74th Edition
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`The Dictionary
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`All rights to reproduction, addition and supplement are reserved for the Editor
`© Copyright by OVP 1998
`(This work is governed by the provisions of Articles 9 and 13 of the Law of 11 March 1957)
`
`Lilly Ex. 2032 pg. 1
`Sandoz v. Lilly IPR2016-00318
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`
`CONTENTS
`
`
`
`GENERAL INFORMATION
`
`
` Text of Therapeutic Indications.....................................................2
`Immunization Schedule.................................................................2
`
` Preface..........................................................................................3
` Patients’ Associations...................................................................4
` French Poison Control Centers......................................................4
` Pharmacovigilance and Pharmacodependence Centers..............5
` Doping Substances and the Use of Banned Doping Agents..........6
`
`
`
`MEDICATIONS
`
` 
`
` Classification by common name.......................................BLUE Section
` Classification by pharmacotherapeutic family..............YELLOW Section
` Classification in alphabetical order.................................WHITE Section
` Medications
` Contrast Agents
` BLOOD and its labile components..................end of WHITE Section
`
`
`
`CARE, HYGIENE AND HEALTH PRODUCTS...........................PINK Section
`
`Index of Products
`
` 
`
` Accessories, medical, surgical and orthopedic equipment, dressings and
`preservatives
` Disinfection, hospital and domestic sterilization
` Dietetics, Diet and Nutrition
` Hygiene, Cosmetology
` Reagents and Tests
` Balneology, health facilities, thalassotherapy and hydrotherapy
`(in each chapter, the monographs are preceded by a classification according to
`category)
`
`DIRECTORY OF MEDICATIONS AND PRODUCTS
`ACCORDING TO ESTABLISHMENT......................................GREEN Section
`
`
`
`ANNEXED FASCICLES:
`
`Supplementary Specifications (1st Update)
`Drug Interactions
`
`
`
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`Lilly Ex. 2032 pg. 2
`Sandoz v. Lilly IPR2016-00318
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`
` ©
`
` Copyright by OVP 1998
`The Intellectual Property Code, under the terms of Article L.122-5, authorizes on the one hand
`no “copies or reproductions apart from those strictly reserved for private use by the copyist and
`not intended for collective use” and, on the other hand, “provided that the name of the author
`and the source, the analyses and short citations supported by the critical, polemic, pedagogic,
`scientific or informative nature of the work in which they are incorporated are clearly indicated,”
`full or partial reproduction made without the consent of the author or his/her successors in title
`or assignees is illegal, as well as any translation, adaptation or transformation, arrangement or
`reproduction by any method whatsoever (Article L.122-4). Such unauthorized reproduction
`shall constitute an infringement sanctioned by Articles L.335 et seq. of the Intellectual Property
`Code.
`This prohibition covers in particular the use and exploitation of the work or texts of which it is
`comprises by any method such as entry, manipulation and storage in a data bank, reproduction
`or transmission by any means or forms whatsoever, such as electronic, mechanical,
`photographic, photocomposition, cinematographic, magnetic, computerized, telematic, via
`satellite, as well as by any other means existing or to be created.
`The insertion of extracts in a work or in a training document is forbidden.
`The use of the mark VIDAL® is forbidden except when it is associated with a quote from the
`work, all rights being reserved for all countries.
`
`
`Lilly Ex. 2032 pg. 3
`Sandoz v. Lilly IPR2016-00318
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`
`MAGNESIUM
`Chloro-magnesium oral solution
`Delbiase tablet
`Efimag powder for oral solution
`Ionimag effervescent table
