Drug information for MIRAPEX ER

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, EXTENDED RELEASE; ORAL 0.375MG Prescription  (Reference Drug) PRAMIPEXOLE DIHYDROCHLORIDE pramipexol BOEHRINGER INGELHEIM 22421
2010-08-20 Review

2010-08-20 Summary Review

2010-07-22 Label

2010-07-15 Letter

2010-02-26 Letter

2010-02-25 Label
TABLET, EXTENDED RELEASE; ORAL 0.75MG Prescription   PRAMIPEXOLE DIHYDROCHLORIDE pramipexol BOEHRINGER INGELHEIM   "
TABLET, EXTENDED RELEASE; ORAL 1.5MG Prescription   PRAMIPEXOLE DIHYDROCHLORIDE pramipexol BOEHRINGER INGELHEIM   "
TABLET, EXTENDED RELEASE; ORAL 2.25MG Prescription   PRAMIPEXOLE DIHYDROCHLORIDE pramipexol BOEHRINGER INGELHEIM   "
TABLET, EXTENDED RELEASE; ORAL 3.75MG Prescription   PRAMIPEXOLE DIHYDROCHLORIDE pramipexol BOEHRINGER INGELHEIM   "
TABLET, EXTENDED RELEASE; ORAL 3MG Prescription   PRAMIPEXOLE DIHYDROCHLORIDE pramipexol BOEHRINGER INGELHEIM   "
TABLET, EXTENDED RELEASE; ORAL 4.5MG Prescription   PRAMIPEXOLE DIHYDROCHLORIDE pramipexol BOEHRINGER INGELHEIM   "
TABLET, EXTENDED RELEASE; ORAL 0.375MG Prescription   PRAMIPEXOLE DIHYDROCHLORIDE pramipexol BOEHRINGER INGELHEIM 22514
2010-09-03 Review

2010-09-03 Summary Review

2010-03-26 Label

2010-03-24 Letter
TABLET, EXTENDED RELEASE; ORAL 0.75MG Prescription   PRAMIPEXOLE DIHYDROCHLORIDE pramipexol BOEHRINGER INGELHEIM   "
TABLET, EXTENDED RELEASE; ORAL 1.5MG Prescription   PRAMIPEXOLE DIHYDROCHLORIDE pramipexol BOEHRINGER INGELHEIM   "
TABLET, EXTENDED RELEASE; ORAL 3MG Prescription   PRAMIPEXOLE DIHYDROCHLORIDE pramipexol BOEHRINGER INGELHEIM   "
TABLET, EXTENDED RELEASE; ORAL 4.5MG Prescription   PRAMIPEXOLE DIHYDROCHLORIDE pramipexol BOEHRINGER INGELHEIM   "

Drug Adverse Effects information for MIRAPEX ER

Role code Indications Reaction # Reports
C PARKINSON'S DISEASE CELLULITIS 1
C PARKINSON'S DISEASE FALL 1
C PARKINSON'S DISEASE FROSTBITE 1
C PARKINSON'S DISEASE HIP FRACTURE 1
C PARKINSON'S DISEASE HOT FLUSH 1
C PARKINSON'S DISEASE HYPERHIDROSIS 1
C PARKINSON'S DISEASE MULTIPLE INJURIES 1
C PARKINSON'S DISEASE MUSCLE SPASMS 1
C PARKINSON'S DISEASE NIGHTMARE 1
C PARKINSON'S DISEASE PAIN 1
C PARKINSON'S DISEASE PALPITATIONS 1
C PARKINSON'S DISEASE PARKINSON'S DISEASE 1
C PARKINSON'S DISEASE PYREXIA 1
C PARKINSON'S DISEASE ROAD TRAFFIC ACCIDENT 1
C PARKINSON'S DISEASE SLEEP ATTACKS 1
C PARKINSON'S DISEASE SUICIDAL IDEATION 1
C PARKINSON'S DISEASE WITHDRAWAL SYNDROME 1
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