ACTIKERALL

This brand name is authorized in the following countries: Austria Canada Estonia Spain Finland Lithuania Mexico Poland United Kingdom

Active ingredients

The drug ACTIKERALL contains a combination of these active pharmaceutical ingredients (APIs):

UNII U3P01618RT - FLUOROURACIL

Fluorouracil is an antineoplastic anti-metabolite. Anti-metabolites masquerade as purine or pyrimidine – which become the building blocks of DNA. They prevent these substances from becoming incorporated into DNA during the “S” phase (of the cell cycle), stopping normal development and division. Fluorouracil blocks an enzyme which converts the cytosine nucleotide into the deoxy derivative. In addition, DNA synthesis is further inhibited because Fluorouracil blocks the incorporation of the thymidine nucleotide into the DNA strand. Fluorouracil is used for the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Fluorouracil injection is indicated in the palliative management of some types of cancer, including colon, esophageal, gastric, rectum, breast, biliary tract, stomach, head and neck, cervical, pancreas, renal cell, and carcinoid.

Read about Fluorouracil
UNII O414PZ4LPZ - SALICYLIC ACID

Salicylic acid has bacteriostatic and fungicidal actions, but it is its keratolytic properties which are important for this medicinal product. When applied externally it produces slow and painless destruction of the epithelium.

Read about Salicylic acid

Medication package inserts

Below package inserts are available for further reading:

Title
Information Source
Document Type
 
Medicines & Healthcare Products Regulatory Agency (GB)
Summary of Product Characteristics (SPC)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code
Group title
Classification
Fluorouracil, combinations
L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01B Antimetabolites → L01BC Pyrimidine analogues
Discover more medicines within L01BC52

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country
Identification scheme
Identifier(s)
CA
Health Products and Food Branch
Identifier(s): 02428946
EE
Ravimiamet
Identifier(s): 1552014, 1848731
ES
Centro de información online de medicamentos de la AEMPS
Identifier(s): 77675
FI
Lääkealan turvallisuus- ja kehittämiskeskus
Identifier(s): 599927
GB
Medicines & Healthcare Products Regulatory Agency
Identifier(s): 191861
LT
Valstybinė vaistų kontrolės tarnyba
Identifier(s): 1064301
MX
Comisión Federal para la Protección contra Riesgos Sanitarios
Identifier(s): 233M2012
PL
Rejestru Produktów Leczniczych
Identifier(s): 100280775

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