Pharmacovigilance contact form

You are notifying an adverse event/situation involving a medical drug. A person in charge of pharmacovigilance at Pierre Fabre will handle your notification and she/he may contact you.

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Any information provided will be confidential, respecting the privacy of personal data and medical and professional secrecy.

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HealthCare Professionals

This is an international website for BRAFTOVI® + MEKTOVI® dedicated to Healthcare professionals

IMPORTANT: the information on this website is based on the European Summary of Product Characteristics. Prescribing Information and indication may vary per country. You must refer to your country prescribing information. Please be aware we do not take responsibility for accessing such information which may not comply with the regulation or usage in your country.

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I am Healthcare Professional outside the US and I have read the information above.

Patients

This is an international website for BRAFTOVI^® + MEKTOVI^® dedicated to Healthcare Professionals.

I am a patient outside the US.

https://www.pierre-fabre.com/en

REFERENCES

1. BRAFTOVI^® Summary of Product Characteristics. Pierre Fabre Médicament.
2. MEKTOVI^® Summary of Product Characteristics. Pierre Fabre Médicament.
3. Dummer R, et Al. COLUMBUS 5-Year Update: A randomized, open-label, phase III trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAFV600–mutant melanoma. J. Clin. Oncol. (2022). DOI: 10.1200/JCO.21.026595-year publication.
4. Dummer R, Ascierto PA, Gogas HJ et al. Overall survival in patients with BRAF-mutant melanoma receiving encorafenib plus binimetinib versus vemurafenib or encorafenib (COLUMBUS): a multicentre, open-label, randomised, Phase 3 trial. Lancet Oncol 2018;19(10):1315–1327.
5. Ascierto PA, Dummer R, Gogas HJ et al. Update on tolerability and overall survival in COLUMBUS: landmark analysis of a randomised Phase 3 trial of encorafenib plus binimetinib vs vemurafenib or encorafenib in patients with BRAF^V600-mutant melanoma. Eur J Cancer 2020;126:33–44.
6. Gogas HJ, Flaherty KT, Dummer R et al. Adverse events associated with encorafenib plus binimetinib in the COLUMBUS study: incidence, course and management. Eur J Cancer 2019;119:97–106.
7. Gogas HJ, Dummer R, Ascierto PA et al. Quality of life in patients with BRAF-mutant melanoma receiving the combination encorafenib plus binimetinib: results from a multicentre, open-label, randomised, Phase III study (COLUMBUS). Eur J Cancer 2021;152:116–128.
8. Musoro JZ, Bottomley A, Coens C et al. Interpreting European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 scores as minimally importantly different for patients with malignant melanoma. Eur J Cancer 2021;104:169–181.
9. Trojaniello C, Festino L, Vanella V et al. Encorafenib in combination with binimetinib for unresectable metastatic melanoma with BRAF mutation. Expert Rev Clin Pharmacol 2019;12(3):259–266.
10. Heinzerling L, Elgentler TK, Fluck M et al. Tolerability of BRAF/MEK inhibitor combinations: adverse event evaluation and management. ESMO Open 2019;4(3):e000491.
11. Dummer R, Ascierto PA, Gogas HJ et al. Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised Phase 3 trial. Lancet Oncol 2018;19(5):603–615.
12. Lebbe C, Lorigan P, Ascierto PA et al. Treatment patterns and outcomes among patients diagnosed with unresectable stage III or IV melanoma in Europe: a retrospective, longitudinal survey (MELODY study). Eur J Cancer 2012;48(17):3205–3214.
13. Gogas HJ, et al. Updated Quality of Life (QoL) of encorafenib + binimetinib (COMBO450) versus (vs) vemurafenib (VEM) from COLUMBUS Part 1 Phase III study in BRAF-mutant melanoma. Presented at the 16th International Congress of the Society for Melanoma Research (SMR). November 20–23, 2019, Salt Lake City, Utah. USA.

This is an international website for BRAFTOVI^®+MEKTOVI^®. IMPORTANT: the information on this website is based on the European Summaries of Product Characteristics . Prescribing Information and indication may vary per country. You must refer to your country prescribing information. Please be aware we do not take responsibility for accessing such information which may not comply with the regulation or usage in your country.

HQ-MEK-09-23-2300001 Last update: September 2023

BRAFTOVI® is a trademark of Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc. MEKTOVI® is a trademark of Array BioPharma Inc. a wholly owned subsidiary of Pfizer Inc. © 2023, Pierre Fabre all rights reserved

Pharmacovigilance contact form

HealthCare Professionals​

Patients

HealthCare Professionals