SIFROL

This brand name is authorized in Austria, Australia, Brazil, Germany, Estonia, Finland, France, Croatia, Ireland, Israel, Lithuania, Mexico, Netherlands, Poland, Singapore, Tunisia

Active ingredients

The drug SIFROL contains one active pharmaceutical ingredient (API):

1 Pramipexole
UNII 3D867NP06J - PRAMIPEXOLE DIHYDROCHLORIDE

Pramipexole is a dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D3 receptors, and has full intrinsic activity. Pramipexole alleviates parkinsonian motor deficits by stimulation of dopamine receptors in the striatum. Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.

Read about Pramipexole

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
SIFROL Tablet European Medicines Agency (EU) MPI, EU: SmPC
SIFROL Prolonged-release tablet European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
N04BC05 Pramipexole N Nervous system → N04 Anti-parkinson drugs → N04B Dopaminergic agents → N04BC Dopamine agonists
Discover more medicines within N04BC05

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 3418X, 3419Y, 3420B, 3421C, 3422D, 5143Q, 5145T, 9151P, 9152Q, 9153R, 9393J, 9394K
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 504503801113217, 504503802111218, 504503803116213, 504503805119317, 504503807111313, 504503809114311, 504503811119315
Country: DE Bundesinstitut für Arzneimittel und Medizinprodukte Identifier(s): 00267737, 00268234, 00268240, 00268257, 00434425, 00434431, 00522750, 00578176, 01299811, 01836930, 02460349, 02558692, 03319699, 03319707, 03420748, 03420777, 03864184, 04038100, 04038123, 06439725, 06439748, 07562445, 07562451, 07568086, 07764137, 07764143, 08997872, 08997889, 11080166, 14354339, 14354374, 15637097, 15996703, 16698132, 16698149, 16869177, 16869183, 17545117
Country: EE Ravimiamet Identifier(s): 1204658, 1204669, 1204670, 1204681, 1204692, 1204704, 1204715, 1204726, 1204759, 1204760, 1455870, 1455881, 1455892, 1455904, 1455915, 1455926, 1455937, 1455948, 1455959, 1455960, 1455971, 1455982, 1455993, 1456006, 1456017, 1482588, 1482599, 1482601, 1482612, 1482623, 1482634
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 044728, 044739, 044752, 050836, 050847, 062410, 140327, 141432, 515477, 515942
Country: FR Base de données publique des médicaments Identifier(s): 60267171, 66881233, 67432729, 67527910, 69016117, 69922895
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 6142, 6143, 6828, 6829, 6830
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1030596, 1030597, 1030598, 1030599, 1030600, 1030601, 1030602, 1030603, 1030604, 1030605, 1051350, 1051351, 1051352, 1051353, 1051354, 1051355, 1051356, 1051357, 1051358, 1051359, 1051360, 1051361, 1051362, 1051363, 1051364, 1056016, 1056017, 1056018, 1056019, 1056020, 1056021
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 037M2010, 062M99
Country: NL Z-Index G-Standaard, PRK Identifier(s): 49433, 49468, 91235, 91243, 91251, 91278, 94129
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100316450, 100316467, 100316473, 100316496, 100316504, 100316510, 100316527, 100316533, 100316540, 100316556, 100316562
Country: SG Health Sciences Authority Identifier(s): 11250P, 11253P, 13928P, 13930P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 115330210, 115330211, 11533022, 11533023, 11533024, 11533025, 11533026, 11533027, 11533028, 11533029

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