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OTC & Biosimilar Directory 2010

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OTC & Biosimilar Directory 2010

  1. 1. OTC & Biosimilar See our Global Generic Licensing Directory for over Directory Supplement 7000 DOSSIERS or visit Edition 1, 2010 www.genericlicensing.com Please contact us now to receive a booking form Email: directory@genericlicensing.com or Phone: +44 8707524105 © Copyright 2008-2009
  2. 2. OTC & Biosimilar Directory Supplement OTC COMPANY LIST Services Offered FEATURED COMPANY Geiser Pharma ✔ Regulatory filings, variations and license maintenance ABC Farma ✔ Dossier creation, formatting and auditing (NTA, CTD, eCTD, ANDA) Biogened ✔ Manufacturing GMP inspection preparation Bioxtract Diapharm ✔ Manufacturing technical transfers EMS ✔ Formulation development projects Farmalider Helvetia Pharma Europe – North America – Australasia Oystershell Expertise is offered both in-house and through industry leading partners. Progressare Talk to us about your technical service requirements today. CALL +44 (0)870 7524105 CLIENT.CARE@GENERICLICENSING.COM Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.
  3. 3. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE FEATURED COMPANY: Geiser Pharma COMPANY NAME Geiser Pharma is a pharmaceutical company dedicated to developing both generic and Geiser Pharma OTC products purely to be out-licensed to third parties. Apart from our own developments, Geiser Pharma offers its partners the possibility to increase their R&D capacity through CITY outsourcing our R&D services, allowing partners to have access to value added Product name Carbocysteine Lysine Syrup Product name Pharma lozenges with Lidocaine Pamplona technologies. Category OTC Category OTC Ingredients 2,7 g Carbocysteine Ingredients 2,0 Lidocaine / 1,2 mg Dichlorobencilic COUNTRY Contact Preson: Lourine Lenderink (llenderink@geiserpharma.com) Use/Claim Mucolytic that reduces sputum viscosity Alcolhol / 0,6 mg Amylmetacresol Spain Contact Telephone Number: 0034 948 101943 / 0034 607 616 045 Main Indication Cough & Cold Use/Claim Pharma lozenges with topical anesthetic Unit Size 20 sachets / unit effect PACK SHOTS Status Under development Main Indication Sore throat relief Sold In (Countries) T.B.D. Unit Size ALU blister containing 24 lozenges Status Under development Sold In (Countries) T.B.D OTC PRODUCTS Product name Stick Pack Doxylamine Succinate Product name Stick Pack Ranitidine Product name Pharma lozenges Product name Vegetal Laxative Category OTC Category OTC Category OTC Category OTC Ingredients 12,5 / 25,0 mg Doxylamine Succinate Ingredients 75 / 150 mg Ranitidine Ingredients 1,2 mg Dichlorobencilic Alcolhol / 0,6 mg Ingredients Rhamnus Frangula, Rhamnus Pushianus, Use/Claim Night time sleep aid. Hygroscopic formulation Use/Claim Hygroscopic formulation that inhibits stomach Use/Claim Amylmetacresol Fucus Thallus which allows product to dissolve directly in acid production. No water needed. Pharma lozenges with topical anesthetic Use/Claim 100% vegetal laxative, indicated for diabetics the mouth. No water needed. Main Indication Heart burn effect Main Indication Constipation Main Indication Insomnia Unit Size 10 Alu Foil sticks / box. Pre-cut opening, Main Indication Sore throat relief Unit Size PVC / ALU blister containing 2 x 20 capsules Unit Size 10 Alu Foil sticks / box. Pre-cut opening, child proof. Stick size 70 x 23 mm Unit Size ALU blister containing 24 lozenges Type 0 child proof. Stick size 70 x 23 mm Status Under development Status Under development Status Available Status Under development Sold In (Countries) T.B.D. Sold In (Countries) T.B.D Sold In (Countries) T.B.D Sold In (Countries) T.B.D.