`Mag 2 powder for oral solution, oral solution
`Magné B6 coated tablet, oral solution
`Magnesium Glycocolle Lafarge coated tablet
`Magnespasmyl coated tablet, granulate
`Magnogene gel capsule, oral solution
`Magnosol effervescent granulate (CC)
`Megamag gel capsule
`Oromag tablet to suck
`Pidolate of magnesium-ratiopharm powder for oral solution, oral solution
`Solumag oral solution
`Spasmag gel capsule, oral solution
`Top Mag powder for oral solution
`Uvimag B6 oral solution
`
`PHOSPHORUS
`Phosphoneuros oral solution
`Phosphore-Sandoz effervescent tablet
`
`POTASSIUM
`
`Liquid forms
`Potassium Gluconate H3 Santé syrup
`Potassium Richard syrup
`
`Intestinal sustained-release dry forms
`Diffu-K capsule
`Kaleorid Leo sustained-release, sustained-release coated tablet
`
`Intestinal fast-release dry form
`Nati-K coated tablet
`
`ZINC
`Zymizinc oral solution
`
`VITAMINS
`
`VITAMIN A
`A 313 capsules
`Arovit Roche coated tablet
`Avibon capsules
`
`GROUP B VITAMINS
`
`Vitamin B1 or thiamine
`Benerva coated tablet, solution for intramuscular injection
`
`Lilly Ex. 2032 pg. 4
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`Bevitine coated tablet, solution for intramuscular injection
`
`Vitamin B2 or riboflavin
`Beflavin coated tablet
`
`Vitamin B5 or dexpanthenol
`Bepanthene tablet, intramuscular & intravenous solution for injection
`
`Vitamin B6 or pyridoxine
`Becilan bisected tablet, intramuscular & intravenous solution for injection
`Pyridoxine Aguettant, intramuscular & intravenous solution for injection
`Vitamin B6 Richard scored tablet
`
`Vitamin B9 or folic acid
`Speciafoldine tablet
`
`Folinic acid
`Elvorine powder for solution for intramuscular & intravenous injection
`Aguettant calcium folinate powder for solution for injection, solution for
`intramuscular & intravenous injection
`Dakota Pharm calcium folinate powder for solution for injection, solution for
`intramuscular & intravenous injection
`Roger Bellon calcium folinate solution for intramuscular & intravenous injection
`Lederfoline powder and solvent for solution for intramuscular & intravenous
`injection, solution for intramuscular & intravenous injection
`Perfolate power for solution for intramuscular & intravenous injection
`
`Vitamin B12
`and Vitamin B12 derivatives
`- Hydroxocobalamin
`Dodecavit solution for intramuscular injection
`- Cyanocobalamin
`Delagrange Vitamin B12 (CC)
`Vitamin B12 Delagrange oral and intramuscular injection solution (CC)
`Vitamin B12 Gerda tablet
`- Hydroxocobalamin + cobamamide
`Vibalgan powder and solvent for solution for injection
`
`Vitamins related to B-Group Vitamins
`- Vitamin H or biotin
`Biotin Roche tablet, solution for subcutaneous, intramuscular & intravenous
`injection
`
` -
`
` Vitamin PP or nicotinamide
`Nicobion coated tablet
`
`intramuscular & intravenous
`
`injection, and for
`
` B
`
` vitamin complexes
`B Chabre coated tablet
`Becozyme solution for
`intravenous perfusion
`
`Lilly Ex. 2032 pg. 5
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`
`Terneurine coated tablet
`B1-B6 Roche Vitamins coated tablet
`
`VITAMIN C OR ASCORBIC ACID
`
`Richard calcium ascorbate granulate
`Laroscorbine chewable tablet, effervescent tablet, power for oral solution,
`intramuscular & intravenous solution for injection, solution for intravenous
`injection
`Laroscorbine sugar-free chewable tablet, effervescent tablet, powder for oral
`solution
`Midy vitamin C 1000 powder for oral solution
`Midy vitamin C 1000 effervescent sugar-free powder for oral solution
`Midy vitamin C 250 chewable tablet and tablet to suck
`Midy vitamin C 500 chewable tablet
`Tempodia sustained-release gel capsule
`Vitamin C 1000 Inava effervescent granulate
`Vitamin C Aguettant solution for injection for intravenous perfusion
`Vitamin C Arkovital gel capsule
`Vitamin C Oberlin chewable tablet, scored effervescent tablet, powder for oral
`solution
`Vitamin C Pierre Fabre power for oral solution
`Vitamin C Upsa chewable tablet
`Vitamin C Upsa effervescent, scored effervescent tablet
`Vitascorbol effervescent tablet
`Vitascorbol sugar-free chewable tablet
`
` D
`
` VITAMINS
`
`
