COMMISSION DECISION of 17 March 2009 requiring Member States to ensure that products containing the biocide dimethylfumarate are not placed or made available on the market (notified under document number C(2009) 1723) (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES,DMF was most often contained in little pouches fixedinside the furniture or added to the footwe
0-census.gov.iii-server.ualr.eduM A 325G — PH A R M A C EU TIC AL PR EPA R ATIO N S EX C EPT BIO LO G IC ALS (M A N U FA CTU R ER S) D EFIN ITIO N S AN D SPECIA L IN STR U CTIO N S Products bought and resold w ithout furtherm anufacture should not be included in shipm ents.
This survey covers manufacturers of pharm aceuticalpreparations, except biologicals, in the United States, Establishm ents shipping dosage form s, in bulk and and includes all preparations w hich can be dispensed in requiring repackaging, to other establishm ents of the m easured portions to produce the therapeutic effect for same company, should report in colum n (4) a transfer w hich the preparation is most com m only em ployed value reflecting only services or operations perform ed (liquids, tablets, pills, capsules, lozenges, pow ders, including profit (or loss) norm ally assigned to the ointm ents, jellies, salves, inhaler tubes, etc.). Products m anufacturing establishm ent. For plants shipping m anufactured in Puerto Rico or other U.S. possessions sim ilar products to other com panies for repackaging report in colum n (4) dosage form s shipped in bulk atnet sales value as defined above.
Com m ercial shipm ents (packaged for consumer use) Com panies w ith more than one establishm ent Report the value of each drug product produced m anufacturing the products covered by this survey are in dosage form , packaged for consum er use and requested to com plete a separate report form for each shipped from this establishm ent to sales branches, location. If you have not received a separate form for w arehouses of your com pany, w holesale or retail each of your establishm ents, please call the contact stores, and other com m ercial custom ers such as listed on the report form or w rite to the U.S. Census Contract operations include shipm ents of products Operations for w hich data should be reported include: m ade for others from your own materials. Exclude M anufacturing drugs in packaged dosage form for receipts for capsulating and/or packaging of preparations owned by others; com panies for w homsuch work is done should report value of shipm ents of M anufacturing drugs in dosage form and shipping in "bulk" type containers for repackaging or for export Com pounding pharm aceutical preparations andshipping dosage form s in "bulk" Report values in thousands of dollars.
Please exam ine the reference list to determ ine w hich of the listed pharm aceuticals are produced by you. If youare unable to find a specific line w hich describes a drug W hen posting your figures to the original report, be product, include this product in the not elsew here sure to report the inform ation in the correct colum ns.
classified (n.e.c.) product category at the end of theproduct grouping w ith w hich it is m ost closely Colum n 1 (Total) — Report the sum of colum ns 2 associated. In the "n.e.c." products categories, a separate line should be used to describe and report eachm ajor product. Describe each "n.e.c." product by using Colum n 2 (Prescription legend) — Report the value of com m on com m ercial nam e, generic name, or other each drug product w hich by Federal Law is available specific nam e, and enter any other nam e, description, or only by prescription from a licensed practitioner.
use that w ill help to classify the product using the"Remarks" section for additional space if necessary.
Colum n 3 (Non-prescription) — Report the value ofeach non-prescription drug product shipped.
Colum n 4 (Bulk shipm ents) — Report the value of Report total value of shipm ents of each each drug product shipped in dosage form s, or in bulk, pharm aceutical preparation sold, transferred to other establishm ents w ithin your com pany, or shipped onconsignm ent, w hether for dom estic or export sale. N ote: Export shipm ents are to be included in these Value represents the net sales price, f.o.b. plant, to the custom er or branch to which the products are shipped,net of discounts, allow ances, freight charges, and returns. Shipm ents to your own branches should beassigned the sam e value as com parable sales to The product detail for this survey, as shown in the unaffiliated custom ers, i.e., the value includes an Reference List is defined according to standard appropriate allocation of com pany overhead and profit.