  4. 4. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name High Hyalplus Product name Ice Cold Pain Relief Patch Product name Hypertonic Sea Water Earspray Product name Earspray Special Babies Category Medical Device Category Medical Device Category Medical Device Category Medical Device Ingredients Injectable Sodium Hyaluronate 2 ml / 20 mg Ingredients Natural Menthol (5%) Ingredients Sea Water Ingredients Sea Water Use/Claim HA for pain relief and decreasing of synovium Use/Claim Pain relief cooling therapy Use/Claim Safest alternative to cotton buds for a regular Use/Claim Safest alternative to cotton buds for a regular inflammation. Main Indication Pain relief risk-free ear hygiene risk-free ear hygiene in young children Main Indication Pain relief Unit Size 5 patches in resealable pouch. Patch size Main Indication External auditory canal hygiene Main Indication External auditory canal hygiene Unit Size Prefilled syringes 10 x20 cm Unit Size 50 ml metallic flask, innovative nozzle Unit Size 50 ml metallic flask, innovative nozzle Status Available Status Available Status Available Status Available Sold In (Countries) T.B.D. Sold In (Countries) T.B.D. Sold In (Countries) T.B.D. Sold In (Countries) T.B.D. Product name Warming Patch Product name Hydrating vaginal gel Product name Icy Pads forehead cooling pads Children Product name Luteine + Multivitamin Soft Gel Capsules Category Medical Device Category Medical Device Category Medical Device Category Food supplement Ingredients Iron powder, activated carbon, water and salt Ingredients Cranberry / chamomile extract Ingredients Menthol oil, Lavender oil, Eucaluptus oil Ingredients Multivitamins + Luteine Use/Claim 8 hours of constant and penetrating heat that Use/Claim Pharma quality hydrating vaginal gel with Use/Claim Soothing cooling relief for fever discomfort & Use/Claim Soft gel capsules containing Luteine, relaxes tense and contracted muscles cranberry extract, paraben free. Reliefs headaches during 6 hours to children Main Indication vitamins and essential fatty acids Main Indication Pain relief vaginal dryness and facilitates sexual Main Indication Pain relief Sight Care Unit Size Patch size 15 x 10 cm / 22 x 10 cm. 2 intercourse. Unit Size 2 x 2 pads per unit. Pad size 5 x 12 cm. Unit Size Alu blister 2 x 15 / 4 x 15 soft gel capsules patches per unit Main Indication Female Hygiene Status Available Status Available Status Under development Unit Size Innovative dispenser with valve, 30 ml Sold In (Countries) T.B.D. Sold In (Countries) T.B.D. Sold In (Countries) T.B.D. Status Available Sold In (Countries) T.B.D.
  5. 5. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name Thermal Spring Water Tooth Paste Product name Thermal Spring Water Sensible Gums Product name Thermal Spring Water Tooth Paste Junior Product name Thermal Spring Water First Teeth Category Cosmetic Category Cosmetic Category Cosmetic Category Cosmetic Ingredients 1100 ppm Fluor Ingredients Thermal spring water Ingredients 1000 ppm Fluor Ingredients Spring water, Chamomile Use/Claim Thermal spring water tooth paste / 1100 ppm Use/Claim Toothpaste gel provides a gentle care for Use/Claim Specifically designed for children between 7 Use/Claim Thermal water teething gel with natural, Fluor sensitive gums, weakened teeth, or teeth with and 12 years old to prevent tooth decay in soothing and anti-irritating properties. Main Indication Dental Hygiene eroded enamel. Mentholated gel helps permanent teeth. Mint flavour. Marshmallow flavour. Chamomile extract. No Unit Size 75 ml Polyethylene tube HDPE reduce occasional bleedings and gingival or Main Indication Dental Hygiene sugar. No alcohol. dental sensitivities. No fluoride, paraben free. Unit Size 50 ml Polyethylene tube HDPE Main Indication Dental Hygiene Status Available Main Indication Dental Hygiene Available Unit Size 50 ml Polyethylene tube HDPE Sold In (Countries) T.B. D Status Unit Size 75 ml Polyethylene tube HDPE Status Available Sold In (Countries) T.B. D Status Available Sold In (Countries) T.B.D. Sold In (Countries) T.B.D. Product name Thermal Spring Water Tooth Whitener Product name Thermal Spring Water Mouth Spray Product name Greaseless Balsamic Decongestive Product name Thermal Spring Water Tooth Paste & Care Category Cosmetic Menthol Chest Rub Children Category Cosmetic Ingredients Thermal spring water Category Cosmetic Category Cosmetic Ingredients 1100 ppm NaF Use/Claim Thermal spring water mouth spray for Ingredients Camphor, Eucalyptus, Menthol Ingredients 250 ppm Fluor Use/Claim Thermal spring water dental whitening tooth sensible gums, dry mouth, bad breath Use/Claim Pharma quality non greasy decongestive Use/Claim Prevention of tooth decay in temporary teeth. paste / 1100 ppm NaF Main Indication Dental Hygiene menthol chest rub, paraben free The stabilized alkaline pH of the Thermal Main Indication Dental Hygiene Main Indication Cough & Cold spring water neutralises acids and reinforces Unit Size 200 ml metallic flask, 2 application devices Unit Size 75 ml Polyethylene tube HDPE Unit Size 50 ml, Flip Top or normal Polyethylene tube, the brushing action for an improved efficiency Status Available against tooth decay. Mango flavour. Status Available diam. 35 mm HDPE Sold In (Countries) T.B. D Status Available Main Indication Dental Hygiene Sold In (Countries) T.B. D Sold In (Countries) T.B. D Unit Size 50 ml Polyethylene tube HDPE Status Available Sold In (Countries) T.B.D.
