YODAFAR Tablet Ref.[51122] Active ingredients: Potassium iodide

Source: Medicines Authority (MT)  Revision Year: 2019  Publisher: BIAL – Portela & Cª, S.AÀ Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal

Product name and form

YODAFAR 200 micrograms tablets.

YODAFAR 300 micrograms tablets.

Pharmaceutical Form

Yodafar 200 micrograms tablets: round, biconvex, white tablets scored on one side.

Yodafar 300 micrograms tablets: round, biconvex, white tablets.

Qualitative and quantitative composition

YODAFAR 200 micrograms tablets: each tablet contains 262 micrograms of potassium iodide, equivalent to 200 micrograms of iodine.

YODAFAR 300 micrograms tablets: each tablet contains 393 micrograms of potassium iodide, equivalent to 300 micrograms of iodine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Potassium iodide

Potassium iodide is indicated as a thyroid-blocking agent to prevent the uptake of radioactive iodine, for example after a nuclear accident or during a nuclear medicine investigation before administering a radioiodinated compound, which is metabolised to iodide or which contains radioiodine impurities.
List of Excipients

Sodium carboxymethyl starch (Type A)
Microcrystalline cellulose
Magnesium stearate
Mannitol

Pack sizes and marketing

YODAFAR 200 micrograms tablets: pack with 50 tablets in PVC-PVDC/Aluminium blister.

YODAFAR 300 micrograms tablets: pack with 50 tablets in PVC-PVDC/Aluminium blister.

Marketing authorization holder

BIAL – Portela & Cª, S.AÀ Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal

Marketing authorization dates and numbers

YODAFAR 200 micrograms tablets – MA004/00901
YODAFAR 300 micrograms tablets – MA004/00902

Date of first authorisation: 16th January, 2013
Date of renewal of the authorisation: 6th March 2017

Drugs

Drug Countries
YODAFAR Cyprus, Spain, Malta
 
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