DEFINITIONS AND SPECIAL INSTRUCTION — Continued Data reported in this survey should correspond to data reported in the Annual Survey ofM anufactures Form. The sum of values for item codes show n in colum n (a) should correspond tothe dollar values reported under product codes indicated in colum n (b) below : FORM M A 32 5 G PH A R M A C EU T IC A L PR EPA R AT IO N S EX C EPT BIO LO G IC A LS (M A N U FA C T U R ER S ) PH A R M A CEU TICA L PR EPAR A TIO N S AFFEC TIN G N EO PLAS M S , END O CR IN E SY S TEMA N D M ETA BO LIC D IS EA S ES , FO R H U M A N U SE Corticoids, such as cortisone, desoxycorticosterone, hydrocortisone, and prednisone, including system ic, local and topical (including anti-infective com binations) Androgens, except anabolic agents, such as fluoxymesterone and m ethyltestosterone Insulins and anti-diabetic agents such as glucagon and sulfonylureas Oral contraceptive preparations (Report vaginal contraceptives in code 325412D191) Progestogens, such as ethisterone and progesterone (Report prem enstrual tension preps incode 325412D193) Thyroid and antithyroid preparations, such as iodides and propylthiouracil Anabolic agents (synthetic and sem isynthetic androgens em ployed prim arily for anabolicactivity), such as nandrolone phenpropionate and norethandrolone Other horm one preparations, such as chorionic gonadotropin, parathyroids,andvasopressin, ACTH (corticotropni), and Sex horm one com binations (exceptprogestogen com binations) Anti-neoplastic agents, including busulfan, chlorambucil, cyclophospham ide, vincristineand antim etabolites (folic acid, purine, and glutam ine antagonists), and Radioactiveisotopes for internal use O ther pharm aceutical preparations affecting neoplasm s, the endocrine system andm etabolic diseases such as m etabolic agents, parenteral fats, carbohydrates, and proteinpreparations TO TA L, PH AR M A CEU TICA L PR EPA R A TIO N S AFFECTIN G N EO PLA S M S , EN D O CR IN ES Y STEM A N D M ETA BO LIC D IS EA S ES , FO R H U M A N U SE PH AR M A CEU TICA L PR EPA R A TIO N S ACTIN G O N TH E CEN TR A L N ER V O US SY STEM A N DTH E SEN S E O R GA N S , FO R H U M A N U SE Parasym pathom im etic cholinergic drugs (agents em ployed mainly for treatm ent ofm yasthenia gravis) such as am benonium , neostigm ine, and pyridostigm ine S keletal m uscle relaxants such as m ethocarbamol and m etaxalone Internal analgesics and antipyretics (Report external analgesics in codes 325412G146 to325412G161) Narcotic, such as alphaprodine, meperidine, m ethadone, and m orphine PH AR M A CEU TICA L PR EPA R A TIO N S ACTIN G O N TH E CEN TR A L N ER V O US SY STEM A N DTH E SEN S E O R G A N S , FO R H U M A N U S E — Continued Internal analgesics and antipyretics (Report external analgesics in codes 325412G146 to 325412G161) — Continued Salicylates, including Aspirin (acetylsalicylic acid), and others such as sodium salicylate Anti-arthritics and anti-inflamm atory agents (non-horm onal), such as flunisolide and fluorom etholone Other internal analgesics and antipyretics including effervescent types and suppositories, such as acetophenetidin, and ethoheptazine A nticonvulsants, except barbiturates and analogs (For treatm ent of petit m al, grand m al,psychom otor and focal epilepsy) such as phenytoin, ethotoin, paramethadione, andm ethsuxim ide Antidepressants (for treatm ent of pyschoneurotic depression, involutional m elancholia, the depressive phase of m anic-depressive psychosis and the depression of schizophrenia), such as im ipram ine hydrochloride, isocarboxazid, and m aprotiline Tranquilizers (for treatm ent of em otional instability and anxiety-tension states) Report sedatives in codes 3254124171 to 3254124181 Phenothiazine derivatives, such as prom azine, prochlorperazine, and thioridazine Other tranquilizers, such as chorprothixene and molindone Central nervous system stim ulants, including am phetam ine, anorexiants containing CN S stim ulants such as phenylpropanolam ine hydrochloride, except am phetam ines (R eport diet aids containing local anesthetics in code 325 4124189), and other, (respiratory and cerebral stim ulants, including sym pathom im etic agents em ployed m ainly as CN S stim ulants) (exclude nondrug dietaries for w eight control) PH AR M A CEU TICA L PR EPA R A TIO N S ACTIN G O N TH E CEN TR A L N ER V O US SY STEM A N DTH E SEN S E O R G A N S , FO R H U M A N U S E — Continued S edatives, anxiolytics and hypnotics (products prim arily used for sedation) (Report productscom bined with sedative agents under the prim ary therapeutic indication) Barbiturates, such as am obarbital, butabarbital, pentobarbital, and phenobarbital Non-barbiturates, such as ethchlorvynol, glutethim ide, and m ethyprylon .