`Natural D Vitamins
`- Vitamin D2 or ergocalciferol
`Sterogyl oral solution
`Sterogyl 15 A oral solution
`Sterogyl 15 H oral solution and for intramuscular injection
`Uvesterol D oral solution
`Zyma-D2 oral solution
`- Vitamin D3 or colecalciferol
`Adrigyl oral solution
`Uvedose oral solution
`Vitamin D3 Bon oral solution and for intramuscular injection
`
`Hydroxylated D3 Vitamins
`- Vitamin D3 hydroxylated on C25: 25 (OH) D3
`Dedrogyl oral solution
`- Vitamin D3 hydroxylated on C1: 1 α(OH) D3
`Un-Alfa capsules, oral solution, solution for intravenous injection
`- Dihydroxylated Vitamin D3: 1.25 (OH)2 D3
`Rocaltrol caps
`
`Group D vitamins
`
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`- D vitamins + calcium
`Cacit vitamin D3 effervescent granulate
`Calcidose Vitamin D powder for oral solution
`Calciprat D3 tablet to suck
`Calcium-Vitamin D3 GNR chewable and suckable tablet
`Calperos D3 tablet to suck
`Caltrate vitamin D3 scored coated tablet
`Densical Vitamin D3 granulate for oral solution
`Dossifil oral solution
`Frubiose Vitamin D oral solution
`Ideos tablet to suck
`Orocal D3 tablet to suck
`- D vitamins + other vitamins
`Auxergyl D3 oral solution
`Uvesterol Vitaminé A, D, E, C oral solution
`
`VITAMIN E
`Ephynal coated tablet
`Tocalfa capsules
`Tocomine coated tablet
`
`VITAMIN COMPLEXES
`
`Vitamin complexes: deficiency or lack
`Alvityl coated tablet, syrup
`Arkogélules, cod liver oil capsule
`BON Hydrosol multivitamin capsules, oral solution
`Roche Hydrosol multivitamin capsules, oral solution
`
`Vitamins and mineral elements: deficiency or lack
`Azedavit coated tablet
`Azinc Complex gel capsule
`Berocca effervescent tablet
`Elevit Vitamin B9 coated tablet
`Forvital coated tablet
`Plenyl chewable tablet, effervescent tablet
`Quotivit OE coated tablet
`Supradyne effervescent tablet
`Survitine capsules
`Synergyl chewable tablet
`Vivamyne coated tablet
`Zedene C coated tablet
`
`ANTIASTHENICS
`
`VITAMIN-BASED COMPLEXES
`Adena C coated tablet
`Arginotri-B coated tablet
`Arphos vitamin B12 oral solution
`Ascortonyl oral solution
`
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`Becozyme coated tablet
`Betaselen gel capsule
`Betriphos-C gel capsule
`Ca C 1000-Sandoz effervescent tablet
`Carencyl capsules
`Glutamag Vitaminé oral solution
`Guronsan effervescent tablet
`Inositol Lysivit B12 oral solution
`Myoviton coated tablet
`Osteogen tablet
`Pharmaton capsules
`Plurifactor dual-core coated tablet
`Polytonyl powder for oral solution
`Princi-B coated tablet
`Revitalose oral solution
`Rovigon coated chewable tablet
`Supradyne effervescent tablet
`Survitine capsules
`Tonicalcium oral solution
`Favored high-energy Trophysan oral solution
`Lemoine Vitamins C + B2 oral solution
`Vitascorbol soluble granulate for oral solution
`Vitascorbol buffered tablet
`Vitathion effervescent granulate
`
`AMINO ACIDS
`Actitonic oral solution
`Activarol oral solution
`Carnitine Arkopharma chewable tablet
`Dynamisan powder for oral solution, oral solution
`Energitum oral solution
`Hematon oral solution
`Sargenor oral solution
`Sugar-free Sargenor chewable tablet, effervescent tablet
`Stimol oral solution
`
`MINERAL ANTIASTHENICS
`Actiphos oral solution
`Ionyl oral solution
`Salibra oral solution
`Stimuplexe oral solution
`Triphosmag oral solution
`
`PHYTOTHERAPY
`Actisane Fatigue Passagere herbal tea
`Arkogélules Ginseng gel capsule
`Elusanes Ginseng gel capsule
`Elusanes Ginseng 200 gel capsule
`Elusanes Maté gel capsule
`Elusanes Green Tea gel capsule
`
`Lilly Ex. 2032 pg. 8
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`Ginsana capsules
`Ginseng Alpha gel capsule
`Ginseng Arik gel capsule
`Ginseng Boiron gel capsule
`Hippophan syrup
`Kolan Boiron gel capsule
`Natura Medica Ginseng oral solution
`Tonactil gel capsule
`Tonisan tablet to suck
`
`HORMONE REPLACEMENT THERAPY
`Surélen oral solution
`
`HOMEOPATHY
`Amphosca Orchitine chewable tablet
`Amphosca Ovarine chewable tablet
`Complexe Lehning No 5 oral solution
`Homéopathie Abbé Chaupitre No 48 oral solution
`Homéopathie Boripharm No 31 granules
`Osteocynesine tablet
`Rexorubia granulate
