Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®

Launched by NOVO NORDISK A/S · Jan 28, 2022

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
• • 2. The decision to initiate treatment with commercially available Sogroya® has been made by the patient/LAR and the treating physician before and independently from the decision to include the patient in this study.
• • 3. Male or female, no age limitation
• • 4. Diagnosis of AGHD (only severe case)
• • 5. GH treatment naïve ("naïve patients") or "switched patients". "Naïve patients" are patients who are not exposed to any GH product to date or patients who were exposed to other GH product more than 180 days prior to registration. "Switched patients" are patients who is now treated by other GH product or patients who were exposed to other GH product within 180 days prior to registration.
• Exclusion Criteria:
• • 1. Previous participation in this study. Participation is defined as having given informed consent in this study
• • 2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
• • 3. Patients with hypersensitivity to the active substance or to any of the excipients
• • 4. Patients with malignant tumor
• • 5. Female patients who are either pregnant or likely to be pregnant