Non-prescription sleep inducers (excluding antihistamines), and calm ing agents such A nesthetics except urinary tract anesthetics and antipruritic skin preparations, includinggeneral, local, and topical, such as proparacaine, piperocaine, benoxinate, andethylam inobenzoate (Report urinary tract anesthetics in code 325412D 196, andantipruritics in code 325412G116) Eye and ear preparations (excluding anti-infectives corticoids, anti-bacterials andantiseptics) (Report antibiotics, sulfonamides, and other anti-infectives in codes325412P111 to 325412P174; local and topical corticoid preparations in code3254121116; and anti-bacterials and antiseptics including m outhw ashes and gargles incodes 325412P177 and 325412P181) Other eye and ear preparations, including m ydriatics and m iotics Other pharm aceutical preparations acting on the central nervous system and the senseorgans TO TA L, PH AR M A CEU TICA L PR EPA R A TIO N S ACTIN G O N TH E CEN TR A L N ER V O USS Y STEM A N D TH E SEN S E O R GA N S , FO R H U M A N U SE PH AR M A CEU TICA L PR EPA R A TIO N S ACTIN G O N TH E CA R D IO V AS CU LA R SY STEM , FO RH U M A N U SE A nticoagulants (for the prophylaxis and treatm ent of intravascular clotting, throm bophlebitispulm onary em bolism , arterial throm boses, and coronary occlusion) such as anisindione,heparin, and w arfarin, hem ostatics (for control of capillary, venous, or arterial bleeding)such as throm bin and aminocaproic acid), and digitalis preparations such as digitalis,digitoxin, and digoxin PH AR M A CEU TICA L PR EPA R A TIO N S ACTIN G O N TH E CA R D IO V AS CU LA R SY STEM , FO RH U M A N U S E — Continued Hypotensives such as guanethidine, hydralazine, and m ethyldopa, rauw olfia-alkaloidpreparations such as reserpine and rescinnam ine, and rauw olfia-diuretic com binations, andbeta receptor blocking agents, such as propanolol hydrochloride Coronary (for treatm ent of angina pectoris) including am ylnitrite, erythrityl tetranitrate,and pentaerythritol tetranitrate, and peripheral (for relief of vasospasm ) includingisoxuprine and cyclandelate Anti-arrhythm ics, such as propanolol and quinidine Calcium channel blockers such as isoptin, calan, procardia, cardizem and adalat Ace inhibitors such as vasotec, capoten, prinivil and zestril O ther pharm aceutical preparations acting on the cardiovascular system includingvasopressors, and antiheparin agents TO T AL, PH A R M A C EU TIC AL PR EPA R ATIO N S A CTIN G O N TH E CA R D IO V A S CU LA RS Y STEM , FO R H U M A N U SE PH AR M A CEU TICA L PR EPA R A TIO N S ACTIN G O N TH E RES PIR A TO RY S Y STEM , FO RH U M A N U SE A ntihistam ines, except cold preparations and anti-em etics such as brom pheneram ine,diphenhydram ine, diphenylpyraline, and chlorpheneram ine m aleate, and bronchial dilatorsincluding antiasthm atics (for the relief of bronchial spasm or congestion such astheophylline Cough and cold preparations (prescription) Cough preparations and expectorants (containing an antitussive or other ingredientintended prim arily to treat cough only), including non-narcotic, and narcotic such asbenzonatate, glycerylguaiacolate, terpin hydrate, codeine, and hydro codeine Cold preparations (containing com binations of the follow ing ingredients, (but noantitussive) nasal decongestant, antihistamine, analgesic, bioflavanoid, or antibiotic) Antihistamine cold preparations, such as tripelennam ine and cyproheptadine Other prescription cold preparations, including nasel decongestants, such asproplhexadrine Cough and cold com binations (prescription) PH AR M A CEU TICA L PR EPA R A TIO N S ACTIN G O N TH E RES PIR A TO RY S Y STEM , FO RH U M A N U S E — Continued Cough and cold preparations (non-prescription) Decongestants, including nasal sprays, nose drops, and others Other non-prescription cough and cold preparations, including topical preparations, andcough drops O ther pharm aceutical