`Tonique Vegetal oral solution
`
`TRACE MINERAL ELEMENTS
`Oligocure oral solution
`Oligogranul Cuivre-Or-Argent [copper-gold-silver] tablet
`Oligogranul Manganese-Cuivre-Cobalt [manganese-copper-cobalt] tablet
`Oligosol Cuivre-Or-Argent sublingual solution
`Oligosol Manganese-Cuivre-Cobalt sublingual solution
`Oligostim Cuivre-Or-Argent sublingual tablet
`Oligostim Manganese-Cuivre-Cobalt sublingual tablet
`
`PROCAINE
`Procaine Lavoisier solution for injection
`
`MISCELLANEOUS
`Biotone oral solution
`Curasten oral solution
`Hemedonine oral solution, solution for intramuscular injection
`Kola Astier coated tablet
`Leuco-4 tablet
`Marinol syrup
`Megasthenyl oral solution
`Neurosthenol oral solution
`Nevrosthenine Glycocolle Freyssinge granulate for oral solution
`Phytemag gel capsule
`Plasmarine syrup
`Weleda nutritional calcareous salts oral powder
`Stivane gel capsule
`Surfotan oral solution
`
`Lilly Ex. 2032 pg. 9
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`
`CORRECTION OF METABOLIC ABNORMALITIES
`
`CARNITINE DEFICIENCIES
`Levocarnil oral solution, solution for intramuscular and intravenous injection
`
`PHENYLKETONURIA
`Lofenalac Mead Johnson powder for oral suspension
`
`ORAL AND ENTERAL NUTRITION
`Cetornan powder for oral and enteral solution
`Renutryl oral and enteral emulsion
`
`MISCELLANEOUS
`
`SWEETENERS
`Sucaryl capsule, granulate, oral solution
`
`ASEPTIZATION OF DRINKING WATER
`Hydroclonazone tablet
`
`NEUROLOGY
`
`ANTIEPILEPTICS
`
`BARBITURATE ANTIEPILEPTICS
`
`Uncombined phenobarbital
`Aparoxal scored tablet
`Gardenal tablet, powder and solvent for solution for intramuscular injection
`
`Primidone
`Mysoline scored table
`
`Combined Phenobarbital
`Alepsal tablet
`Kaneuron oral solution
`
`NON-BARBITURATE ANTIEPILEPTICS
`
`Benzodiazepines
`Rivotril quadrisected tablet, solution to be diluted and solvent for intramuscular
`and intravenous solution for injection, oral solution
`Urbanyl scored tablet
`Valim Roche solution for intramuscular and intravenous injection and [illegible]
`
`Carbamazepine
`Tegretol scored tablet, oral suspension
`Tegretol sustained-release scored coated tablet [illegible]
`Surmontil oral solution (Mesilate)
`
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`
`Surmontil solution for intramuscular injection (Mesilate)
`
`Trinitrine
`Cordipatch
`Corditrine
`Diafusor
`Discotrine
`Lenitral gel capsule (sustained-release microgranules)
`Percutaneous Lenitral
`Lenitral solution for intravenous injection and for intravenous perfusion
`Natispray
`Nitriderm TTS
`Trinipatch
`Trinitrine Simple Laleuf
`Trinitrine Cafeinee Dubois
`
`Tripalmitin
`Survanta
`
`Triphosadenine
`Atepadene (Sodium)
`Betriphos-C (Sodium)
`Myoviton (Sodium)
`Rhinatp (Sodium)
`
`Triprolidine
`Actifed (Hydrochloride)
`Actifed Dry Cough (Hydrochloride)
`
`Triptoreline
`Decapeptyl
`Decapeptyl sustained-release (Embonate)
`
`Tritoqualine
`Hypostamine
`
`Trometamol
`Almide
`Monuril (Fosfomycin)
`Thamacetat
`Uridoz (Fosfomycin)
`
`Tropatepine
`Lepticur (Hydrochloride)
`Lepticur Park (Hydrochloride)
`
`Topicamide
`Mydriaticum
`Tropicamide Faure
`
`
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`Tropisetron
`Navoban (Hydrochloride)
`
`Troxerutin
`Rheoflux
`Veinamitol
`Ginkor
`Ginkor Fort
`Rheobral
`Vivene
`
`Tuaminoheptane
`Rhinofluimucil (Sulfate)
`
`Tyrothricin
`Codetricine
`A 313 ointment
`Broncorinol Rhinites solution for nasal spray
`Bronpax chewing gum
`Codetricine sugar-free Vitamin C
`Collunovar sec
`Solutricine Tetracaine
`Solutricine Vitamin C
`Tyrcine
`Veybirol-Tyrothricine
`
`Urapidil
`Eupressyl gel capsule
`Eupressyl solution for intravenous injection and for intravenous perfusion
`(Hydrochloride)
`Mediatensyl gel capsule (CC)
`
`Urate oxydase
`Uricozyme
`
`Urea
`Bicnu
`Hydrea
`Kinurea H (Dihydrochloride)
`Amycor onychoset
`Keratosane
`
`Uridine
`Uteplex (Trisodium triphosphate)
`Vitacic
`
`Urofollitropin
`Fertiline
`Metrodin HP
`
`
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`
`Urokinase
`Actosolv Urokinase
`Urokinase Choay
`
`Valaciclovir
`Zelitrex (Hydrochloride)
`
`Valeriane
`Elusanes Valeriane
`Noctaval
`Relaxine
`Valeriane Boiron
