Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1791165
Name of medicinal product: MYRELEZ
Active substances:
Estonian, English, Latin
ATC code: H01CB03
Dosage form: solution for injection in pre-filled syringe
Route of administration: subcutaneous use
Strengh: 90mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: [Product name] is indicated for: * The treatment of individuals with acromegaly when the circulating levels of Growth Hormone (GH) and/or Insulin-like Growth Factor-1 (IGF-1) remain abnormal after surgery and/or radiotherapy, or in patients who otherwise require medical treatment. * The treatment of grade 1 and a subset of grade 2 (Ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumours (GEP-NETs) of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease (see section 5.1). * The treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumours.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated May 5, 2021)
Package information leaflet (PIL): EST  (last updated July 28, 2023)
Labelling:  (last updated May 5, 2021)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Amdipharm Limited 
Marketing authorization number: 1030221 
Marketing authorization issued on: May 5, 2021 
Marketing authorization expires on: May 5, 2026 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: April 11, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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