The need to reduce by 10 mg kg the dose if serum creatinine rises Adults 33 above baseline and creatinine clearance LLN (90 ml min) Paediatrics either ULN or creatinine clearance falls to LLN at two consecutive visits.

Testosterone levels are often below the normal range in patients with end stage renal disease.

The need t o interrupt treatment after a dose reduction if serum creatinine rises Adults and Paediatrics remain 33 above baseline or creatinine clearance LLN (90 ml min)

During clinical trials, increases in serum creatinine of 33 on 2 consecutive occasions, sometimes above the upper limit of the normal range, occurred in about 36 of patients.

Likelihood of continuation of dumping in the framework of the expiry review

Normal value was constructed on the basis set out in recital 22 above.

A. NORMAL VALUE

normal

above normal baseline

Certain conditions can make you more likely to suffer from low blood sugar while you are taking Avaglim.

For adults, this is any level above 17 μmol l and for newborns 340 µmol l and critical hyperbilirubinemia 425 µmol l.

Normal value was established in line with the general methodology as explained under paragraphs (24) to (28).

normal above normal baseline

The normal value and export prices were compared on an ex works basis.

The comparison between normal value and export price was made on an ex works basis.

However, the normal value which was compared to the export price was established on the basis of the net domestic sales price excluding all taxes.

Peripheral B cell counts declined below normal following completion of the first dose of MabThera.

and 2 x baseline value Each patient may be represented in one or more category.

(a) Normal value for non WTO members

Therefore, normal value had to be constructed in accordance with the provisions set in recital 71.

Normal value was established by using the methodology outlined in recitals 43 to 47 and 53 to 59.

With regard to these arguments, as set out in recital 37 above, constructed normal value with the profit on domestic sales during the original investigation in Taiwan was used because the domestic sales in the Indonesian market during the investigation period were considered insufficient for establishing normal value on the basis of sales prices.

Based on all these findings and events, it is likely that in the event of resumption of exports by Chinese exporters to the EU, these exports would be priced below the normal value.

In the absence of any comments, the provisional findings concerning normal value, as set out in recital 36 of the provisional Regulation are confirmed.

In the original investigation normal value was established on the basis of prices or constructed value in Mexico, which was found to be an appropriate market economy analogue country for the PRC.

In accordance with Article 2(11) of the basic Regulation, the normal value was compared to the export price.

Based on the normal value calculated for the analogue country, these imports would be dumped at significantly high levels.

Laboratory Value

Therefore, the normal value was adjusted accordingly.

In the absence of any comments, the provisional findings concerning normal value as set out in recitals 20 to 27 of the provisional Regulation are confirmed.

In the absence of a reliable export price for these Chinese exporting producers, due to the existence of the undertakings in this case, the Commission considered another possibility to establish the export price for the purpose of assessing whether dumping is likely to continue.

An adjustment was made to the normal value to exclude the value of any printer interface.

For paediatric patients, the dose may be reduced by 10 mg kg if estimated creatinine clearance decreases below the lower limit of the normal range ( 90 ml min) and or serum creatinine levels rise above the age appropriate upper limit of normal at two consecutive visits.

Furthermore, the normal value has now been calculated taking into account the SG A incurred on the domestic market, and the profit margin applied has been adjusted to reflect the profit margin obtained in the ordinary course of trade on the domestic market.

Normal value based on actual domestic prices

For the remaining types of farmed salmon exported by these companies, normal value had to be constructed following the methodology explained in recital 26.

On this basis normal value as established for the analogue country was compared with the export price as contained in the applicant s review request.

It also appeared, because of a more complex manufacturing process, that normal value of this product type would be considerably higher than normal value of the other product types.

As far as the influence of raw material prices on the normal value is concerned, the conclusions of recital (157) apply also in the case of Taiwan.

Therefore, no normal value could be established for the IP.

It is to be recalled that there has been a considerable reduction in the normal value of the product concerned since the IP of the original investigation.

For four exporting producers normal value was established in line with the methodology set out in recitals 65 to 71.

Anti Dumping measures address the import of goods to the European Union at less than their normal value in their home market usually as a result of the lack of competition and or state interference in the production process that allows an exporter to artificially lower the cost of an export.

In clinical trials, decreases in LVEF of 20 and below the lower limit of normal occurred in approximately 2 of SUTENT treated GIST patients, 4 of cytokine refractory MRCC patients, 2 of placebo treated patients.

Considering the above, for all product types mentioned in recital 29, normal value was constructed on the basis of Article 2(3) of the basic Regulation.