`Actisane sleep disorders
`Anxoral
`Biocarde
`Confocalm oral solution Ad (CC)
`Euphytose
`Fluon
`Neuroflorine
`Neurotensyl
`Noctisan
`Palpipax
`Phytocalm
`Sedalozia
`Sedibaine
`Serenival
`Spasmidenal Jolly
`Spasmine
`Spasmine Jolly
`Sympaneurol
`Tisane sedative Weleda [sedative herbal tea]
`Tranquital
`Valerbe
`
`Valpromide
`Depamide
`
`Valsartan
`Tareg
`
`Vancomycine
`Vancocine (Hydrochloride)
`Vancomycine Dakota Pharm (Hydrochloride)
`Vancomycine Lederle (Hydrochloride)
`
`Veralipride
`Agreal
`
`Verapamil
`Isoptine (Hydrochloride)
`
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`Isoptine sustained-release (Hydrochloride)
`Novapamyl sustained-release (Hydrochloride)
`Verapamil Bayer sustained-release (Hydrochloride)
`Verapamil MSD sustained-release (Hydrochloride)
`
`Veratrol
`Lini-Bombe Thépénier
`Synthol
`
`Vidarabine
`Vira-MP (disodium phosphate)
`
`Vigabatrine
`Sabril
`
`Viloxazine
`Vivalan (Hydrochloride)
`Vivalan sustained-release (Hydrochloride)
`
`Vinblastine
`Velbe (Sulfate)
`
`Vinburnine
`Cervoxan
`
`Vincamine
`Pervincamine
`Vinca
`Vinca Retard
`Vincafor
`Rheobral
`Vincarutine
`
`Vincristine
`Oncovin (Sulfate)
`Vincristine Pierre Fabre (Sulfate)
`
`Vindesine
`Eldisine (Sulfate)
`
`Vinorelbine
`Navelbine (Ditartrate)
`
`Vitamin A
`See: Retinol
`
`Vitamin A acid
`See: Tretinoine
`
`Vitamin B1
`
`Lilly Ex. 2032 pg. 14
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`
`See: Thiamine
`
`Vitamin B12
`See: Cyanocobalamin
`See: Hydroxocobalamin
`
`Vitamin B2
`See: Riboflavin
`
`Vitamin B3
`See: Nicotinamide
`
`Vitamin B5
`See: Pantothenic acid
`See: Dexpanthenol
`
`Vitamin B6
`See: Pyridoxine
`
`Vitamin B8
`See: Biotin
`
`Vitamin B9
`See: Folic acid
`
`Vitamin C
`See: Ascorbic acid
`
`Vitamin D2
`See: Calciferol
`See: Ergocalciferol
`
`Vitamin D3
`See: Colecalciferol
`
`Vitamin E
`See: Tocopherol
`
`Vitamin H
`See: Biotin
`
`Vitamin K1
`See: Phytomenadione
`
`Vitamin K3
`See: Menadione
`
`Vitamin PP
`See: Nicotinamide
`
`
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`Warfarin
`Coumadine (Sodium)
`
`Xibornol
`Nanbacine gel capsule Ad
`Nanbacine oral suspension Children/Infants
`Nanbacine suspension for oral spray
`
`Xipamide
`Chroexan
`Lumitens
`
`Xylene
`Cerulyse
`
`Yohimbine
`Yohimbine Houdé (Hydrochloride)
`
`Zalcitabine
`Hivid
`
`Zidovudine
`Retrovir
`
`Zinc
`Granions de Zinc (Gluconate)
`Lanofene (Oxide)
`Oligogranul Zinc (Gluconate)
`Oligosol Zinc (Gluconate)
`Oligostim Zinc (Gluconate)
`Oxiplastine (Oxide)
`Rubozinc (Gluconate)
`Aguettant injectable zinc (Gluconate)
`Zymizinc (Gluconate)
`Agathol balm (Oxide)
`Aloplastine (Oxide)
`Aminomix 1 (Chloride)
`Aminomix 2 (Chloride)
`Anoreine (Oxide)
`Anusol (Oxide)
`Azedavit (Oxide)
`Azinc complexe (Oxide)
`Bebia (Oxide)
`Betaselen (Pidolate)
`Bioxyol (Peroxide)
`Brulex (Oxide)
`Carencyl (Oxide)
`Collunovar sec (Bacitracin)
`Deflamol (Oxide)
`Dermo-Sulfuryl (Sulfate)
`
`Lilly Ex. 2032 pg. 16
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`Dermocuivre (Oxide)
`Ektogan (Oxide, Peroxide)
`Elevit Vitamin B9
`Eryteal (Oxide)
`Therica calamine gel (Oxide)
`Halivite (Oxide)
`Heptan (Gluconate)
`Inotyol (Oxide)
`Endopancrine Insulin (Chloride)
`NPH highly purified crystallized Protamine Endopancrine Insulin - (Chloride)
`Highly purified Protamine Zinc Endopancrine Insulin (Chloride)
`Insuman 15/85 intermediate Insulin (Chloride)
`Insuman 15/85 intermediate Insulin for Optipen (Chloride)
`Insuman 25/75 intermediate Insulin (Chloride)
`Insuman 25/75 intermediate Insulin for Optipen (Chloride)
`Insuman 50/50 intermediate Insulin (Chloride)
`Insuman 50/50 intermediate Insulin for Optipen (Chloride)
`Insuman NPH intermediate Insulin (Chloride)
`Insuman NPH intermediate Insulin for Optipen (Chloride)
`Orgasuline 30/70 Insulin (Chloride)
`Orgasuline NPH Insulin (Chloride)
`Highly purified Organon Semi-Tardum Insulin (Chloride)
`Highly purified Organon MX Tardum Insulin (Chloride)
`Highly purified Organon Ultra-Tardum Insulin (Chloride)
`Insuline Umuline Zinc (Oxide)
`Insuline Umuline Zinc (Oxide)
`Insuline Umuline Zinc composé
`Lofenalac Mead Johnson
`Mitosyl (Oxide)
