Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1042311
Name of medicinal product: CARBALEX 200 MG
Active substances:
Carbamazepine
Estonian, English, Latin
ATC code: N03AF01
Dosage form: tablet
Route of administration: oral use
Strengh: 200mg
Amount in package: 50TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Epilepsy. Trigeminal and glossopharyngeal neuralgia. Diabetic neuropathy. Alcohol withdrawal syndrome.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated May 31, 2022)
Package information leaflet (PIL): EST  (last updated May 31, 2022)
Labelling:  (last updated May 31, 2022)
Last imported to Estonia: April 1, 2024
Marketing authorization holder: G.L. Pharma GmbH 
Marketing authorization number: 391302 
Marketing authorization issued on: August 16, 2002 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
50  05.04.2024     Yes      No      
100  05.04.2024     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  Psühhiaater  Yes  until 4 years   
90  05.04.2024     Yes  G50.0-G50.0    No      
90  05.04.2024     Yes  G50.0-G50.0    No  from 63 years   
100  05.04.2024     Yes      No  until 4 years   
90  05.04.2024     Yes  G50.0-G50.0    No  4 years - 17 years   
100  05.04.2024     Yes  G40-G40  Neuroloog  Yes      
100  05.04.2024     Yes  G50.0-G50.0    No  until 4 years   
75  05.04.2024     Yes  G50.0-G50.0    No      
100  05.04.2024     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  Psühhiaater  Yes      
90  05.04.2024     Yes  G50.0-G50.0    No      
100  05.04.2024     Yes  G40-G40  Neuroloog  Yes  until 4 years   
Reference price: 3,50 EUR 
Under reference price: No 
Reference price of daily dose: 0,35 EUR 
Entry/Changing date: March 4, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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