  6. 6. OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY NAME Abc Farma Internacional is chiefly engaged in the development and design of new ABC Farma technologies for application in the cosmetics and pharmaceutical industry. Specialised in the manufacturing and distribution of the transdermal and topical patches, Fast-Edible CITY medical films, mechanical action strips, impregnated masks, Wet wipes, technological Barcelona fabrics loaded with medical or cosmetic ingredients as well as Hyaluronic acid products. COUNTRY Contact Preson: Anna Guimerá (aguimera@abcfarma.com) Spain Contact Telephone Number: 0034 93487 9670 / 00 601 18 65 11 mobile PACK SHOTS ~ Approved & In-development ~ THE INDUSTRY’S FIRST PRINTED DIRECTORY OF PRODUCTS AVAILABLE FOR LICENSING 7000 PRODUCTS • Delivered to sales, marketing & in-licensing teams worldwide OTC PRODUCTS Product name Category Capillari HAIR LOSS PATCH Cosmetic Product name Category FÒRFORA PLUS Cosmetic Ingredients Adenosine, Cysteine, Ruscus, Bamboo, Serenoa Ingredients Copaifera Officinalis, Brasil Nut, Vitamin E, • Detailed product information (generic name, form, strength...) Serrulata, Vitis Vinifera Vitamin B, L-Cysteine Use/Claim • Extra dossier information (dossier format/status, regulatory status...) The main objective it is to fight hair loss. Its Use/Claim It is a novel product with action Anti-dandruff components have a direct impact on the formation for exclusive use by the dermatologist. EDITION 2 NOW OUT, EDITION 3 OUT MARCH 2011 of hair and blood circulation at the scalp, thus Main Indication Dermatitis seborrhea avoiding so the weakest hairs fall down Unit Size 2 sachets (56 p.), 2 months treatment Email NOW to purchase a copy and advertising rates Main Indication To prevent hair loss Status Full develop Unit Size 2 sachet (56 p.), 2 months treatment Sold In (Countries) In various EU, Russia Email: directory@genericlicensing.com or Phone: +44 870 752 4105 Status Full develop Sold In (Countries) In various EU, Russia DIRECTORY.GENERICLICENSING.COM
  7. 7. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name ABBRONZANTE QUICK SUN PATCH Product name LEGPATCH Tired Legs Product name QUELOPATCH Product name CICADIL Category Cosmetic Category Cosmetic Category Cosmetic Category CE mark IIB Ingredients μeta-carontene, Tyrosine, Lutein, Lycopne, Ingredients Ruscus aculeatus, Centella Asiatica, Horse Ingredients Laluzero. Special Hyaluronic acid having a Ingredients Laluzero. Special Hyaluronic acid having a Vitamin E Chestnut, Vaccinium Myrtillus molecular weight lower than 50 KDa and solution molecular weight lower than 50 KDa and Use/Claim To enhance the natural defences of skin against Use/Claim It has a firming action, strengthen and viscosity close to zero. solution viscosity close to zero. the sun and mitigate the effects of aging Refreshing of the skin of the legs Use/Claim Quelopatch Scar Reducer is specially designed Use/Claim Lesions: Barrier function sterile gauzes Main Indication Patch for a more efficient and safer exposition to Main Indication Fatigued legs: Patch that relieves swelling to help the scar to regain its function and preventing additional infection and improving UV rays and heaviness appearance go back to being normal skin. the healing process Unit Size 4 sachets (56 p.), 2 months treatment Unit Size 01 sachet 28 patches, 01 month treatment Main Indication Scars treatment Main Indication Sterile Gauze for breached skin Status Full develop Status Full develop Unit Size 1 sachet (2 p.) Unit Size Consumer unit of 20 sterile gauze in a twin Sold In (Countries) Iberia, Italy, Fr, Mx Sold In (Countries) Iberia, Italy, France Status Full develop sachet Sold In (Countries) Spain, Italy Status Full develop Sold In (Countries) Spain, Italy Product name IALUPATCH Product name PSORIPATCH Product name IALURAPID ZERO Vaginal Douche Product name IALURAPID ZERO Gel Category CE mark class 1 Category Cosmetic Category CE mark class 2a Category CE mark class 2a Ingredients Laluzero. Special Hyaluronic acid having a Ingredients UREA, ALOE VERA, IALUZERO® Ingredients Laluzero. Special Hyaluronic acid having a Ingredients Laluzero. Special Hyaluronic acid having a molecular weight lower than 50 KDa and solution (Hyaluronic Acid), Mangnesio Ascrobil fosfato molecular weight lower than 50 KDa and solution molecular weight lower than 50 KDa and viscosity close to zero. Use/Claim It is a patch of Hydro gel to treat the plaques viscosity close to zero. solution viscosity close to zero. Use/Claim Specially designed to help the skin to regain its of psoriasis and the scales Use/Claim Intimate cleansing: first aid solution for vaginal Use/Claim Provides hydration protection and hygiene functionality and appearance following the Main Indication Dry and scaling skin irritation and small lesions mucosa damaged or injured formation of a scar. Thanks to H.A. helps reduces 1 sachet (3 p.) Main Indication Intimate cleansing Main Indication Daily vaginal moisturizing gel Unit Size the time of the physiological healing process. Unit Size 3 uds. (30 ml.) Unit Size 1 unit (50ml) Status Full develop Main Indication Stretch mark Status Full develop Status Full develop Sold In (Countries) Spain, Italy Unit Size 1 sachet (2 p.) Sold In (Countries) Spain, Italy Sold In (Countries) Spain, Italy Status Full develop Sold In (Countries) Spain, Italy
