Beslissing tot onderwerping van de uitvoer van de geneesmiddelen Zypadhera 405 mg inj.susp. verl. Afgifte (pdr. + oplosm.) i.m. flac. 405 mg + 3 ml, Zypadhera 300 mg inj.susp. verl. Afgifte (pdr. + oplosm.) i.m. flac. 300 mg + 3 ml en Zypadhera 210 mg inj.susp. verl. Afgifte (pdr. + oplosm.) i.m. flac. 210 mg + 3 ml bestemd voor de Belgische markt aan een voorafgaande toelating, de 8 février 2024
Artikel M.
BESLUIT de uitvoer van de geneesmiddelen Zypadhera 405 mg inj.susp. verl. Afgifte (pdr. + oplosm.) i.m. flac. 405 mg + 3 ml, Zypadhera 300 mg inj.susp. verl. Afgifte (pdr. + oplosm.) i.m. flac. 300 mg + 3 ml en Zypadhera 210 mg inj.susp. verl. Afgifte (pdr. + oplosm.) i.m. flac. 210 mg + 3 ml bestemd voor de Belgische markt aan een voorafgaande toelating te onderwerpen tot en met 31 december 2024.Deze beslissing treedt in werking op de dag van publicatie in het Belgisch Staatsblad.
Handtekening
De Minister van Volksgezondheid,
Brussel, 2 februari 2024.
F. VANDENBROUCKE
Aanhef
Gelet op de wet van 25 maart 1964 op de geneesmiddelen voor menselijk gebruik, artikel 12septies, tweede lid;
Gelet op het koninklijk besluit van 19 januari 2023 tot uitvoering van artikel 12septies, tweede lid, van de wet van 25 maart 1964 op de geneesmiddelen, artikel 4, § 1, § 2, eerste lid en § 3, eerste lid;
Overwegende dat de beperkte beschikbaarheid van de geneesmiddelen Zypadhera 405 mg inj.susp. verl. Afgifte (pdr. + oplosm.) i.m. flac. 405 mg + 3 ml, Zypadhera 300 mg inj.susp. verl. Afgifte (pdr. + oplosm.) i.m. flac. 300 mg + 3 ml en Zypadhera 210 mg inj.susp. verl. Afgifte (pdr. + oplosm.) i.m. flac. 210 mg + 3 ml aan het FAGG bekend werd gemaakt enerzijds door de firma via FarmaStatus en anderzijds door de groothandelaar-verdelers;
Overwegende dat de beschikbaarheid van van de geneesmiddelen Zypadhera 405 mg inj.susp. verl. Afgifte (pdr. + oplosm.) i.m. flac. 405 mg + 3 ml, Zypadhera 300 mg inj.susp. verl. Afgifte (pdr. + oplosm.) i.m. flac. 300 mg + 3 ml en Zypadhera 210 mg inj.susp. verl. Afgifte (pdr. + oplosm.) i.m. flac. 210 mg + 3 ml tot 31 december 2024...
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