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

NutropinAq (somatropin) – Conditions or restrictions regarding supply and use - H01AC01

Updated on site: 08-Oct-2017

Medication nameNutropinAq
ATC CodeH01AC01
Substancesomatropin
ManufacturerIpsen Pharma

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

Genentech Inc.

1 DNA Way

South San

Francisco CA

94080-4990 USA

Name and address of the manufacturer responsible for batch release

Ipsen Pharma Biotech SAS Parc d‟Activités du Plateau de

Signes Chemin Départemental no 402

83870 Signes France

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Phamacovigilance system

The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.

Periodic Safety Update Reports (PSURs)

The marketing authorization holder shal submit periodic safety update reports for this product in accordance with the requirements set out 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 EFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

At the request of the European Medicines Agency;

Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as a result of an important (pharmacovigilance or risk minimisation) milestone being reached.

If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.

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