Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1134560
Name of medicinal product: SOMATULINE AUTOGEL 120MG
Active substances:
Lanreotide
Estonian, English, Latin
ATC code: H01CB03
Dosage form: solution for injection in pre-filled syringe
Route of administration: subcutaneous use
Strengh: 120mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Somatuline Autogel 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 goal of treatment in acromegaly is to reduce GH and IGF-1 levels and where possible to normalise these values. 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 September 27, 2023)
Package information leaflet (PIL): EST  (last updated September 27, 2023)
Labelling:  (last updated November 22, 2023)
Last imported to Estonia: May 13, 2024
Marketing authorization holder: Ipsen Pharma 
Marketing authorization number: 442704 
Marketing authorization issued on: April 28, 2004 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  05.04.2024     Yes  C00-D48; E22.0-E22.0  Onkoloog, Endokrinoloog, Pediaater – endokrinoloog  No     neuroendokriinkasvaja või akromegaalia raviks 
100  05.04.2024     Yes  C00-D48; E22.0-E22.0  Onkoloog, Endokrinoloog, Pediaater – endokrinoloog  No  until 4 years  neuroendokriinkasvaja või akromegaalia raviks 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: April 25, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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