preparations acting on the respiratory system , including betaagonists such as proventil and ventolin TO T AL, PH A R M A C EU TIC AL PR EPA R ATIO N S A CTIN G O N TH E RES PIR A TO R Y PH AR M A CEU TICA L PR EPA R A TIO N S ACTIN G O N TH E D IG ES TIV E O R TH E GEN ITO -U R IN A R Y SY S TEM S , FO R H U M A N U SE Enzym es such as amylase, lipase, cellulase Antacids including acid neutralizing products and products w ith coating functions, butexcluding effervescent salicylate products classified as analgesics, such as alum inum -hydroxide, calcium carbonate, dihydroxy alum inum am inoacetate, and alum inum -phosphate (Report internal analgesics in code 3254124141), and antidiarrheals such asbism uth subcarbonate (except narcotics) Laxatives such as bisacodyl, cascara sagrada, castor oil, danthron, dioctyl sodiumsulfosuccinate, m agnesium sulfate, m ethylcellulose, sodium carboxymethylcellulose, andpetrolatum (liquid) PH AR M A CEU TICA L PR EPA R A TIO N S ACTIN G O N TH E D IG ES TIV E O R TH E GEN ITO -U R IN A R Y S Y S TEM S , FO R H U M A N U S E — Continued D igestive system preparations — Continued Antispasm odics and anticholinergics, including ataractic com binations, belladonna and derivatives, and H2 blocking agents such as zantec, tagam et, carafate, and pepcid Synthetics (such as adiphenine, anisotropine, dicyclom ine, and papaverine) Antispasm odics and anticholinergics, including ataractic com binations, belladonna and derivatives, and H2 blocking agents such as zantec, tagam et, carafate, and pepcid Other digestive system preparations including emetics such as ipecac, including Digestants; Bile therapy preparations including bile products, choleretics, and cholagogues; Antinauseants and m otion sickness remedies (anti-emetics) including antihistam inic anti-em etic preparations; Lipotropics and cholesterol reducers; and Diet aids containing local anesthetics such as benzocaine. (Report anorexiants containing CNS in codes 3254124165) Urinary antibacterials and antiseptics such as m ethenam ine m andelate, and nitrofurantoin Diuretics, including chlorthalidone, ethacrynic acid, and triampterene, thiazides and related agents such as chlorothiazide, hydrochlorothiazide, and hydroflum ethiazide (report am inophylline, xanthine, and rauw olfia-diuretic com binations ascardiovascular preparations) Oxytocics such as ergonovine and oxytocin Vaginal cleansers (Report trichom onacides in code 325412P111, fungicides in code325412P167, and antibacterials in code 325412P177) O ther pharm aceutical preparations acting on the genito-urinary system including urinarytract anesthetics, including prem enstrual tension preparations, and contraceptive agents(aerosols, jels, sponges, and cream s)(Report oral in code 3254121141) TO TA L, PH AR M A CEU TICA L PR EPA R A TIO N S ACTIN G O N TH E D IG ES TIV E O R TH EG EN ITO -U R IN A R Y SY S TEM S , FO R H U M A N U SE PH A R M A C EU TIC AL PR EPA R ATIO N S A CTIN G O N TH E SK IN , FO R H U M A N U SE Em ollients and protectives including burn rem edies and ointment bases Antipruritics and local anesthetic skin preparations (products used prim arily to alleviateitching), such as cyclom ethylcaine and benzocaine Antidandruff and antiseborrheic preparations, except dandruff sham poos Other derm atological preparations, including coal tar, sulfur, and resorcinol preparations External analgesics and counter irritants, including ointments, jellies, pastes, cream s,cerates, salves, liquids, and rubbing alcohol O ther pharm aceutical preparations acting on the skin TO T AL, PH A R M A C EU TIC AL PR EPA R ATIO N S A CTIN G O N TH E SK IN , FO R H U M A N U SE V ITA M IN , N U TR IEN T, A N D H EM A TIN IC PR EPA R ATIO N S , FO R H U M A N U SE M ultivitam ins, plain and w ith m inerals, except B com plex vitam ins and fish liver oils Pediatric vitamin preparations (drops, suspensions, and chew