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These materials have been approved and / or notified to regulatory authorities. Please use the material for your respective country.

These materials are not intended to condition the prescription, use, promotion, sale, recommendation, indication or approval of any Roche product or any concession of benefits to Roche.

Pharmacovigilance

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Sections
Risk Minimization

Version: RMP 8.0 / ARMM 2.0.1

This activity to minimize risks to public health consists in a Pregnancy Prevention Program designed to minimize the risk of teratogenicity and provide education on the risk of teratogenicity and the recommended contraceptive measures to prevent fetal exposure. The objectives are to prevent exposure to vismodegib in pregnant women and inform patients of the teratogenic risks to the fetus that are associated with vismodegib use.

Version: RMP 9.0 / ARMM 2.0

Objective: This material aims to remind healthcare professionals about the correct technique for administering the MabThera SC, its storage; as well as emphasizing the differences in packaging between the intravenous and subcutaneous formulation, in order to minimize the possibility of medication errors. Finally, we wish to highlight that the subcutaneous formulation is approved only for the use of Non-Hodgkin's Lymphoma. All the information contained in the material is indicated in the label and approved by the Health Authority.

Version: RMP 5.0 / ARMM 3.0

This activity to minimize risks to public health aims to remind patients that Roaccutane® is totally contraindicated in women with the potential to have children unless the patient with the condition of the Pregnancy Prevention Program (PPP) as detailed in the product information. To avoid fetal exposure to Roaccutane®, providing educational materials to patients prescribed Roaccutane® to reinforce patient’s understanding of the risk of birth defects and key elements of the PPP such as the critical importance of effective contraception methods while taking Roaccutane®.

Version: RMP 3.0 / ARMM 2.0

Objetive: This material aims to inform patient/carers adequately on the risks, the key signs and symptoms of those risks, and when to seek urgent attention from their physician with the objective to minimize the important identified risks of infectious endophthalmitis and intraocular inflammation; and to promote communication between the patient and their physician.

(exclusive for Aruba, Guyana, Curacao, Jamaica, and Trinidad & Tobago)
M-AI-00000678

(Antigua and Barbuda, Bahamas, Barbados, Bermuda, Cayman Islands, Grenada, Saint Lucia, Turks and Caicos Islands)
M-AI-00000678 v3.0

Safety Communication Letters
Here you will find Security Letters issued from January 2014 to date:

Material created by Roche. | All rights reserved - reproduction in whole or in part is prohibited without the prior written authorization of Roche Servicios S.A.
This material may contain information regarding investigational medicinal products or active substances, or indications not yet approved in your country, with the aim of providing medical and/or scientific information of interest to healthcare professionals. Roche does not recommend the use of any product in any indication, dosage, or route of administration that is not clearly listed in the product insert or marketing authorization approved by the local regulatory authority.
For healthcare professionals only.

This product is approved in all countries in the Caribbean, Central America and Venezuela region.

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