Brazil

Communication of Temporary Interruption of Commercialization Tykiticip (Gefitinib)

Cipla Brasil informs that it has recently voluntarily recalled batch GJ30337 of product TYKITICIP (gefitinib) as part of its ongoing commitment to the quality of its products and the health and safety of its patients.

In view of this situation, and due to logistical issues related to the anticipation of the manufacturing and import of new batches, we regret to inform that, since 22/08/2024, the commercialization of the product TYKITICIP has been temporarily interrupted in the Brazilian market.

The normalization of the commercialization of the product TYKITICIP is estimated for March 2025. We recognize the impact that this interruption may have on ongoing treatments and current commercial agreements. Therefore, we will keep all our patients, customers and partners informed of any relevant updates throughout this process.

If you have any questions or require additional information, please contact the Customer Service Center (SAC) by calling 0800 725 0444 or by email at farmacovigilancia.br@cipla.com.

Communication of Voluntary Recall – Tykiticip Batch GJ30337

Cipla Brasil Imp. and Dist. de Medicamentos Ltda., a legal entity governed by private law, registered under CNPJ 18.268.051/0001-64, informs that the batch GJ30337 of the medicine Tykiticip (Gefitinib) 250 mg with 30 tablets, Registration Nº 1.1541.0014.001-8, manufactured on 05/2023 and expiry date 04/2025, will have the market volunteer recall in accordance with RDC Nº 658/2022 and RDC Nº 625/2022 from ANVISA.

We inform you that the voluntary recall, risk class III refers to non-compliance with one of the control parameters in the stability study detected in the period of 12 months after the date of manufacture of the product, and there is no risk in relation to the use or exposure of the drug that may cause a risk to health in compliance with all quality criteria.

For more information regarding the recall, please, refer to letters below:

• Notification Of Voluntary Drug Recall To Healthcare Professionals - GJ30337 - Tykiticip 250mg
• Notification Of Voluntary Drug Recall To Patients - GJ30337 - Tykiticip 250mg (Annexure I)