able tablets) All other vitamin preparations, including fluoride preparations (Report fluoride-vitamin com binations in applicable code 315412L116, 325412L121, or 325412L135) N utrients excluding therapeutic dietary foods and infant form ulas V ITA M IN , N U TR IEN T, AN D H EM A TIN IC PR EPA R A TIO N S , FO R H U M A N U S E — Continued Other hem atinics, including oral, and parenteral O ther vitam in, nutrient, and hem atinic preparations, including hospital solutions (including dextrose, dextran, etc., but excluding biologicals such as blood plasma) TO T AL, V ITA M IN , N U TR IEN T A N D H EM A TIN IC PR EPA R ATIO N S , FO R H U M A N U SE PH A R M A C EU TIC AL PR EPA R ATIO N S A FFEC TIN G PA R AS ITIC A N D IN FEC TIV E D IS EA S ES ,FO R H U M A N U SE A nti-infective agents (Report corticoid-anti-infective com binations in code 3254121116) Am ebicides and trichom onicides such as diiodohydroxyquin, em etine, m etronidiazole, andfurazolidone Anthelm intics (for roundw orm s, hookw orm s, pinw orm s, w hipw orm s, and tapew orm s)such as dithiazanine, hexylresorcinol, piperazine, and tetrachloroethylene Broad and medium spectrum (single or in com binations with other antibiotics) Tetracyclines, including chlortetracycline and congeners Cephalosporins, such as cefam andole nafate and cephalexin Sem isynthetic penicillins, such as am oxicillins and am picillin Other penicillins, injectable and other form s (except sem isynthetic), such aspenicillin V and penicillin G Other broad and medium spectrum antibiotics (except sulfa-antibiotic combinations) Antibiotics in com bination w ith sulfonamides Other systemic antibiotic preparations, including narrow -spectrum antibiotics and streptom ycins PH A R M A C EU TIC AL PR EPA R ATIO N S A FFEC TIN G PA R AS ITIC A N D IN FEC TIV E D IS EA S ES ,FO R H U M A N U S E — Continued A nti-infective agents (Report corticoid-anti-infective com binations in code 3254121116) —Continued Tuberculostatic agents, including isoniazid (isonicotinic acid hydrazide) preparations,aminoslicylic acid, capreom ycin, and cycloserine Antim alarials (plasm odicides) such as chloroquine, prim aquine, pyrim etham ine, and quinine Sulfonamides, such as sulfamerazine, sulfamethizole, and sulfadiazine (except sulfa-antibiotic combinations) Antifungal preparations such as iodochlorhydroxyquin Antivirals, system ic, such as zovirax and retrovir A ntibacterials and antiseptics (Report urinary preparations in code 325412D177, antibioticsin codes 325412P117 to 325412P151, and sulfonam ides in code 325412P164) M outh and throat preparations, including m outhw ashes and gargles O ther pharm aceutical preparations affecting parasitic and infective diseases TO TA L, PH AR M A CEU TICA L PR EPA R A TIO N S AFFECTIN G PA R A S ITIC AN D IN FECTIV ED IS EA S ES , FO R H U M A N U SE PH A R M A C EU TIC AL PR EPA R ATIO N S FO R V ETER IN A R Y U S E(Note: INCLUDE drug and vitamin pre-mixes for use in animal feeds; EXCLUDEsupplem ents, concentrates, and com plete feeds) Other antibiotics, including tetracyclines A ntiseptics, w ound dressings and fungicides H orm ones, including insulin, ACTH (corticotropin), and other horm one preparations PH A R M A CEU TICA L PR EPA R A TIO N S FO R V ETER IN A R Y U S E — Continued O ther pharm aceutical preparations for veterinary use, including vitam ins, m inerals,tranquilizers, ataractics, sulfonam ides, intravenous solutions, electrolytes, hem ostatics,and hem atinics TO T AL, PH A R M A C EU TIC AL PR EPA R ATIO N S FO R V ETER IN A R Y U S E
OMNI Nuvo Lithium EP No. 2 Material Safety Data Sheet CITGO Petroleum Corporation P.O. Box 3758 Hazard Rankings Tulsa, OK 74102-3758 Revision Date HMIS NFPA IMPORTANT: Read this MSDS before handling or disposing of this product and pass this Health Hazard information on to employees, customers and users of this product. Fire Hazard Emergency Overview Rea