English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Select site language

Raloxifene Teva (raloxifene hydrochloride) – Conditions or restrictions regarding supply and use - G03XC01

Updated on site: 09-Oct-2017

Medication nameRaloxifene Teva
ATC CodeG03XC01
Substanceraloxifene hydrochloride
ManufacturerTeva B.V.

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer(s) responsible for batch release

TEVA Pharmaceutical Works Private Limited Company

Pallagi ùt 13, 4042 Debrecen

Hungary

Teva UK Ltd, Brampton Road

Hampden Park, Eastbourne

East Sussex, BN22 9AG

UK

Pharmachemie B.V.

Swensweg 5, 2031 GA, Haarlem

The Netherlands

GALIEN LPS 98 rue Bellocier 89100 Sens France

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

The PSUR submission schedule for Raloxifene Teva should follow PSUR submission schedule for the reference medicinal product.

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

• Risk Management Plan (RMP)

Not applicable

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed