OTC & Biosimilar Directory 2010

OTC & Biosimilar
See our Global Generic Licensing Directory for over Directory Supplement
7000 DOSSIERS or visit
Edition 1, 2010

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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.

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.


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


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.

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
Status Available Main Indication Dental Hygiene
Sold In (Countries) T.B. D Unit Size 50 ml Polyethylene tube HDPE
Status Available

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


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
Unit Size 1 sachet (2 p.) Sold In (Countries) Spain, Italy Sold In (Countries) Spain, Italy
Status Full develop

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
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

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

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)


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


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
Unit Size Film-coated tablet
Status Dossier

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
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


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
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


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.
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


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)
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

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

OTC & Biosimilar Directory 2010

OTC & Biosimilar Directory 2010

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OTC & Biosimilar Directory 2010