Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1663859
Name of medicinal product: CLOZAPINE ACCORD
Active substances:
Clozapine
Estonian, English, Latin
ATC code: N05AH02
Dosage form: tablet
Route of administration: oral use
Strengh: 100mg
Amount in package: 50TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Treatment-resistant schizophrenia Clozapine is indicated in treatment-resistant schizophrenic patients and in schizophrenia patients who have severe, untreatable neurological adverse reactions to other antipsychotic agents, including atypical antipsychotics. Treatment resistance is defined as a lack of satisfactory clinical improvement despite the use of adequate doses of at least two different antipsychotic agents, including an atypical antipsychotic agent, prescribed for adequate duration. Psychosis during the course of Parkinson's disease Clozapine is also indicated in psychotic disorders occurring during the course of Parkinson's disease, in cases where standard treatment has failed.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated September 11, 2023)
Package information leaflet (PIL): EST  (last updated September 11, 2023)
Labelling:  (last updated September 11, 2023)
Last imported to Estonia: January 31, 2024
Marketing authorization holder: Accord Healthcare B.V. 
Marketing authorization number: 933617 
Marketing authorization issued on: March 7, 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  13.07.2024     Yes  F32.2-F32.3; F70-F79; F11.4-F11.7; F18.4-F18.7; F20-F29; F12.4-F12.7; F16.4-F16.7; F19.4-F19.7; F33.2-F33.3; F14.4-F14.7; F00-F09; F60.3-F60.3; F13.4-F13.7; F10.4-F10.7; F17.4-F17.7; F15.4-F15.7; F30-F31    No      
50  13.07.2024     Yes      No      
100  13.07.2024     Yes  F32.2-F32.3; F70-F79; F11.4-F11.7; F18.4-F18.7; F20-F29; F12.4-F12.7; F16.4-F16.7; F19.4-F19.7; F33.2-F33.3; F14.4-F14.7; F00-F09; F60.3-F60.3; F13.4-F13.7; F10.4-F10.7; F17.4-F17.7; F15.4-F15.7; F30-F31    No  until 4 years   
100  13.07.2024     Yes      No  until 4 years   
Reference price: 15,00 EUR 
Under reference price: Yes 
Reference price of daily dose: 0,09 EUR 
Entry/Changing date: April 4, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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