Sinecatechins is an active pharmaceutical ingredient in the Antivirals group (D06BB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· revised April 22, 2026[1]
AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 3 WARNINGS AND PRECAUTIONS .................................................................................
3 ADVERSE REACTIONS................................................................................................... 5 DRUG INTERACTIONS ...................................................................................................
7 DOSAGE AND ADMINISTRATION ............................................................................... 7 OVERDOSAGE .................................................................................................................
7 ACTION AND CLINICAL PHARMACOLOGY ............................................................. 7 STORAGE AND STABILITY ........................................................................................... 8 DOSAGE FORMS, COMPOSITION AND PACKAGING ..............................................
[1]Health Canada (DPD) · 02411849 · revised April 22, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
8 PART II: SCIENTIFIC INFORMATION ................................................................................. 9 PHARMACEUTICAL INFORMATION........................................................................... 9 CLINICAL TRIALS .........................................................................................................
13 REFERENCES ................................................................................................................. 16 PART III: CONSUMER INFORMATION..............................................................................
17 VEREGEN® (sinecatechins) Ointment, 10% (w/w) Knight Therapeutics Inc.
Page 3 of 19 PrVEREGEN® Sinecatechins Ointment 10% w/w PART I:
HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients Topical (Sinecatechins) Ointment, 10% w/w Propylene glycol monopalmitostearate, Isopropyl myristate.
For a complete listing see Dosage Forms, Composition and Packaging section. INDICATIONS AND CLINICAL USE VEREGEN (sinecatechins) is indicated for the cutaneous treatment of external genital and perianal warts (condylomata acuminata) in immunocompetent patients aged 18 years and over.
Geriatrics (> 65 years of age):
The number of geriatric patients treated with VEREGEN was insufficient to determine whether they respond differently from younger subjects.
Pediatrics (< 18 years of age):
The safety and efficacy of VEREGEN in pediatric patients below the age of 18 years has not been established. CONTRAINDICATIONS VEREGEN (sinecatechins) is contraindicated in individuals with a history of sensitivity reactions to the extract from green tea leaves or to any of the components in the formulation or container.
For a complete listing see the Dosage Forms, Composition and Packaging section of the Product Monograph. WARNINGS AND PRECAUTIONS General VEREGEN (sinecatechins) should not be applied to open wounds, broken or inflamed skin. Treatment with VEREGEN is not recommended until the skin has completely healed from any previous surgical or drug treatment.
Avoid contact with the eyes, nostrils, lips and mouth. The use of an occlusive dressing should be avoided. VEREGEN is not for ophthalmic, oral, intravaginal, or intra-anal use. Do not expose the treated area to sunlight or UV irradiation, as VEREGEN has not been tested under these conditions.
VEREGEN® (sinecatechins) Ointment, 10% (w/w) Knight Therapeutics Inc. Page 4 of 19 The safety and effectiveness for treatment beyond 16 weeks or for multiple treatment courses have not been established. New warts may develop during treatment.
Safe sex methods (condoms) should be used until complete clearance of all warts as VEREGEN does not eliminate the HPV-virus and does not prevent transmission of the disease. VEREGEN may weaken condoms and vaginal diaphragms. Therefore, the ointment should be washed off the treated area before the use of condoms and sexual contact.
Additional methods of contraception should be considered. If the sexual partner of the patient is infected, treatment of the sexual partner is advisable to prevent reinfection. VEREGEN has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used for the treatment of these conditions.
Concomitant use of other local treatments in the wart area should be avoided Carcinogenesis and Mutagenesis See TOXICOLOGY, Carcinogenicity. Genitourinary Female patients with genital warts in the vulvar region should use the ointment with caution as treatment in this area is associated more often with severe local adverse reactions.
Accidental application into the vagina must be avoided. In case of accidental application into the vagina immediately wash off the ointment with warm water and mild soap. Uncircumcised male patients treating warts under the foreskin should retract the foreskin and clean the area daily to prevent phimosis.
g. ulceration, induration or increasing difficulty in retracting the foreskin). Immune Patients under immunosuppressive therapy should not use VEREGEN Ointment since the efficacy and safety in immunocompromised patients have not been established.
Local Inflammatory Reactions Mild local skin reactions such as erythema, pruritus, irritation (mostly burning), pain and oedema at the treatment site are frequent. Treatment may be continued only if the severity of the local skin reaction is acceptable.
These reactions should decrease after the first weeks of treatment. […]