`Mycodecyl cream (Undecylenate)
`Mycodecyl powder for local application (Undecylenate)
`Nestosyl ointment (Oxide)
`Nonan (Gluconate)
`Oligo-éléments Aguettant (Gluconate)
`Oligo-éléments Lehning Femiplexe (Gluconate)
`Oligogranul Zinc-Cuivre [Zinc-Copper] (Gluconate)
`Oligogranul Zinc-Nickel-Cobalt (Gluconate)
`Oligosol Zinc-Cuivre (Gluconate)
`Oligosol Zinc-Nickel-Cobalt (Gluconate)
`Oligostim Zinc-Cuivre (Gluconate)
`Oligostim Zinc-Nickel-Cobalt (Gluconate)
`Oropivalone-Bacitracine (Bacitracine)
`Oxyperol (Oxide)
`Oxythyol (Oxide)
`Paps (Oxide, Undecylenate)
`Roche-Posay Water Paste (Oxide)
`Pharmaton (Oxide)
`Plenyl (Sulfate)
`Pygmal (Carbonate, Oxide)
`Quotivit O.E. (Oxide)
`
`Lilly Ex. 2032 pg. 17
`Sandoz v. Lilly IPR2016-00318
`
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`
`Ramet Acide (Sulfate)
`Ramet Dalibour Acide (Sulfate)
`Sénophile (Oxide)
`Stimuplexe (Gluconate)
`Supradyne (Sulfate)
`Survitine (Oxide)
`Synacthène Retard
`Synergyl (Oxide)
`Titanoréïne (Oxide)
`Vivamyne (Oxide)
`Yse (Phosphide)
`Yse glutamique (Phosphide)
`Zédène C (Sulfate)
`Zinc-Nickel-Cobalt Microsol (Pidolate)
`
`Zolpidem
`Ivadal (Hemitartrate)
`Stilnox sored coated tablet Ad (Hemitartrate) (CC)
`
`Zopiclone
`Imovane
`
`Zuclopenthixol
`Clopixol (Hydrochloride)
`Clopixol Prolonged Action (Decanoate)
`Clopixol Semi-Prolonged Action (Acetate)
`
`Lilly Ex. 2032 pg. 18
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`
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`
`*VITAMINE A DULCIS ®
`Retinol
`
`FORMS and PRESENTATIONS
`Ophthalmic ointment: 10g Tube (painted aluminum)
`
`
`COMPOSITION
`Retinol (ICD) or synthetic vitamin A,
`oily concentrate
`Excipients: lanoline, liquid paraffin,
`vaseline
`
`per 100g
`
`25,000 UI
`
`per tube
`
`2,500 UI
`
`
`DC INDICATIONS
`Conjunctival and corneal xerosis.
`Adjunctive treatment for corneal scarring disorders.
`
`DC DOSAGE and METHOD OF ADMINISTRATION
`Apply the equivalent of a grain of rice in the conjunctival sac 2 or 3 times a
`day.
`To do this, pull the eyelid downwards whilst looking upwards and apply the
`ointment between the eyelid and eyeball.
`
`DC CONTRAINDICATIONS
`Hypersensitivity to one of the ingredients in the ointment.
`
`DC WARNINGS and PRECAUTIONS FOR USE
`In the event of concomitant treatment with a collyrium, space the instillations 15
`minutes apart.
`
`DC INTERACTIONS
`Drug Interactions:
`The effectiveness of the ophthalmic ointment may be affected by the
`simultaneous instillation of a collyrium (see Warnings and Precautions for Use).
`
`DC PREGNANCY and BREASTFEEDING
`Pregnancy:
`The systemic distribution of vitamin A from this topical form is negligible. There
`are currently insufficient numbers of exposed pregnancies to assess a possible
`effect of vitamin A administered locally.
`Consequently, as a precaution, it is preferable not to use this medication during
`pregnancy.
`
`DC DRIVING and OPERATING MACHINERY
`Vision may be blurred a few moments after applying the ointment making
`driving a vehicle or operating machinery dangerous.
`
`PP PHARMACODYNAMICS
`Medication for ophthalmic use and curative therapy.
`(S: sense organs).
`
`MA 311 344.3 (1954, approved in 1997)
`
`Lilly Ex. 2032 pg. 19
`Sandoz v. Lilly IPR2016-00318
`
`

`
`PRICE: 11.20 F (10g tube).
`65% Social Security reimbursement. Collect.
`Laboratoires ALLERGAN FRANCE SA
`PO Box 442, Sophia Antipolis, 06251 Mougins Cedex
`Tel. 04 92 92 44 00
`__________________________
`
`
`*VITAMINE A FAURE ®
`Retinol
`
`FORMS and PRESENTATIONS
`Collyrium in solution: 10ml (PE) bottle
`
`
`COMPOSITION
`Retinol (ICD)........................................
`(in the form of water-dispersible
`synthetic vitamin A)
`
`per 100ml
`150,000 UI
`
`
`per bottle
`15,500 UI
`
`
`
`Excipients: 35 hydrogenated castor oil (Cremophor EL), glycerol, anhydrous
`sodium hydrogen phosphate, sodium hydrogen phosphate dodecahydrate,
`sodium edetate, purified water. Preservative: benzalkonium chloride.
`
`DC INDICATIONS
`Conjunctival and corneal xerosis.
`Adjunctive treatment for corneal scarring disorders.
`
`DC DOSAGE and METHOD OF ADMINISTRATION
`Ocular instillation.
