Products Catalog

Products Catalog

Product Portfolio

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ABOUT US… At Provepharm, we reinvent the model of pharmaceutical innovation by vitalizing molecules and contribute to improve, day after day, hospital practices and speciality care offered to patients. We are an independent French Pharmaceutical Company and our products are distributed in more than 30 countries worldwide. We vitalize molecules in redefining quality standards, maximizing therapeutic potential and uncovering new therapeutic properties. Molecule Vitalization can turn existing molecules into new treatments with new promise and shorten the development of new drugs. Our products, which meet the highest pharmaceutical quality standards, are available in hospitals in many countries worldwide. CERTIFICATIONS

OUR PRODUCTS ARE MANUFACTURED IN FRANCE

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Provepharm commitment

Health:

Environment:

›  Provepharm supports the HOPE Project Association which collects funds to renovate the Pediatric care unit of the Timone Hospital in Marseille. The aim of this project is to improve children & families’ journey at the hospital. ›  Provepharmwas awarded the Galien Medstartup prize in 2018 for its commitment to fight against malaria. Proveharm decided to join forces with theWalter Red Army Institute of Research (WRAIR) to fund a dedicated international consortium and develop an ambitious clinical program aiming to evaluate the use of methylene blue in the treatment of malaria in a « no gain, no loss » economic model for the company.

Provepharm Life Solutions has decided to control and reduce its environmental footprint since 2015. Today, › We develop patented &innovative synthesis pathways without metallic catalysers to produce the active ingredients of our antidotes and surgical dyes. › We favour the manufacturing of our products in ISO 14001 certified production plants. › We favour recyclable packaging for our products by using sustainable materials such as glass and cardboard (90%). › We commit to minimize the use of non-recyclable materials when developing new packaging for our products by 2025. › We commit to group wholesalers and distributors supplies together in order to limit carbon dioxide emissions. › We raise our employees’ awareness of the environmental protection by reducing wastes and by encouraging the use of sustainable/recyclable materials.

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Antidote Portfolio

METHYLTHIONINIUM CHLORIDE PROVEBLUE 2ML

INN Methylthioninium chloride Dosage 5 mg/ml (0.5%) Presentation

Box of 5 ampoules of 10 ml Box of 5 ampoules of 2 ml Administration Solution for injection. Slow IV injection only Dilution in 50 ml glucose 50 mg/ml (5%) solution for injection Must be used immediately after opening or dilution. For single use only Indication Acute symptomatic treatment of medicinal and chemical products-induced methaemoglobinaemia. Methylthioninium chloride Proveblue is indicated in adults, children and adolescents (aged 0 to 17 years old). Shelf life and Storage 3 years. Do not refrigerate or freeze. Marketing Autorisation Holder Provepharm SAS Marketing Autorisation granted in European Countries: Methylthioninium Chloride Proveblue 5 mg/ml, solution for injection USA: ProvayBlue® Australia: Proveblue® Methylene blue 50 mg/10 mL solution for injection New Zealand: Proveblue® Methylene blue 50 mg/10 mL solution for injection South Korea: Proveblue injection 0.5% Methylene Blue

METHYLTHIONINIUM CHLORIDE PROVEBLUE 10ML

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Surgical colouring agents

PROVEDYE® 2ML

Composition Methylene Blue (Proveblue ® ) diluted in water solution for injection Dosage 5 mg/ml (0.5%) Presentation

Dispositif médical – 2 ml GTIN 3760237160188

Box of 5 ampoules of 2 ml Box of 5 ampoules of 10 ml Administration

0,5% Bleu de méthylène Ne pas injecter en IV

Solution for local or oral administration. PROVEDYE ® may be diluted in water (for oral use only) or in normal saline solution. PROVEDYE ® must be used immediately after opening or dilution Indications Marker for surgical visualization such as intra operative seal tests, leakages visualization and delineation of the fistula tract Shelf life and Storage 3 years. Do not refrigerate PROVEDYE ® under 8°C. Do not freeze. For single use only Status Medical device CE-Marked - class IIa. 2797 Manufacturer Provepharm SAS

PROVEDYE® 10ML

INK U.V.

