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

Nemdatine (memantine) – Conditions or restrictions regarding supply and use - N06DX01

Updated on site: 08-Oct-2017

Medication nameNemdatine
ATC CodeN06DX01
Substancememantine
ManufacturerActavis Group PTC ehf.

A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

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

Actavis hf. Reykjavikurvegur 78, 200 Hafnarfjörður Iceland

Actavis Group PTC ehf. Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland

Actavis Ltd

BLB016 Bulebel Industrial Estate,

Zejtun ZTN 3000

Malta

Manufacturing Packaging Farmaca (MPF) B.V

Neptunus 12,

Heerenveen, 8448CN,

Netherlands

Manufacturing Packaging Farmaca (MPF) B.V

Appelhof 13,

Oudehaske, 8465RX,

Netherlands

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 restricted prescription (see Annex I: Summary of Product Characteristics, section 4.2).

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.

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