Welcome to the website of the Federal Agency for Medicines and Health Products
Role of the FAMHP
We ensure the quality, safety and efficacy of medicines and health products in clinical development and on the market.
Breast implants from Poly Implant Prothèse (PIP)
FAQ - Contact CenterClick here to find answers to frequently asked questionsabout it (in French).For more information, please call the Contact Center on 0032 2 524 97 97, from 8 am to 17 pm. Communiqué 02/02/2012 |
NEWS
-
Breast implants - POLY IMPLANT PROTHESE (PIP)
Following the consultation meeting on Tuesday, January 10, 2012, the previous recommendations were reiterated. The mutual insurance system pays, in line with the normal rules of application in the field of health insurance. The Contact Center of the Federal Public Health is available to the public.
read more -
Mixtard 30 (human insulin): marketing stopped after December 31st 2011
After December 31st 2011 Novo Nordisk stopped marketing the human insulin Mixtard 30 for commercial reasons. Mixtard 30 may be delivered in pharmacies while stocks last. Transition for a patient to another treatment should be under strict medical supervision.
read more -
Information for the attention of marketing authorization (MA) holders of medicinal products for human use
A document setting out the requirements for Type II variations of the marketing authorisation file, involving a revision of sections 4.6 (fertility, pregnancy and lactation), 5.3 (preclinical safety data) and 6.6 (special precautions for disposal of a used medicinal product or waste materials derived from such a medicinal product and other handling of the product) of the summary of product characteristics (SPC) is published on the page about variations in the column "Marketing authorization procedure" for medicines for human use.
read more -
Breast implants POLY IMPLANT PROTHESE (PIP)
The FAMHP became aware of the recent evaluations carried out by the French Agency for Sanitary Safety of Health Products (AFSSAPS) on implants manufactured by POLY IMPLANT PROTHESE (PIP). As a precaution the FAMHP recommends that the monitoring of patients be reinforced and that women who have doubts consult their doctor.
read more
