When initiating Stalevo therapy for patients currently treated with entacapone and levodopa/ carbidopa in doses not equal to Stalevo 50 mg/ 12.5 mg/ 200 mg, (or 100 mg/ 25 mg/ 200 mg, or 150 mg/ 37.5 mg/ 200 mg or 200 mg/ 50 mg/ 200 mg) tablets, Stalevo dosing should be carefully titrated for optimal clinical response.

When initiating Stalevo therapy for patients currently treated with entacapone and levodopa/ carbidopa in doses not equal to Stalevo 100 mg/ 25 mg/ 200 mg, (or 50 mg/ 12.5 mg/ 200 mg, or 150 mg/ 37.5 mg/ 200 mg or 200 mg/ 50 mg/ 200 mg) tablets, Stalevo dosing should be carefully titrated for optimal clinical response.

When initiating Stalevo therapy for patients currently treated with entacapone and levodopa/ carbidopa in doses not equal to Stalevo 150 mg/ 37.5 mg/ 200 mg, (or 50 mg/ 12.5 mg/ 200 mg, or 100 mg/ 25 mg/ 200 mg or 200 mg/ 50 mg/ 200 mg) tablets, Stalevo dosing should be carefully titrated for optimal clinical response.

Posology for the treatment of uncomplicated cystitis The CHMP asked the applicant/ MAH to provide reassurance that a 100 mg BID dose for 3 days (currently validated in some EU countries) is adequate for treating uncomplicated cystitis in young women with regards to the epidemiological figure pertaining to the bacteria potentially involved and with regards to the treatment response as compared to the proposed higher dose of 250 mg- 500 mg BID.

p < 0.05, abatacept vs. placebo. ** p < 0.01, abatacept vs. placebo. *** p < 0.001, abatacept vs. placebo. a Fixed dose approximating 10 mg/ kg (see section 4.2). b Concurrent DMARDs included one or more of the following: methotrexate, chloroquine/ hydroxychloroquine, sulfasalazine, leflunomide, azathioprine, gold, and anakinra. c Major clinical response is defined as achieving an ACR 70 response for a continuous 6-month period. d After 6 months, patients were given the opportunity to enter an open-label study.

A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/ hydrochlorothiazide 150 mg/ 12.5 mg or to irbesartan 150 mg and systematically force- titrated (before assessing the response to the lower dose) after one week to irbesartan/ hydrochlorothiazide 300 mg/ 25 mg or irbesartan 300 mg, respectively.

As the cardiovascular risks of celecoxib were increased with the 400 mg twice daily dose in the APC trial (section 5.1), the response of the FAP patient to celecoxib should be re-examined periodically in order to avoid unnecessary exposure in FAP patients for whom celecoxib is not effective (sections 4.2, 4.3, 4.8 and 5.1)

As the cardiovascular risks of celecoxib were increased with the 400 mg twice daily dose in the APC trial (section 5.1), the response of the FAP patient to celecoxib should be re-examined periodically in order to avoid unnecessary exposure in FAP patients for whom celecoxib is not effective (sections 4.2, 4.3, 4.8 and 5.1).

5.1 Pharmacodynamic properties au The immune response after a three-dose primary vaccination course was evaluated in five trials: 297 infants were evaluated after vaccination at 6, 10 and 14 weeks of age, 685 after vaccination at 2, 4, and 6 months of age and 107 after vaccination at 3, 4 and 5 months of age. Results from different

Where a Member State believes that a low-risk biocidal product which has been registered by another Member State does not comply with the definition provided for in Article 2(1)(b), it may provisionally refuse registration thereof and shall immediately communicate its concerns to the competent authority responsible for the verification of the dossier.

80 mg at week 0 followed by 40 mg at week 2. In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at week 2, can be used with the awareness that the risk for adverse events is higher during induction. na

Data on the development of anti-panitumumab antibodies has been evaluated using two different immunoassays (an ELISA which detects high-affinity antibodies, and a Biosensor Immunoassay which detects both high and low-affinity antibodies), results from these assays indicated that the overall incidence of a post-dose anti-panitumumab antibody response was low.

The median time to relapse among PASI responders ranged from 58 to 74 days following the last Raptiva dose in the initial treatment period. In study IMP24011, approximately half of the patients (46.8 %) who were partial responders (50 % to 74 % improvement on PASI, similar to PGA good) after 12 weeks of Raptiva treatment achieved a PASI 75 response at week 24.

Even with these dose adjustments for adults, some patients with hepatic impairment may have higher or lower than anticipated amprenavir and/ or ritonavir plasma concentrations as compared to patients with normal hepatic function, due to increased inter-patient variability (see section 5.2), therefore a close monitoring of safety and virologic response is warranted.

