Results of clinical studies in children have shown that, on average, the younger the patients, the higher the NeoRecormon doses required.

The limited data available from a phase IIa study in HIV-infected patients have shown a clinically non significant 20 % decrease of TPV Cmin.

In conventional safety pharmacology studies in animals, pregabalin was well-tolerated at clinically relevant doses.

The observed rates and incidences in these clinical trials were similar to those expected for the population studied.

Experience from controlled clinical trials is limited to stabilisation of the fracture site using concomitant intramedullary nailing.

In drug-interaction studies, etoricoxib did not have clinically important effects on the pharmacokinetics of prednisone/ prednisolone.

The taper phase regimen used in clinical trials involved decreasing the daily dose by 10 mg at weekly intervals.

Paediatric Patients In clinical studies, 171 paediatric patients received single or multiple doses of CANCIDAS:

The incidence of local skin burning was higher in the tacrolimus treatment groups than in the hydrocortisone group.

Quintanrix was administered to approximately 1,340 healthy infants from 6 weeks of age as a primary vaccination course in several clinical trials.

In these clinical studies, the animal owners gave Zubrin to their dogs, once daily at a dose of 10 mg per kg dog’ s bodyweight with or without food.

In clinical studies 2.1 % of patients treated with 600 mg of efavirenz discontinued therapy because of nervous system symptoms.

Ovarian hyperstimulation syndrome has been observed in approximately 4 % of the patients in clinical studies; most of these cases were mild or moderate in nature.

50/ 94 improvement, the dose may be increased gradually up to a maximum of 4 mg once a day.

Less than 2 % of patients were discontinued from clinical trials due to side effects attributed to PRODUCT NAME .

In clinical studies, the undesirable effects profile was similar in patients with OA or RA treated with etoricoxib for one year or longer.

The CVMP concluded that according to “ current” GCP requirements this pivotal study design has many deficiencies.

The number of patients with hepatitis C responding to treatment with Alpheon and Roferon-A was similar in the clinical study.

In clinical studies of patients with BH4 deficiency treated with a preparation of sapropterin, convulsions and exacerbation of convulsions was observed.

Rash: mild-to-moderate rash has been reported in clinical studies with efavirenz and usually resolves with continued therapy.

Animal studies with Abraxane showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.

Clinical experience with epoetins suggest hypertension and thrombosis risk may be reduced by titrating the dose to maintain M

Pharmacokinetic parameters in Phase 1 patients have remained stable over the long term (through at least 194 weeks).

As clinical efficacy studies were performed with abrupt cessation of treatment, no information is available on whether tapering of the dosage would reduce recurrence rate.

It will meet twice a year and review all clinical trial, pharmaco- epidemiology and post marketing safety data obtained with pimecrolimus.

4 The total number of patients treated with ertapenem in clinical studies was over 2,200 of which over 2,150 received a 1 g dose of ertapenem.

11 As clinical efficacy studies were performed with abrupt cessation of treatment, no information is available on whether tapering of the dosage would reduce recurrence rate.

In clinical studies, administration of single doses of etoricoxib up to 500 mg and multiple doses up to 150 mg/ day for 21 days did not result in significant toxicity.

The documentation submitted with this application consists of literature referring to the use of the originator product Eqvalan, a comparative pharmacokinetic study using Equimectin and Eqvalan, and a supplementary clinical field study.

The following list of adverse reactions is based on experience from clinical trials in adults and on postmarketing experience.

The Company has informed the CHMP that there are no consequences on patients currently included in clinical trials or compassionate use programmes with Valdoxan/ Thymanax.

A total of 345 interferon alpha relapse patients were treated in two clinical trials with t

In the study of patients with a single demyelinating event, Betaferon was shown to reduce the risk of developing clinically defined MS:

In studies performed after the repeated administration of Caelyx to rats and dogs, serious dermal inflammations and ulcer formations were observed at clinically relevant dosages.

Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse event profile for PRODUCT NAME .

In vitro and in vivo preclinical and clinical tests have demonstrated that somatropin is therapeutically equivalent to human growth hormone of pituitary origin.

Apart from these findings, clinical investigations in this age group do not indicate an adverse event profile different from that observed in younger patients.

The response document included a review of clinical data (published data, medical research reports) and microbiological data.

If you take more CRIXIVAN than you should In clinical studies, doses higher than 800 mg every 8 hours have not been shown to have any better effect.

Two large clinical trials evaluating the use of Enbrel in the treatment of CHF were terminated early due to lack of efficacy.

Based on the results of clinical studies, normally no special laboratory evaluations are necessary in addition to careful medical management and supervision of patients.

ed Results from clinical studies in patients The efficacy and safety of Protopy was assessed in more than 13,500 patients treated with tacrolimus ointment in Phase I to Phase III clinical trials.

The MAH conduct a review of the safety data obtained with the current formulation of STAMARIL in all clinical trials.

Population pharmacokinetic evaluation has revealed no evidence of clinically significant race-related differences or effects from smoking upon the pharmacokinetics of aripiprazole.

Respiratory undesirable effects commonly occurred in clinical studies of Caelyx and may be related to opportunistic infections in the AIDS population.

A significant increase in median platelet levels was achieved in a clinical trial in chronic ITP patients (64,000/ µl) although it did not reach normal levels.

As demonstrated in clinical trials, the incidence of thrombocytopaenia was low, and similar in patients treated with eptifibatide or placebo.

6 The table 1 shows the number (%) of patients experiencing bleeding events during the treatment period in the VTE prevention in the two pivotal clinical trials, according to dose.

Of these infants, 1,177 were involved in clinical trials in which most received PROCOMVAX concomitantly with other licensed paediatric vaccines.

Results from clinical studies in patients The efficacy and safety of Protopic was assessed in more than 13,500 patients treated with tacrolimus ointment in Phase I to Phase III clinical trials.