  8. 8. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name ABBRONZANTE QUICK SUN PATCH Product name LEGPATCH Tired Legs Product name QUELOPATCH Product name CICADIL Category Cosmetic Category Cosmetic Category Cosmetic Category CE mark IIB Ingredients μeta-carontene, Tyrosine, Lutein, Lycopne, Ingredients Ruscus aculeatus, Centella Asiatica, Horse Ingredients Laluzero. Special Hyaluronic acid having a Ingredients Laluzero. Special Hyaluronic acid having a Vitamin E Chestnut, Vaccinium Myrtillus molecular weight lower than 50 KDa and solution molecular weight lower than 50 KDa and Use/Claim To enhance the natural defences of skin against Use/Claim It has a firming action, strengthen and viscosity close to zero. solution viscosity close to zero. the sun and mitigate the effects of aging Refreshing of the skin of the legs Use/Claim Quelopatch Scar Reducer is specially designed Use/Claim Lesions: Barrier function sterile gauzes Main Indication Patch for a more efficient and safer exposition to Main Indication Fatigued legs: Patch that relieves swelling to help the scar to regain its function and preventing additional infection and improving UV rays and heaviness appearance go back to being normal skin. the healing process Unit Size 4 sachets (56 p.), 2 months treatment Unit Size 01 sachet 28 patches, 01 month treatment Main Indication Scars treatment Main Indication Sterile Gauze for breached skin Status Full develop Status Full develop Unit Size 1 sachet (2 p.) Unit Size Consumer unit of 20 sterile gauze in a twin Sold In (Countries) Iberia, Italy, Fr, Mx Sold In (Countries) Iberia, Italy, France Status Full develop sachet Sold In (Countries) Spain, Italy Status Full develop Sold In (Countries) Spain, Italy Product name IALUPATCH Product name PSORIPATCH Product name IALURAPID ZERO Vaginal Douche Product name IALURAPID ZERO Gel Category CE mark class 1 Category Cosmetic Category CE mark class 2a Category CE mark class 2a Ingredients Laluzero. Special Hyaluronic acid having a Ingredients UREA, ALOE VERA, IALUZERO® Ingredients Laluzero. Special Hyaluronic acid having a Ingredients Laluzero. Special Hyaluronic acid having a molecular weight lower than 50 KDa and solution (Hyaluronic Acid), Mangnesio Ascrobil fosfato molecular weight lower than 50 KDa and solution molecular weight lower than 50 KDa and viscosity close to zero. Use/Claim It is a patch of Hydro gel to treat the plaques viscosity close to zero. solution viscosity close to zero. Use/Claim Specially designed to help the skin to regain its of psoriasis and the scales Use/Claim Intimate cleansing: first aid solution for vaginal Use/Claim Provides hydration protection and hygiene functionality and appearance following the Main Indication Dry and scaling skin irritation and small lesions mucosa damaged or injured formation of a scar. Thanks to H.A. helps reduces 1 sachet (3 p.) Main Indication Intimate cleansing Main Indication Daily vaginal moisturizing gel Unit Size the time of the physiological healing process. Unit Size 3 uds. (30 ml.) Unit Size 1 unit (50ml) Status Full develop Main Indication Stretch mark Status Full develop Status Full develop Sold In (Countries) Spain, Italy Unit Size 1 sachet (2 p.) Sold In (Countries) Spain, Italy Sold In (Countries) Spain, Italy Status Full develop Sold In (Countries) Spain, Italy
  9. 9. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY NAME We are a flexible and innovative team, open to new ideas for future developments. Biogened We have high quality marketing and regulatory affairs management as well as a comprehensive sales network, enabling us to bring new ideas to market efficiently. Product name Protection of the Buccal Mucosa Product name VRR CITY Our production is compliant with GMP standards. Biogened as generic company is Category CE mark class 2a Category CE mark class 2a Lodz interested in buying licenses from CNS, oncology, Dermatology, Respiratory system, OTC - Cold. Ingredients Laluzero. Special Hyaluronic acid having a Ingredients Mechanical barrier, perfect occlusion of the COUNTRY Contact Preson: Karolina Lichanska (karolina.lichanska@biogened.pl) molecular weight lower than 50 KDa and solution zone affected by the wart. Poland Contact Telephone Number: 48 42 651 31 52 viscosity close to zero. Use/Claim Warts: Healing protection patch for barrier Use/Claim Palate and gums: mouthwash, gum gel, active effect and infection prevention PACK SHOTS sprays for irritation problems and small lesion in Main Indication Wart Patch, Topical application gums and palate Unit Size 4 sachets (48 patches) Main Indication To preserve the integrity of the oral mucous Status Full develop membrane Sold In (Countries) Spain, Italy Unit Size Fluid 250ml, Gel Tube 20ml Status Full develop Sold In (Countries) Spain, Italy OTC PRODUCTS Product name "Dermedic" dermocosmetics Product name "Ellexir" dermocosmetics Product name VNO PIKAN No mosquitoes patch Category OTC Category OTC Category General sale Ingredients Many active substances, without colorants, flavors, Ingredients Active substances: hialuronic acid, peptides ( Ingredients Citronella essential oils irritants, parabens a unique composition of technologically Use/Claim Self-adhesive strips saturated with resin- advanced active substances) Use/Claim Comprehensive taking care of the skin, stimulate embedded microcapsules on the outer patch its regeneration, increase resistance, delay aging Use/Claim Very exclusive series of dermocosmetics surface that gradually release the aromatic processes, reduction skin defects created for immediate delay of appearing the charge of their essential oils over time. Main Indication Problematic skin wrinkles Main Indication To keep mosquito’s away Unit Size 15g, 50g, 150g, 200g Main Indication Mimic wrinkles and physiological wrinkles Unit Size 01 consumer unit with 48 patches Status Available Unit Size 50g Status Full develop Sold In (Countries) Arabian countries, Nordic Countries, Slovakia Status Available Sold In (Countries) Launched in various EU markets Sold In (Countries) Portugal, Arabian countries, Nordic Countries, Czech Republic, U.S
  10. 10. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY NAME Bioxtract develops evidence based, natural food supplements, in unique and BioXtract proprietary formulations, offering improved bio availability and efficacy. We work business to business, offering finished products in bulk, ready for commercialisation by Product name “ProLady" supplements Product name "Rutimal" supplements CITY marketing partners worldwide. Category OTC Category OTC Louvain-la-Neuve Ingredients Red clover, Salvia, Melissa, Guarana, Yerba Ingredients Vitamins, Sage, Minerals, Rutoside, Garil, COUNTRY Contact Preson: Camilla Mackenzie (camilla.mackenzie@bioxtract.com) Mate, Acai, Aloe, Vitamins, Spiruline, Selenium Honey, lemon ,grapefruit juice Belgium Contact Telephone Number: +32-10-222870 Use/Claim etc. Use/Claim Lollypops for children and capsules for adults Main Indication For taking care of woman's health in states of decreased immunity PACK SHOTS Typical woman's problems Main Indication Sore throat, decreased immunity, loss of Unit Size 30 and 90 appetite," journey" problems Status Available Unit Size 10, 30 , 120 pack of lollypops and 30/90 Sold In (Countries) Arabian countries, Nordic Countries, Portugal capsules Status Available Sold In (Countries) Arabian countries, Nordic Countries, Portugal, Balkans OTC PRODUCTS Product name Arantal Product name Nasaler Category Food supplement Category Food supplement Ingredients Curcumin Ingredients Curcumin + quercetin Use/Claim A new formulation of highly bioavailable curcumin, Use/Claim A new formulation of highly bioavailable with efficacy on pain and inflammation curcumin, combined with quercetin to treat Main Indication Osteoarthritis symptoms of allergic rhinitis, having anthi- Soft gelatin capsules, supplied in bulk histamine and anti-inflammatory properties. Form EU Food supplement, TGA listing (Australia) Main Indication Allergic rhinitis Status Sold In (Countries) EU Form Soft gelatin capsules, supplied in bulk Status EU Food supplement, TGA listing (Australia) Sold In (Countries) EU
  11. 11. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement COMPANY PROFILE COMPANY NAME Diapharm is a full-service provider for the healthcare industry. With about 100 Diapharm UK employees, Diapharm supports pharmaceutical companies in all questions concerning regulatory affairs, medical & clinical development, quality management and business Product name Cognityl Product name Regulid CITY development. Its activities focus on the sectors of medicinal products, food Category Food supplement Category Food supplement London / Munster supplements and dietetic food, medical devices and cosmetics. Diapharm is at the service of multinational companies as well as start-ups and mid-sized businesses. Ingredients Theobromine + caffeine Ingredients Vinyldithiins + sulfides COUNTRY Contact Preson: Karim Sultan (karim.sultan@diapharm.com) Use/Claim A product based on cocoa and tea extracts, with Use/Claim An innovative formulation of high Contact Telephone Number: +44 203 178 2790 UK / Germany Main Indication proven effect on focus, attention and mental performance garlic active principals, with a energy Mental alertness combined activity on cholesterol parameters PACK SHOTS Form Tablets, supplied in bulk involved in metabolic syndrome. Status EU Food supplement, TGA listing (Australia), Main Indication Metabolic syndrome Malaysian health supplement registration Form Liquid filled hard gelatin capsules, supplied in Sold In (Countries) EU, SE Asia bulk Status EU Food supplement, TGA listing (Australia), Malaysian health supplement registration Sold In (Countries) EU, SE Asia OTC PRODUCTS Product name Medicinal product (homeopathic) Product name Medicinal product (homeopathic) Category Medicinal product (homeopathic) Category