The ADI for oxydemeton-methyl is 0,0003 mg/kg bw (JMPR 1989), the ARfD is 0,005 mg/kg bw, the ADI for dimethoate is 0,002 mg/kg bw (JMPR 1996), the ARfD is 0,03 mg/kg bw.

The ADI for lindane is 0,001 mg/kg bw/day (JMPR 1997), no acute reference dose being considered necessary, the ADI for parathion is 0,004 mg/kg bw/day (JMPR 1995), the ARfD being 0,01 mg/kg bw/day (JMPR 1995), the ADI for permethrin is 0,05 mg/kg bw/day (JMPR 1999), no ARfD being considered necessary, the ADI for quintozene is 0,01 mg/kg bw/day (JMPR 1995), no ARfD being considered necessary.

The acute reference dose for bentazone was established at 0,25 mg/kg bw/day.

These reports fixed the acceptable daily intake (ADI) and, if necessary, the acute reference dose (ARfD) for the substances concerned.

These reports fixed the Acceptable Daily Intake (ADI) and if necessary, the Acute Reference Dose (ARfD) for the substances concerned.

It has not been demonstrated for the proposed uses that consumers might not be exposed to amitraz exceeding the Acute Reference Dose.

In its opinion of 28 January 2000 (8), the Committee noted that an acute dietary risk assessment for consumers should be conducted and an acute reference dose should be defined.

the level, consistency and duration of the effect sought in relation to the dose in comparison with a suitable reference product or products and an untreated control;

When performing a bioassay, every test run requires a series of reference concentrations of TCDD or a dioxin/furan mixture (full dose-response curve with a R2 > 0,95).

to consider whether it would be appropriate to establish an acute reference dose for sulfosulfuron;

The acute reference dose for pymetrozine was established at 0,1 mg/kg bw/day.

If only water hardness lower than 2,5 mmol CaCO3/l are included in the recommendations, the maximum dosage recommended for "normally soiled" shall be lower than the reference dosage mentioned in the previous paragraph.

The reference product in SE is Ventoline Evohaler, 0.1 mg/ dose (GlaxoSmithKline AB).

product, during the bioequivalence study, and the test product was administered at greater than the recommended treatment dose in the field study.

Each dose of 1 ml of inactivated vaccine contains: Porcine circovirus type 2 ORF2 protein: minimum RP* 1.0, maximum RP* 3.75 * Relative Potency (ELISA test) by comparison with a reference vaccine. Adjuvant: Carbomer

In approximately half the case of flares exceeding 10 times the upper limit of normal, Pegasys dosing was reduced or withheld until the transaminase elevations subsided, while in the rest therapy was continued unchanged.

As stated earlier, the Applicant provided initial repriming studies on the test product which were complemented with a repriming study with the reference product and the CHMP considered that while the data demonstrate the effect of the position of the MDI on the deposited dose, this effect is observed in both the test and the reference product.

The marketing applications were submitted as hybrid applications under Article 10(3) of Directive 2001/ 83/ EC and the EU reference product is Sultanol Dosier-Aerosol 100 μ g/ dose, Druckgasinhalation, suspension, (GlaxoSmithKline).

The Applicant provided in vitro data to demonstrate the in vitro equivalence between the test product and the reference product and presented justifications for the pooling of the data including a second pooling using the following grouped stages:

the specific name of the active component(s) according to its (their) enzymatic activity(ies) in accordance with the authorization given, the identification number according to the International Union of Biochemistry, the activity units (activity units per g or activity units per ml), the additive's EC registration number, the name or business name and the address or registered place of business of the manufacturer if he is not responsible for the particulars on the label, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use specifying in particular the recommended dose, in the form of a range if appropriate, in accordance with the percentage(s) by weight of target feed material(s) per kilogram of the whole feedingstuff in accordance with the requirements laid down on a case-by-case basis in the authorization for the additive and, where applicable, indication of any particular significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization of the additive;

(units of activity per gram or units of activity per millilitre), the EC registration number of the additive, the name or business name and the address or registered place of business of the person responsible for the particulars on the label, the name or business name and the address or registered place of business of the manufacturer, if he is not responsible for the particulars on the label, the approval number assigned to the establishment or the intermediary pursuant to Article 5 of Directive 95/69/EC, the expiry date of the guarantee or the storage life from the date of manufacture, the batch reference number and the date of manufacture, the directions for use specifying in particular the recommended dose, in the form of a range if appropriate, in accordance with the percentage(s) by weight of target feed material(s) per kilogram of the whole feedingstuff in accordance with the requirements laid down on a case-by-case basis in the authorization for the additive and, where applicable, safety recommendations as provided for in the authorization for the additive, the net weight and, in the case of liquid additives, either the net volume or the net weight, where appropriate indication of special significant characteristics due to the manufacturing process, in accordance with the provisions concerning labelling in the authorization for the additive;