Übersetzung für "Zugelassenes arzneimittel" in Englisch

For a product already authorized as a medicinal product, a reference to information previously submitted will usually be sufficient.

This is an authorized drug product.

The studies described below (GOAL, TORCH and SMART) were carried out with this same fixed-dose combination, salmeterol xinafoate and fluticasone propionate, but studied a previously authorised product; the studies described were not carried out with Airexar Spiromax.

Taking into account the PRAC Assessment Report on the PSUR(s) for asparaginase (centrally authorised product), the scientific conclusions of CHMP are as follows:

The review also included a centrally-authorised medicine, ellaOne, which contains ulipristal acetate and was granted a marketing authorisation in the EU in 2009.

The studies described were carried out with a previously authorised product available in three different strengths; the studies were not carried out with

The women were given either Halaven or another approved cancer medicine chosen by their doctor.

Zinbryta (daclizumab) is a centrally authorised medicinal product indicated at the start of this review in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).

Zydelig (idelalisib) is a centrally authorised product and is currently indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.

Esmya (ulipristal acetate, 5 mg) is a centrally authorised medicinal product indicated for pre-operative treatment, as well as intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

The scope of the procedure includes nationally-authorised medicinal products and a centrally-authorised medicinal product, Colobreathe (dry powder for inhalation), authorised in February 2012.

Zydelig (Idelalisib) is a centrally authorised product and is currently indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.

Enzepi has been shown to be as effective as an already authorised medicine containing pancreas powder and used in pancreatic insufficiency.

Once a day the dogs were given either Cimalgex or firocoxib, a medicine authorised for use for this condition.

Zinbryta (daclizumab) is a centrally authorised medicinal product indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).

When an authorised product previously placed on the market in the authorising Member State is no longer actually present on the market for a period of three consecutive years, the authorisation for that product shall cease to be valid.

When an authorised veterinary medicinal product previously placed on the market in the authorising Member State is no longer actually present on the market in that Member State for a period of two consecutive years, the authorisation shall cease to be valid."

When an authorised product previously placed on the market in the authorising Member State is no longer actually present on the market for a period of two consecutive years, the authorisation for that product shall cease to be valid."

Where the application for a compulsory licence concerns a medicinal product authorised in accordance with Article 6 of Directive 2001/83/EC, the provisions of Article 24(4) and (5) and of Article 14(4) and (5) of Regulation (EC) No 726/2004 of the European Parliament and the Council5 shall not apply.

Where a marketing authorisation holder intends to include information on a medicinal product authorised in accordance with this Regulation in an Internet website registered in accordance with Article 100h of Directive 2001/83/EC, it shall submit the information to the Agency for the application of Article 20b of this Regulation prior to it being made available, and inform the Agency of the Member State where the Internet website is intended to be or is registered.

If there is no authorised medicinal product in a Member State for a condition affecting a non food-producing species, the veterinarian may, by way of exception, particularly in order to avoid causing unacceptable suffering to the animal concerned, under his/her personal responsibility, treat the animal(s) with:

If there is no authorised medicinal product in a Member State for a condition affecting a species of pet animal or animals kept in zoos or circuses, the veterinarian may, particularly in order to avoid causing unacceptable suffering to the animal concerned, under his/her personal responsibility, treat the animal(s) with:

The Commission does not accept amendment 42, 56 and 58 aimed at obliging the package leaflet of all new medicinal products authorised by the Agency to include the phrase ‘newly authorised medicinal product’ as well as an invitation to patients to report any adverse effects and an obligation to the marketing authorisation holder to handle any information reported directly by the patient.

When an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other indications, the marketing authorisation holder should be obliged to place the product on the market, taking into account the paediatric information, within two years of the date of approval of the indication.

An optional procedure should be established to make it possible to obtain a single Community-wide opinion for a nationally authorised medicinal product when data on the paediatric population following an agreed paediatric investigation plan form part of the marketing authorisation application.

This procedure is based on the principle that a product authorised in one Member State should be recognised by another.