Merck will continue to make available the old formula Levothirok for French patients who have a prescription "during 2019," said Valerie Leto, a pharmacist responsible for Merck France.
Less than 50,000 boxes will be available monthly, the volume corresponding to the "volumes available in 2018" and "patients' needs", said Ms. Leto, who insisted on the "transient" nature of this period "must enable patients to find a lasting alternative solution. "
The High Court in Toulouse on Monday limited the obligation to make available Levothirok (Euthirok) old formula for a period of 3 months from January 1, 2019 to 39 patients, but the laboratory confirmed on Tuesday AFP that all prescribing patients will be able to provide in 2019.
"The old formula will be available to all patients who have a prescription, and not just 39 patients who decide the Toulouse court," Leto told AFP.
The Laboratory claims to respond to a request by the National Drugs and Healthcare Product Safety Agency (ANSM), which listed five enduring solutions for patients with thyroid disorders at the end of October and confirmed that it assessed "other original specialties or generics" for "diversifying the therapeutic offer".
"As for Euthirok (equivalent to Levothirok's old formula), ANSM has asked Merck to continue its availability in France in 2019 to allow patients who continue to treat Euthirok in order to adapt to the new treatment, "the ANSM said in a statement released on October 31st.
ANSM recalled that Euthirok is available for limited duration and in limited quantities and that "levothyroxine-based medicines are preferred, which can be used regularly and perennial."
The old Levothirok formula is imported from Germany, since Merck does not have a French marketing authorization for Euthirok, but only import authorizations.
In Germany, the new formula will replace the old one in the first half of 2019, but Merck is committed to continuing to provide old formula to French patients in 2019 "from imports from other European countries," said Madame. summer.
In July, the European Medicines Agency issued a favorable opinion to launch a new Levothirok formula in 21 countries.
The Laboratory claims that it has not received any requests for the old formula to be available in countries in transition. Valerie Leto emphasized the existence of alternative "sustainable solutions" in the countries concerned, such as Switzerland.