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Pramipexole Teva (pramipexole dihydrochloride monohydrate) – Conditions or restrictions regarding supply and use - N04BC05

Updated on site: 09-Oct-2017

Medication namePramipexole Teva
ATC CodeN04BC05
Substancepramipexole dihydrochloride monohydrate
ManufacturerTeva Pharma B.V.

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

H-4042 Debrecen

Hungary

TEVA Pharmaceutical Works Private Limited Company

H-2100 Gödöllő,

Táncsics Mihály út 82

Hungary

TEVA UK Ltd

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex,

BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5,

Postbus 552,

2003 RN Haarlem

The Netherlands

GALIEN LPS 98 rue Bellocier 89100 Sens France

Teva Czech Industries s.r.o. Ostravska 29, c.p. 305

747 70 Opava-Komarov Czech Republic

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

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 web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

Not applicable.

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