Examples of using Conditional approval in English and their translations into Hungarian
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Conditional approval.
List of establishments, conditional approval.
If clear progress has been made but the plant still does not meet all the applicable requirements,the competent authority may prolong conditional approval.
Recently a formaline-inactivated vaccine has received conditional approval by the competent authorities.
If clear progress has been made, but the establishment still does not meet all of these requirements,the competent authority may prolong conditional approval.
Grades given on the basis of the evaluation(outstanding, positive, conditional approval, negative) are published on the SAC website.
Votubia was originally given‘conditional approval' because there was more evidence to come about the medicine, in particular its long-term effects.
If clear progress has been made, but the establishment still does not meet all of these requirements,the competent authority may prolong conditional approval.
Since Holoclar has been granted a conditional approval, the company that markets Holoclar will provide further data on Holoclar.
If clear progress has been made, but the establishment or plant still does not meet all of these requirements,the competent authority may extend conditional approval.
This medicinal product has been authorised under a so-called‘conditional approval' scheme. This means that further evidence on this medicinal product is awaited.
Conditional approval and accelerated assessment are two of the Agency's main mechanisms to facilitate earlier access by patients to medicines that fulfil unmet medical needs.
Rail Cargo Austria must remove structural links and review contractual links to GySEV-the European Commission gives conditional approval for the consortium of the two undertakings purchasing MÁV Cargo for HUF 102,5 billion.
Votrient was originally given‘conditional approval' because there was more evidence to come about the medicine, in particular in the treatment of renal cell carcinoma.
Since Zalmoxis has been granted a conditional approval, the company that markets Zalmoxis will provide the results of an ongoing study in high-risk acute leukaemia patients.
Sutent was originally given‘conditional approval' because there was more evidence to come about the medicine, in particular in the treatment of renal cell carcinoma.
Since Deltyba has been granted a conditional approval, the company that markets Deltyba will carry out further studies to confirm the long-term effectiveness and safety of Deltyba.
Since Ocaliva has been granted a conditional approval, the company that markets Ocaliva will provide additional data from two studies to confirm the effectiveness and safety of the medicine.
Intelence was originally given‘conditional approval' because there was more evidence to come about the medicine, in particular regarding its use in combination with protease inhibitors other than darunavir.
Since Tagrisso has been granted a conditional approval, the company that markets Tagrisso will provide the findings of a study comparing Tagrisso with platinum-based chemotherapy(standard treatment for NSCLC).
Since Natpar has been granted a conditional approval, the company that markets Natpar will conduct a further study to confirm the benefits and risks of the medicine and the appropriateness of the once-a-day dosing schedule.
Since Lartruvo has been granted a conditional approval, the company that markets Lartruvo will provide additional data from an ongoing study in order to further confirm the efficacy and safety of the medicine.
Since Sirturo has been granted a conditional approval, the company that markets Sirturo will provide additional data on the medicine's benefits and safety when used with different combinations of medicines.
Since Translarna has been granted a conditional approval, the company that markets Translarna shall provide further data on the effectiveness and safety of the medicine from an ongoing confirmatory study in DMD patients with the nonsense mutation.
Since Blincyto has been granted a conditional approval, the company that markets Blincyto will provide data from a larger study comparing the effectiveness Blincyto to standard chemotherapy(cancer medicines) in Ph- B-precursor ALL patients.
Since Zykadia has been granted a conditional approval, the company that markets Zykadia will provide results of a further study comparing Zykadia with other cancer medicines(chemotherapy) in patients with ALK-positive NSCLC previously treated with crizotinib.
Since Pandemic influenza vaccineH5N1 MedImmune has been granted a conditional approval, the company that markets Pandemic influenza vaccine H5N1 MedImmune will conduct studies to gather more information on its effectiveness and side effects during its use in a pandemic as well as its side shelf life.
Since Darzalex has been granted a conditional approval, the company that markets Darzalex will provide the results of two studies comparing the effect of Darzalex used in combination with other cancer treatments(i.e. lenalidomide and dexamethasone, or bortezomib and dexamethasone) with that of these other treatments given on their own.
Since Cometriq has been granted a conditional approval, the company that markets Cometriq will provide information from a study comparing the safety and effectiveness of different doses of Cometriq, and its benefit in patients lacking the RET gene mutation or whose cancer has changes in another family of genes called RAS.
Since Bosulif has been granted a conditional approval, the company that markets Bosulif will carry out and submit the results of a larger study with Bosulif in patients with Ph+ CML previously treated with one or more tyrosine kinase inhibitors and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.