Medicinal product (homeopathic) Ingredients Aesculus hippocastanum Dil D1, Arnica montana, Ingredients Drosera Dil. D4, Cephalis Ipecacuanha Dil. Silybum marianum Dil. D1, Hamamelis virginiana D6, Rumex crispus Dil. D4, Eriodictyon Dil. D1, Lachesis mutus Dil. D6, Lycopedium californicum Dil. D4, Echinacea clavatum Dil. D4, Melilotus officinalis Dil. D3 Use/Claim Cough and cold Varicosis Main Indication Homoeopathic medicinal product for intake Use/Claim Homoeopathic medicinal product for intake against against infects of the upper respiratory tract Main Indication varicose veins /varices Unit Size Mixture in amber bottle, 50 ml Mixture in amber bottle, 50 ml Status Marketing authorization Unit Size Marketing authorization Sold In (Countries) DE Status DE Sold In (Countries)
  12. 12. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Ingredients Artichoke leaf 400 mg Ingredients Artichoke leaf 400 mg Ingredients Chaste tree fruit 4 mg Ingredients Chaste tree fruit 4 mg Use/Claim Digestion & liver Use/Claim Digestion & liver Use/Claim Climacteric symptoms, menstrual disturbances Use/Claim Climacteric symptoms, menstrual disturbances Main Indication For dyspeptic complaints. Stimulates healthy bile Main Indication For dyspeptic complaints. Stimulates healthy Main Indication Well-established use: Irregularities of the Main Indication Well-established use: Irregularities of the production. This helps improve blood lipid levels. bile production. This helps improve blood lipid menstrual cycle, menstrual disturbances; tension menstrual cycle, menstrual disturbances; Unit Size Capsule levels. and swelling of the breasts (mastodynia); tension and swelling of the breasts Status Marketing authorization Unit Size Capsule premenstrual syndrome. - Traditional Use: (mastodynia); premenstrual syndrome. - Status Dossier Traditional herbal medicinal product used to help Traditional Use: Traditional herbal medicinal Sold In (Countries) UK relieve symptoms associated with premenstrual product used to help relieve symptoms Sold In (Countries) All European countries syndrome associated with premenstrual syndrome Unit Size Film-coated tablet Unit Size Film-coated tablet Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Status Marketing authorization Dossier Status Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Sold In (Countries) UK Sold In (Countries) All European countries Ingredients Black cohosh rhizome 6.5 mg Ingredients Black cohosh rhizome 6.5 mg Product name Medical Device Product name Medicinal product (WEU/THMP) Use/Claim Climacteric symptoms, menstrual disturbances Use/Claim Climacteric symptoms, menstrual disturbances Category Medical device Category Medicinal product (WEU/THMP) Main Indication Well-established use: For improvement of climacteric (menopausal) symptoms and Main Indication Well-established use: For improvement of Ingredients Chitosan 500 mg Ingredients Devil´s claw root 600 mg dysmenorrhoeic neurovegetative disorders. - climacteric (menopausal) symptoms and Use/Claim Treatment of elevated blood lipid levels (Weight Use/Claim Aches Traditional Use: Traditional herbal medicinal dysmenorrhoeic neurovegetative disorders. - control) Main Indication Traditional Use: Traditional herbal medicinal product used to relieve the symptoms of the Traditional Use: Traditional herbal medicinal Main Indication Binding of nutritional fat in order to support the product used for the relief of backache, menopause, such as hot flushes, night sweats product used to relieve the symptoms of the treatment of overweight people on a fat reduced rheumatic or muscular pain, and general and temporary changes in mood. menopause, such as hot flushes, night diet, maintenance of bodyweight within a fat aches and pain in the muscles and joints - Unit Size Film-coated tablet sweats and temporary changes in mood. conscious diet, reduction of cholesterol intake HMPC monograph: Traditional HMP for relief Marketing authorization Unit Size Film-coated tablet Unit Size Tablet of minor articular pain Status Sold In (Countries) UK Status Dossier Status CE mark Unit Size Film-coated tablet Sold In (Countries) All European countries Sold In (Countries) All European countries Status Marketing authorization Sold In (Countries) UK
  13. 13. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Ingredients Devil´s claw root 600 mg Ingredients Feverfew herb 100 mg Ingredients Hawthorn leaf and flower 450 mg Ingredients Hawthorn leaf and flower 300 mg Use/Claim Aches Use/Claim Aches and migraine Use/Claim Mild cardiac insufficiency Use/Claim Mild cardiac insufficiency Main Indication Traditional Use: Traditional herbal medicinal Main Indication Traditional herbal medicinal product used for Main Indication Mild cardiac insufficiency, senile heart. Main Indication Mild cardiac insufficiency, senile heart. product used for the relief of backache, the prevention of migraine headaches, based Unit Size Film-coated tablet Unit Size Coated tablet rheumatic or muscular pain, and general aches on traditional use only Status Dossier Status Marketing authorization and pain