Packaging line : BAUSCH Format : 19 x 36 mm Version 1 : 10.01.2019 CREATION

Label 2ml U Format : 19 x 36 Version C

INK U.V.

LINEWORK

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LINEWORK

Arial - Regular - mini. 5 pt Arial - Bold - mini. 7 pt Provepharm Regular - mini. 7 pt

Nutrition Disorders Portfolio Injectable Mono-Vitamins Arial - mini. 7 pt (Cenexi code 5 pt)

VITAMIN A PROVEPHARM 100 000 U.I. /2 ML SOLUTION FOR INJECTION (I.M.)

VITAMIN E PROVEPHARM 100 MG /2 ML SOLUTION FOR INJECTION INN Alpha tocopherol acetate (Vitamin E) Dosage 100 mg/2 ml Presentation Box of 6 or 12 ampoules of 2 ml Administration Deep intramuscular injection Pediatric population only: intravenous injection with lipid emulsion by infusion Indications Vitamin E deficiency, when oral route is not possible; Digestive malabsorption of vitamin E. Vitamin E intake by intramuscular injection during elemental enteral feeding. Shelf life&Storage 3 years. Store at a temperature not exceeding 25°C. After opening: the product must be used immediately Marketing Autorisation Holder Provepharm SAS

INN Retinol palminate (vitamin A) Dosage 100 000 U.I./2 ml Presentation Box of 6 ampoules of 2 ml Administration Solution for injection Deep intramuscular injection

PRIMARY PACKAGING

PRIMARY PACKAGING

Vitamine A PROVEPHARM EXP Lot 100 000 U.I. /2 ml Voie I.M. palmitate de rétinol

EXP Lot 100 mg/2 ml Voie IM ou IV Acétate d’alpha-tocophérol V ITAMINE E PROVEPHARM

Indications Vitamin A deficiency, when oral route is not possible; Digestive malabsorption of vitamin A. Vitamin A intake during elemental enteral feeding. Shelf life&Storage 18months. Store at a temperature not exceeding 25°C

SECONDARY PACKAGING

SECONDARY PACKAGING

MarketingAutorisationHolder ProvepharmSAS

Marketing Autorisation granted in France

Marketing Autorisation granted in France

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Metabolism Portfolio

Neuroscience Portfolio

FEGENOR ® CAPSULE

QUITAXON ® TABLET

INN Fenofibrate Dosage 140mg or 200mg Présentation FEGENOR ® 140mg: Box of 30 or 90 capsules FEGENOR ® 200mg: Box of 30 capsules Indications Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol level. Mixed hyperlipidaemia when a statin is contraindicated or not tolerated. Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol levels are not adequately controlled. Shelf life &Storage 3 years. Store at a temperature not exceeding 25°C Marketing Autorisation Holder Provepharm SAS

INN Doxepine Dosage 10mg or 50mg Presentation

FEGENOR ® 140 MG

QUITAXON ® 10 MG

Quitaxon ® 10mg: box of 40 tablets Quitaxon ® 50mg: box of 20 tablets Indication Major depressive episodes (ie characterized)

Shelf life 3 years

Marketing Autorisation Holder Provepharm SAS

Marketing Autorisation granted in France

QUITAXON ® 50 MG

FEGENOR ® 200 MG

Marketing Autorisation granted in France

> Contact Details

Provepharm SAS: 22 rue Marc Donadille 13013 Marseille France +33 4 91 08 69 30 www.provepharm.com

Medical Information &

Pharmacovigilance: +33 4 91 08 69 30 [email protected]

> Notes

Provepharm Life Solutions, the molecule vitalisation company since 1998, making old molecules new again and providing premium healthcare solutions.

This brochure is eco-designed and printed with a biodegradable ink. The printing company is certified Imprim’vert and follows the FSC standards Photo credit: Istock.fr, Yoan Blanc NP/ 20 / 09 -01 4