`1 to 2 drops of collyrium, 3 to 6 times a day.
`Instill 1 to 2 drops into the lower conjunctival sac of the affected eye or eyes
`whilst looking upwards and gently pulling the lower lid downwards.
`Do not touch the eye or lids with the nozzle of the bottle.
`Replace the cap on the bottle after use.
`
`DC CONTRAINDICATIONS
`Hypersensitivity to one of the ingredients of the collyrium.
`
`DC WARNINGS and PRECAUTIONS FOR USE
`The collyrium must not be administered by peri- or intraocular injection.
`In the event of concomitant treatment with another collyrium, space the
`instillations 15 minutes apart.
`In the event of worsening of symptoms, the course of action must be
`reassessed.
`Soft (hydrophilic) contact lenses must not be worn during the treatment due to
`the risk of adsorption of the preservative (benzalkonium chloride).
`
`DC INTERACTIONS
`Drug Interactions:
`The effectiveness of a collyrium may be affected by the simultaneous instillation
`of another collyrium (see Warnings and Precautions for Use).
`
`
`Lilly Ex. 2032 pg. 20
`Sandoz v. Lilly IPR2016-00318
`
`

`
`PP PHARMACODYNAMICS
`Medication for ophthalmic use and curative therapy.
`(S: sense organs).
`
`DP SPECIAL STORAGE CONDITIONS
`To be kept away from light.
`After opening: 15 days
`
`MA 338 618.7 (1961, approved in 1997)
`PRICE: 13.00 F (10ml bottle).
`65% Social Security reimbursement.
`License holder: Ciba Vision Ophthalmics
`Distributor:
`
`Laboratoires THÉA
`12, rue Louis-Blériot, ZI du Brézet, BP 72 Saint-Jean 63016 Clermont-Ferrand
`Cedex 1
`Pharmacovigilance:
`Tel, 04 73 98 14 36 Fax: 04 73 98 14 38
`PHARMATHÉA
`12, rue Louis-Blériot, ZI du Brézet, BP 84 Saint-Jean 63016 Clermont-Ferrand
`Cedex 1
`Tel, 04 73 98 73 00 Fax: 04 73 98 73 09
`
`
`__________________________
`
`
`*VITAMINS B1-B6 ROCHE
`Thiamine, Pyridoxine
`
`
`FORMS and PRESENTATIONS
`(White) coated tablet: Tubs of 20 and 40.
`Hospital Pack: Box of 100
`
`COMPOSITION
`Thiamine (ICD) or vitamin
`B1...............................................
`Pyridoxine (ICD) Hydrochloride
`or vitamin B6................................
`
`
`250mg
`
`250mg
`
`per tablet
`
`per tub
`
`of 20
`5g
`
`5g
`
`of 40
`10g
`
`10g
`
`
`Excipients: polyvidone, talc, magnesium stearate, cellulose acetophthalate,
`hydrogenated castor oil.
`
`DC INDICATIONS
` Prophylaxis and treatment of Group B vitamin deficiencies whether of
`nutritional or iatrogenic origin in combination with the other vitamins of this
`group.
` Suggested for alcoholism in all its forms and for detoxification programs.
` Used in strong doses for rheumatic or neurological pain symptoms.
`
`
`DC DOSAGE and METHOD OF ADMINISTRATION
`
`Lilly Ex. 2032 pg. 21
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`
`

`
`1 to 4 tablets per day. To avoid the disagreeable odor of the powder coating,
`the tablets should be swallowed without chewing or crushing.
`
`DC WARNINGS and PRECAUTIONS FOR USE
`Vitamin B6 stimulates peripheral dopa-decarboxylase. Consequently, Vitamin
`B6 must not be administered with Levodopa unless the latter is associated
`with a dopa-decarboxylase inhibitor. Do not exceed the dose of 2g of vitamin
`B6 per day (see Undesirable Effects).
`
`DC UNDESIRABLE EFFECTS
`Rare cases of allergy. Some peripheral neurological manifestations,
`particularly paresthesia, have been reported after taking high doses of vitamin
`B6 (2 to 3g per day) over a prolonged period.
`
`
`PP PHARMACODYNAMICS
`Actions in protein, carbohydrate and fat intermediate metabolisms. Vitamin B1
`plays an important role in the production of the energy needed for cellular
`metabolic requirements (Krebs cycle, pentose pathway and synthesis of
`acetylcholine). Vitamin B6 is the coenzyme of tens of enzymatic reactions; it is
`involved in the formation of serotonin and vitamin PP and in the synthesis of
`GABA.
`
`PP PHARMACOKINETICS
`Thiamine, reabsorbed into the upper part of the duodenum, is carried to the
`liver via the portal vein. Thiamine is found in all tissues, but tissue reserves are
`never large.
`After having played its role in the prosthetic group in the form of cocarboxylase,
`thiamine is degraded and the metabolites are eliminated through the renal
`route.
`When it is administered in large quantities, thiamine can be found in an
`unchanged form in urine or sweat.
`Vitamin B6 is rapidly reabsorbed and elimination is mainly via the urinary route.