in the muscles and joints - HMPC Unit Size Capsule Sold In (Countries) All European countries Sold In (Countries) DE monograph: Traditional HMP for relief of minor Status Marketing authorization articular pain Sold In (Countries) UK Unit Size Film-coated tablet Status Dossier Sold In (Countries) All European countries Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Ingredients Devil´s claw root 600 mg Ingredients Feverfew herb 100 mg Ingredients Hawthorn leaf and flower 300 mg Ingredients Hawthorn leaf and flower 40 mg, Potassium Use/Claim Aches Use/Claim Aches and migraine Use/Claim Mild cardiac insufficiency aspartat 150 mg, Magnesium aspartat 150 mg Main Indication Traditional Use: Traditional herbal medicinal Main Indication Traditional herbal medicinal product used for Main Indication Mild cardiac insufficiency, senile heart. Use/Claim Mild cardiac insufficiency product used for the relief of backache, rheumatic the prevention of migraine headaches, based Unit Size Coated tablet Main Indication A traditional herbal medicinal product used for or muscular pain, and general aches and pain in on traditional use only Status Dossier the relief of mild cardiac injuries (senile heart), the muscles and joints - HMPC monograph: Unit Size Capsule based on traditional use only Sold In (Countries) All European countries Traditional HMP for relief of minor articular pain Status Dossier Unit Size Coated tablet Unit Size Film-coated tablet Sold In (Countries) All European Countries Status Dossier Status Dossier Sold In (Countries) All European countries Sold In (Countries) All European countries
  14. 14. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name Medical device Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medical device Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Ingredients Lactobacillus-johnsonii EU1 4x10^5 - 4x10^7 Ingredients Milk Thistle fruit 177.4 - 240.4 mg, corresp. to Ingredients Passionflower herb 250 mg, Valerian root 125 mg Ingredients Passionflower herb 250 mg, CFU/cap. 108.2 mg Silymarin Use/Claim Mild nervous tension, sleep disorder Valerian root 125 mg Use/Claim Treatment of gastro-intestinal disorders Use/Claim Digestion & liver Main Indication Well-established Use: For the relief of mild Use/Claim Mild nervous tension, sleep disorder Main Indication Treatment and prophylaxis of non-specific Main Indication Supportive treatment of chronic-inflammable nervous tension and difficulty in falling asleep. - Main Indication Well-established Use: For the relief of mild diarrhea,Treatment and prevention of liver injuries, cirrhosis of the liver and toxic Traditional Use: Traditional herbal medicinal nervous tension and difficulty in falling recurrences of antibiotic-induced diarrhea liver injuries (caused by hepatotoxic agents) product used for the temporary relief of sleep asleep. - Traditional Use: Traditional herbal Unit Size Opaque hard capsule, size 1 Unit Size Capsule disturbances due to symptoms of mild anxiety. medicinal product used for the temporary Status CE mark Status Dossier Unit Size Coated tablet relief of sleep disturbances due to symptoms Status Marketing authorisation of mild anxiety. Sold In (Countries) All European countries Sold In (Countries) All European countries Sold In (Countries) UK, PL Unit Size Coated tablet Status Dossier Sold In (Countries) All European countries Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Ingredients Nettle root 460 mg Ingredients Passionflower herb 425 mg Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Use/Claim Prostate Use/Claim Mild nervous tension, sleep disorder Ingredients Pelargonium root 20 mg Ingredients Plantain herb 300 mg Main Indication Traditional herbal medicinal product used to Main Indication Well-established Use: For the relief of mild Use/Claim Cough and cold Use/Claim Cough and cold relieve urinary discomfort in men with an nervous tension. - Traditional Use: Traditional Main Indication Traditional herbal medicinal product for the relief Main Indication Catarrh of the respiratory tract, inflammations enlarged prostate (BPH). herbal medicinal product for relief of mild of symptoms of upper respiratory tract infections of the oral and pharyngeal mucosa. Unit Size Film-coated tablet symptoms of mental stress and to aid sleep. including common cold, such as sore throat, Unit Size Effervescent tablet Dossier Unit Size Coated tablet cough and blocked or runny nose. Status Marketing authorization Status Sold In (Countries) All European countries Status Dossier Unit Size Film-coated tablet Sold In (Countries) DE Sold In (Countries) All European countries Status Dossier Sold In (Countries) All European countries