Even with these dose adjustments for adults with, some patients with hepatic impairment may have higher or lower than anticipated amprenavir and/ or ritonavir plasma concentrations as compared to patients with normal hepatic function, due to increased inter-patient variability (see section 5.2), therefore a close monitoring of safety and virologic response is warranted.

8 were 36 % (19/ 53) and 70 % (7/ 10), respectively. Although the doses of prior antifungal therapies in 5 patients enrolled as refractory were lower than those often administered for invasive aspergillosis, the favourable response rate during therapy with caspofungin was similar in these patients to that seen in the remaining refractory patients (2/ 5 versus 17/ 48, respectively).

If on the basis of any release notified under Part B of Directive 90/220/EEC, or on substantive, reasoned scientific grounds, the person responsible for the dossier considers that the placing on the market or the use of the additive does not pose a risk to human health, animal health and the environment, he may propose not to comply with one or more of the requirements of Annex III B.

It was therefore concluded that the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided the product is used as indicated by the Marketing Authorisation Holders in their responses to questions by the Committee, i. e. a dose of 7 mg/ kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.

It is concluded from the above evaluation that the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided the product is used as indicated by the Marketing Authorisation Holders in their responses to questions by the Committee, i. e. a dose of 7 mg/ kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.

A peri-postnatal study has not been conducted with Suboxone; however, maternal oral administration of buprenorphine at high doses during gestation and lactation resulted in difficult parturition (possible as a result of the sedative effect of buprenorphine), high neonatal mortality and a slight delay in the development of some neurological functions (surface righting reflex and startle response) in neonatal rats.

such applications, accompanied by the monographs and identification notes provided for in Articles 9n and 9o respectively, shall be addressed by the person responsible for the dossier on the basis of which the former authorization was given or by his successor or successors, via the Member State acting as rapporteur, to the Commission, sending copies to the other Member States, which shall acknowledge receipt thereof.

such applications, accompanied by the monographs and the identification notes provided for in Articles 9n and 9o respectively, shall be addressed by the person responsible for the dossier on the basis of which the former authorization was given or by his successor or successors, via the Member State acting as rapporteur, to the Commission, sending copies to the other Member States, which shall acknowledge receipt thereof.

such applications, accompanied by the monographs and the identification notes provided for in Articles 9n and 9o respectively, shall be addressed by the person responsible for the dossier on the basis of which the former authorization was granted or by his successor or successors, via the Member State acting as rapporteur, to the Commission, sending copies to the other Member States, which shall acknowledge receipt thereof.

Patients with ≥ one dose of study drug with evaluable baseline liver biopsies and baseline Knodell Histological Activity Index (HAI) score > 3. 2 Histological response defined as a ≥ 2 point decrease in Knodell Necroinflammatory Score from baseline with no worsening of the Knodell Fibrosis Score. 3 For Ishak Fibrosis Score, improvement measured as ≥ 1 point reduction in Ishak Fibrosis Score from baseline to week 52. *p = 0.0024

Whereas the Commission must withdraw provisional authorisations for coccidiostats and other medicinal substances for which there have been no new applications for authorisation before 1 October 1998 accompanied by a monograph and identification note addressed by the person responsible for the dossier on the basis of which the former authorisation was granted or by his successor or successors, via the Member State acting as rapporteur, to the Commission;

Whereas there should be drawn up in the form of an Annex to this Directive, first a list of additives for which authorization to put them into circulation is granted to persons responsible who alone are entitled to put the additives in question into circulation, second, a list of other additives which may be put into circulation by any person provided that they are additives which meet the specifications in the dossiers on the basis of which they have been authorized;

Intent to Treat (ITT) population b p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p < 0.0001 c Response population includes patients who had measurable disease at baseline and received at least 1 dose of study drug. d p-value from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history *CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+) NA = not applicable, NE = not estimated

The assessment of the risk presented by toltrazuril sulfone to terrestrial plants and to groundwater demonstrated that the use of products containing toltrazuril is acceptable and the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided the product is used as indicated by the Marketing Authorisation Holders in their responses to questions by the Committee, i. e. a dose of 7 mg/ kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.

In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with Enbrel alone (25 mg twice weekly), methotrexate alone (7.5 to 20 mg weekly, median dose 20 mg), and of the combination of Enbrel and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 disease-modifying antirheumatic drug (DMARD) other than methotrexate.

(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;

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;

the relationship between dose, dose rate, and response; photorepair, adaptation, and protection;