The medicinal products Zypadhera 405 mg prolonged release suspension for injection (pulv. + solv.) vial 405 mg + 3 ml, Zypadhera 300 mg prolonged release suspension for IM injection (pulv. + solv.) vial 300 mg + 3 ml and Zypadhera 210 mg prolonged release suspension for IM injection (pulv. + solv.) vial 210 mg + 3 ml

Decision extending submission of the export of the medicinal products Zypadhera 405 mg prolonged release suspension for IM injection (pulv. + solv.) vial 405 mg + 3 ml, Zypadhera 300 mg prolonged release suspension for IM injection (pulv. + solv.) vial [...]

The draft extends an authorisation requirement for the export of a specific medicinal product intended for the Belgian market in the event of unavailability, under the conditions laid down in the Royal Decree of 19 January 2023 implementing Article 12f, subparagraph 2, of the Law of 25 March 1964 on medicinal products, Article 4(1), (2), first subparagraph, and (3), first subparagraph. Prior authorisation for a specific period (i.e. the duration of the notified planned unavailability period), namely until 31/03/2026.