HEALTH ALERT FOR COUNTERFEIT MEDICINES DETECTED IN OTHER COUNTRIES: TAGRISSO AND NORDITROPIN (Ministry of Health 3 December 2020)
On counterfeit medicines recently, the Directorate of Regulation of Health Products has received several alerts on counterfeit medicines from the Network to Combat Substandard and Counterfeit Medical Products of the Pan American Health Organization. Some of these alerts are about products that are marketed in Costa Rica, which is why this communication is issued. The following table presents the general data of the alerts that are related to products registered in our country. It is important to mention that to date no such counterfeits have been detected in the national territory. However, surveillance and product control activities are maintained in the market for the timely detection of national cases.
In Costa Rica there is a current sanitary registration for the medicine Tagrisso 80 mg manufactured by Astra Zeneca AB of Sweden: M-SE-18-00027. Tagrisso 40 mg is also registered with the same manufacturer: M-SE-18-00026.
Description of the counterfeit product Tagrisso 80 mgtablet coated, box with 30 tablets (Osimertinib). FHCP lot with expiration date 03/21.Secondary packaging (folding box) presents marked physical differences with respect to the original product: dimensions, type of cardboard, printing technique, type of font, color, error with diacritic marking in Swedish language, and security seal.
Description of the counterfeit product: Norditropin (Somatropina) Lot 9F033A9 not recognized by Novo Nordisk as original. Photos not available. In Costa Rica there are 2 current health registrations for the drug Norditropin manufactured by Novo Nordisk A/S of Denmark: 4112-IB-6416 (Norditropin10mg/1.5mL) and 4112-IB-6417 (Norditropin5mg/1.5mL). It should be remembered that Article 107 of the General Health Law No. 5395 states "It is prohibited to import, manufacture, trade, distribute or supply in any way, manipulate, use, consume or possess for trade, deteriorated, adulterated or counterfeit medicines".