Direct healthcare professional communication on the similarity between names of medicinal products Caprelsa (vandetanib) and Caprez (amlodipine)
21.02.2017
Sanofi-aventis Croatia d.o.o., as the local representative of Genzyme Europe BV, the marketing authorisation holder for Caprelsa (vandetanib), AstraZeneca d.o.o., the local representative of AstraZeneca AB, the previous marketing authorisation holder for Caprelsa and Alkaloid d.o.o., the marketing authorisation holder for Caprez (amlodipine), in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), have informed healthcare professionals of the similarity between names of medicinal products Caprelsa and Caprez, in order to avoid the possible risk of medication error associated with the confusion between the two products.
Summary
- Caprelsa 100 mg and 300 mg film-coated tablets (vandetanib) will be placed on the market in the Republic of Croatia, and Caprez 5 mg tablets as well as Caprez 10 mg tablets (amlodipine) are already available on the Croatian market.
- In order to avoid the possible risk of medication error associated with the confusion between the two medicinal products due to the similarity between their names, the attention is drawn to the fact that Caprelsa and Caprez have different active substances and different indications. Furthermore, the indications differ in their frequency, and the prescribing of medicinal products will involve doctors of different specialties.
- The active substance of Caprelsa is vandetanib, anti-cancer medicine from the class of tyrosine kinase inhibitors . Caprelsa is indicated for treatment of aggressive and symptomatic medullary thyroid cancer in patients with inoperable locally advanced or metastatic illness. The medicine is dispensed in pharmacies, based on restricted prescription.
- The active substance of Caprez is amlodipine, an antihypertensive from the class of calcium-channel blockers. Caprez is indicated for treatment of hypertension, chronic stable angina pectoris as well as vasospastic (Prinzmetal) angina. The medicine is dispensed in pharmacies, based on renewable prescription.
Further information
By the decision of the European Commission on 8 September 2016, the transfer of marketing authorisation for Caprelsa from AstraZeneca AB to Genzyme Europe BV has been approved, by which the company Sanofi acquired all rights related to Caprelsa (Genzyme Europe BV is a part of Sanofi Group). The Commission decision implies that all activities related to the transfer should be completed until 15 March 2017 at the latest. In accordance with this, medicine batches released before 15 March 2017 can have markings of AstraZeneca on their packaging.
Here you may view the direct healthcare professional communication.
Healthcare professionals are reminded that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED. HALMED recommends patients to contact their doctor or pharmacist regarding any adverse reaction they notice.
