Based on the clinical trials, the morphologic changes caused by FABLYN are benign and do not require further investigation unless vaginal bleeding occurs.

References to authoritative international guidelines relevant for uterine surveillance.

The need to stop treatment with FABLYN and investigate when unexplained uterine bleeding occurs.

The programme shall include the full text of the SmPC.

In addition, an updated RMP should be submitted
Risk Management Plan

The MAH shall also provide access to educational programme for pathologists. This programme should focus on interpretation of endometrial biopsy of women treated with FABLYN. It must be in line with authoritative international guidelines and supported by evidence published in peer reviewed medical journals.

OTHER CONDITIONS

Pharmacovigilance system

The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst theauthorisedproduct is on the market. The MAH commits to performing the studies and additional pharmacovigilance activities detailed in

the Pharmacovigilance Plan, as agreed in version 1.4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.

As per the CHMP Guideline on Risk Management Systems for medicin l products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).

 

When new information is received that may impact n the current Safety Specification,

 

 

 

no

 

Pharmacovigilance Plan or risk minimisati n activitieslonger

Within 60 days of an important (pharmac vigilance or risk minimisation) milestone being

 

reached

product

 

At the request of the EMEA

 

Medicinal

 

 

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