Guideline: CPMP/QWP/609/96 Rev 1 Note for guidance on Declaration of Storage Conditions for Medicinal Products Particulars and Active Substances (Annex to note for Guidance on Stability Testing of New Active Substances and Medicinal Products, Annex to Note for Guidance on Stability of Existing Active Substances and Related Finished Products) (Date of coming into operation October 2003), Rev 2 withdrawn
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| Titel: | CPMP/QWP/609/96 Rev 1 Note for guidance on Declaration of Storage Conditions for Medicinal Products Particulars and Active Substances (Annex to note for Guidance on Stability Testing of New Active Substances and Medicinal Products, Annex to Note for Guidance on Stability of Existing Active Substances and Related Finished Products) (Date of coming into operation October 2003), Rev 2 withdrawn |
| Kurztitel: | CPMP/QWP/609/96/Rev 1 |
| Internet: | http://www.ema.europa.eu/pdfs/human/qwp/060996en.pdf |
| Herkunft/Verlag: | www.ema.europa.eu |
| Inhalt: | Diese von der EMEA herausgegebene CPMP-Leitlinie behandelt die Laufzeit-Deklaration von Fertigarzneimitteln. Je nach Ergebnis der Stabilitätsprüfung sind unterschiedliche Angaben auf dem Etikett notwendig (z.B. """"nicht über 30 Grad Celsius lagern""""). Diese Anforderungen gelten in gleicher Weise auch für Wirkstoffe. |
| Dokumentenart: | CPMP/QWP Approved Guideline |
