The FAMHP extends the prior authorization for the export of Zypadhera

The Federal Agency for Medicines and Health Products (FAMHP) is extending until March 31, 2027, the requirement for prior authorization for the export of the three dosages of the antipsychotic Zypadhera. The decision of September 29, 2026, signed by the Minister of Public Health Frank Vandenbroucke, was published in the Belgian Official Gazette on October 1, 2026, page 52626, under reference [C − 2026/007175].

The regime is based on Article 12septies, paragraph 2, of the Law of March 25, 1964, on medicinal products for human use, as amended by the Law of May 30, 2026, and on the Royal Decree of January 19, 2023, implementing this provision, in its Article 4, § 1, § 2, paragraph 1, and § 3, paragraph 1. The FAMHP has noted the unavailability of the medicines concerned, within the meaning of Article 2, 29), of the Royal Decree of December 14, 2006, relating to medicinal products for human use, and this unavailability is established until March 31, 2027.

The measure is not new: it renews a series of previous decisions.

• Decision of February 2, 2024: initial submission of export to prior authorization.
• Decision of November 24, 2024: first extension.
• Decision of June 16, 2025: second extension.
• Decision of December 3, 2025: third extension.
• Decision of March 3, 2026: fourth extension.
• Decision of September 29, 2026: fifth extension, until March 31, 2027, inclusive.

Three targeted presentations

The decision precisely lists the specialties whose export remains subject to prior authorization, all intended for the Belgian market:

• Zypadhera 405 mg prolonged-release susp. inj. (pwd. + solv.) i.m. vial 405 mg + 3 ml;
• Zypadhera 300 mg prolonged-release susp. inj. (pwd. + solv.) i.m. vial 300 mg + 3 ml;
• Zypadhera 210 mg prolonged-release susp. inj. (pwd. + solv.) i.m. vial 210 mg + 3 ml.

Maintenance treatment without an authorized alternative

Zypadhera is used for maintenance treatment in adult schizophrenic patients who have been sufficiently stabilized by oral olanzapine during the initial phase of treatment. The medication must be administered once every two or four weeks.

The FAMHP justifies the extension based on two findings: the lack of administration of the product will lead to the destabilization of schizophrenic patients who are unaware of their illness or whose treatment compliance is insufficient, and no other authorized medication is available for the maintenance treatment of these conditions. The conditions of Article 4, § 1, of the Royal Decree of January 19, 2023, are therefore met.

Entry into force and scope

The decision comes into effect on the day of its notification to wholesale distributors. It does not modify the regime applicable to other medicines: it is limited to the three presentations of Zypadhera mentioned and to the period running until March 31, 2027, inclusive.

For operators, the consequence is direct: any export of these three dosages outside of Belgium remains subject to prior authorization from the FAMHP, with no interruption of the regime since February 2024. For patients, the extension aims to preserve the availability of the maintenance treatment on the Belgian market, in the absence of any authorized alternative for this indication.

Official source: Belgian Official Gazette of October 1, 2026, page 52626, decision of September 29, 2026 of the Federal Agency for Medicines and Health Products, reference [C − 2026/007175].