`
`MA 311 398.6 (1960) 20 tablets
` 329 569.7 (1987) 40 tablets
` 553 308.9 (1992) 100 tablets
`Indicative PRICE: 24.10 F (20 tablets)
` 41.30 F (40 tablets)
`No Social Security reimbursement. Collect. (20 and 100 tablets)
`PRODUITS ROCHE
`52, bd du Parc, 92521 Neuilly-sur-Seine cedex
`Tel. 01 46 40 50 00
`__________________________
`
`
`*VITAMINE B6 RICHARD ®
`pyridoxine
`
`FORMS and PRESENTATIONS
`(White) scored tablet: Box of 20
`
`
`COMPOSITION
`
`per tablet
`
`per box
`
`Lilly Ex. 2032 pg. 22
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`
`Pyridoxine (ICD)
`Hydrochloride............
`
`250mg
`
`5g
`
`
`Excipients: lactose, sucrose, starch, magnesium stearate.
`
`DC INDICATIONS
`Prophylaxis and treatment of vitamin deficiencies due to reduced food intake,
`most often in combination with the other group B vitamins.
`Treatment and prophylaxis of neuropathies due to certain medications such as
`Isoniazid.
`
`DC DOSAGE and METHOD OF ADMINISTRATION
`Adults: 1/4 to 4 tablets per day for 20-day treatments, separated by a rest
`period.
`Children: 1/4 to 2 tablets per day, depending on age.
`
`DC WARNINGS and PRECAUTIONS FOR USE
`Do not combine vitamin B6 with Levodopa, unless this is combined with a
`dopadecarboxylase inhibitor.
`
`DC INTERACTIONS
`Drug Interactions:
`Vitamin B6 inhibits the action of Levodopa (stimulation of peripheral
`dopadecarboxylase).
`
`DC UNDESIRABLE EFFECTS
`At high doses, taking vitamin B6 for a prolonged period may cause certain
`peripheral neurological manifestations.
`
`PP PHARMACODYNAMICS
`Vitamin B6 acts in its active form, pyridoxal phosphate. It is involved in
`numerous enzymatic reactions.
`In the event of deficiency, the clinical manifestations are as follows: dermatitis,
`microcytic and hypochromic anemia, convulsions and peripheral neuropathy.
`Vitamin B6 deficiencies are rarely isolated but most often associated with group
`B vitamin deficiencies.
`
`PP PHARMACOKINETICS
`Pyridoxine hydrochloride is rapidly reabsorbed and elimination is initially
`urinary.
`
`MA 319 382.1 (1960)
`No Social Security reimbursement.
`License holder: Ciba Vision Ophthalmics
`Distributor:
`
`Laboratoires M. RICHARD SA
`26740 Sauzet
`Tel: 04 75 46 70 30 Fax:04 76 46 70 66
`__________________________
`*VITAMINE B12 AGUETTANT ®
`
`Lilly Ex. 2032 pg. 23
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`

`
`pyridoxine
`
`FORMS and PRESENTATIONS
`100 μg/ml Intramuscular injectable solution: 1ml vials, boxes of 10 and 100.
`1,000 μg/2ml Intramuscular injectable solution: 2ml vials, boxes of 10 and 100
`
`
`COMPOSITION
`Per vial:
`Cyanocobalamine (ICD) or vitamin
`B12.........
`
`
`1ml
`100μg
`
`
`2ml
`1,00μg
`
`
`Excipients: sodium chloride, concentrated hydrochloric acid qs, pH 4 to 5.5,
`WFI
`
`DC INDICATIONS
`Proven vitamin B12 deficiencies due to an absorption defect: Biermer’s disease,
`total gastrectomy, resection of the terminal ileum and Imerslund’s disease.
`
`DC DOSAGE and METHOD OF ADMINISTRATION
`Intramuscular injectable route.
`Maintenance treatment: one vial per month via intramuscular injection. Some
`forms come in 1,000μg doses, which are more appropriate for initial treatment.
`
`DC CONTRAINDICATIONS
` History of allergy to cobalamins (vitamin B12 and related substances)
` Malignant tumor: due to the action of vitamin B12 on the growth of tissues
`with a high rate of cellular multiplication, the risk of exacerbation must be
`taken into account
`
`
`DC UNDESIRABLE EFFECTS
` Allergic reactions: pruritus, urticaria, eczema, erythema and oedema that
`may be severe: anaphylactic shock, cutaneous necrosis or Quincke’s
`oedema
` Risk of acne
` Possibility of pain at the injection site
` Red coloration of urine (corresponding to the urinary elimination of vitamin
`B12).
`
`
`PP PHARMACODYNAMICS
`Antianemic, vitamin B12 (B: blood and hematopoietic organs).
`Cyanocobalamine: hematopoietic factor
`
`PP PHARMACOKINETICS
`Vitamin B12 is absorbed through the terminal ileum after an enterohepatic cycle.
`It is carried through the bloodstream by transcobalamins. Excretion is urinary
`at high doses and mainly biliary at low doses.
`
`DP INCOMPATIBILITIES
`The pH stability