Medicinal product name Pregabalin Mylan
Pharmaceutical form Capsule, hard
Strength 75 mg 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.)
 Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website
ATC code N03AX16 Antiepileptics

Important notice

Additional information regarding the use for persons aged 75+

If used as "ANTIEPILEPTICS"
SubstanceClassComment
PregabalinumCSuitable for older persons, with specific cautions. Sedative. Reduce the dose in even mild renal insufficiency. May prolong the QTc interval. Note especially central nervous system adverse effects. Addiction might develop.

Medicinal products (1)

Availability of medicinal product Wholesalers Package size, content Primary packaging Maximum admissible pharmacy price (€ incl. VAT) Product No. Labelling
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N100
(75 mg)
PVC/PVDC/Al blister    EU/1/15/997/018  Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website

Registration information

Marketing authorisation No. EU/1/15/997/018
Date of authorisation Jun 25, 2015
Marketing authorisation holder, country Mylan S.A.S, France