A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Teva Pharmaceutical Works Co. Ltd.
Pallagi Street 13
TEVA Pharmaceutical Works Private Limited Company
Táncsics Mihály út 82
- Mirapexin - pramipexole dihydrochloride monohydrate
- Pramipexole accord - pramipexole dihydrochloride monohydrate
- Sifrol - pramipexole dihydrochloride monohydrate
- Oprymea - pramipexole dihydrochloride monohydrate
Prescription drugs listed. Substance: "Pramipexole dihydrochloride monohydrate"
TEVA UK Ltd
2003 RN Haarlem
GALIEN LPS 98 rue Bellocier 89100 Sens France
Teva Czech Industries s.r.o. Ostravska 29, c.p. 305
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to medical prescription.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
•Periodic Safety Update Reports
At the time of granting the marketing authorisation, the submission of periodic safety update reports is not required for this medicinal product. However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
•Risk Management Plan (RMP)