  15. 15. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Ingredients Plantain herb 300 mg Ingredients Red vine leaf 180 mg Ingredients St. John´s Wort herb 250 mg Ingredients St. John´s Wort herb 425 mg Use/Claim Cough and cold Use/Claim Circulatory function Use/Claim Low mood Use/Claim Low mood Main Indication Catarrh of the respiratory tract, inflammations of Main Indication Symptomatic relief of venous relief to help Main Indication Well-established use: Psychovegetative Main Indication Well-established use: Psychovegetative the oral and pharyngeal mucosa. maintain healthy leg vein circulation. disorders, mild depressive moods. - Traditional disorders, mild depressive moods. - Unit Size Effervescent tablet Unit Size Capsule Use: Traditional herbal medicinal product used to Traditional Use: Traditional herbal medicinal Status Dossier Status Dossier relieve the symptoms of slightly low mood and product used to relieve the symptoms of Sold In (Countries) All European countries mild anxiety. slightly low mood and mild anxiety. Sold In (Countries) All European countries Unit Size Film-coated tablet Unit Size Coated tablet Status Dossier Status Dossier Sold In (Countries) All European countries Sold In (Countries) All European countries Product name Medicinal product (WEU/THMP) Product name Medical Device Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medical device Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Ingredients Siberian ginseng root 120 mg Ingredients Simethicon 125mg Ingredients St. John´s Wort herb 300 mg, Black cohosh Ingredients St. John´s Wort herb 120 mg, Use/Claim rhizome 6.4 mg Valerian root 56 mg Use/Claim Convalescence Use/Claim Treatment of gastro-intestinal disorders Main Indication Climacteric symptoms, menstrual disturbances Use/Claim Low mood Main Indication Traditional herbal medicinal product for symptoms Main Indication De-foaming agent for the symptomatic of asthenia such as fatigue and weakness, treatment of flatulence and gastrointestinal Traditional herbal medicinal product for the relief Main Indication Traditional herbal medicinal product for the exclusively based upon long-standing use complaints, e.g. Meteorism of neurovegetative disorders and low mood in relief of slightly low mood and mild anxiety, connection with menopausal symptoms, sleep disturbances due to symptoms of mild Unit Size Capsule Unit Size Chewable Soft Gelatin Capsule exclusively based upon long-standing use. anxiety, exclusively based upon long-standing Status Dossier Status CE mark use. Unit Size Coated tablet Sold In (Countries) All European countries Sold In (Countries) All European countries (except UK, IRE) Status Dossier Unit Size Coated tablet Sold In (Countries) All European countries Status Dossier Sold In (Countries) All European countries
  16. 16. OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement Product name Medicinal product (WEU/THMP)Medicinal Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Ingredients Valerian root 150 mg Ingredients Valerian root 150 mg Ingredients Valerian root 450 mg Ingredients Valerian root 425 mg, Melissa leaf 220 mg Use/Claim Mild nervous tension, sleep disorder Use/Claim Mild nervous tension, sleep disorder Use/Claim Mild nervous tension, sleep disorder Use/Claim Mild nervous tension, sleep disorder Main Indication Herbal medicinal product for the relief of mild Main Indication Herbal medicinal product for the relief of mild Main Indication Well-established Use: Herbal medicinal product Main Indication For the relief of mild nervous tension and nervous tension and sleep disorders. (also for nervous tension and sleep disorders. (Also for the relief of mild nervous tension and sleep difficulty in falling asleep. children over 6 years old) for children over 6 years old) disorders. Unit Size Coated tablet Unit Size Coated tablet Unit Size Coated tablet Unit Size Coated tablet Status Marketing authorization Status Marketing authorization Status Dossier Status Dossier Sold In (Countries) DE Sold In (Countries) DE, UK, PL, PT Sold In (Countries) All European countries Sold In (Countries) All European countries Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Product name Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Category Medicinal product (WEU/THMP) Ingredients Valerian root 300 mg Ingredients Valerian root 300 mg Ingredients Valerian root 425 mg, Melissa leaf 220 mg Ingredients Valerian root 125 mg, Melissa leaf 112.5 mg, Use/Claim Mild nervous tension, sleep disorder Passionflower herb Use/Claim Mild nervous tension, sleep disorder Use/Claim Mild nervous tension, sleep disorder Main Indication For the relief of mild nervous tension and Use/Claim Mild nervous tension, sleep disorder Main Indication Herbal medicinal product for the relief of mild Main Indication Herbal medicinal product for the relief of mild nervous tension and sleep disorders. (Also for nervous tension and sleep disorders. (Also difficulty in falling asleep. Main Indication For the relief of mild nervous tension and children over 6 years old) for children over 6 years old) Unit Size Coated tablet difficulty in falling asleep. Unit Size Coated tablet Unit Size Coated tablet Status Dossier Unit Size Coated tablet Status Marketing authorization Status Dossier Sold In (Countries) All European countries Status Marketing authorization Sold In (Countries) DE Sold In (Countries) All European countries Sold In (Countries) UK, AT

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