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Language - Leaflet type
ROWACHOL Oral Drops Solution - english - Product characteristics
from the same producer
ACETYCYSTEINE 300 Milligram - 300 Milligram
BECLOMETHASONE Suppositories 0.25 Milligram - 0.25 Milligram
CALAMINE Cutaneous Suspension
CARBOSAN Gel 2 %w/w - 2 %w/w
LACTULOSE Oral Solution
MAGNESIUM VERLA 5 MMOL GRANULES FOR ORAL SOLUTION - 5 mMol.
MEFAC Capsule 250 Milligram - 250 Milligram
MEFAC Tablets 500 mg Milligram - 500 mg Milligram
METOCYL Tablets 10 Milligram - 10 Milligram
METOCYL Capsule 30 Milligram - 30 Milligram
OMEPRAZOLE Tablets Gastro-Resistant 20 Milligram - 20 Milligram
ONDANSETRON Solution for Injection 4mg/2ml Mg/Ml - 4mg/2ml Mg/Ml
with the same active ingredient
ROWACHOL Capsules Gastro-Resistant
On 9 December 2011, orphan designation (EU/3/11/937) was granted by the European Commission to Edison Europe Holding BV, the Netherlands, for alpha-tocotrienol quinone for the treatment of Leigh syndrome.
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)
Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on refined Buglossoides oil as a novel food ingredient (NFI) in the context of Regulation (EC) No 258/97. The NFI is produced from the seeds of Buglossoides arvensis (L.) I. M. Johnst, using processes conventionally used for edible oil production. The main fatty acids (FAs) contained in the NFI are alpha-linolenic acid (ALA), stearidonic acid (SDA) and linoleic acid, with smaller amounts of oleic acid, gamma-linolenic acid (GLA) and saturated FAs. With the exceptions of SDA and GLA, these FAs are widely present in common foods. The NFI is intended to be used in a range of foods and food supplements to provide approximately 200 mg of SDA per day. Upon digestion, FAs are used primarily as an energy source. ALA and SDA can be elongated and desaturated to produce eicosapentaenoic acid. In human studies using various sources of SDA, no increase or small increases in SDA were observed in blood cell membranes or in total plasma. The proposed specifications for pyrrolizidine alkaloids and erucic acid, which are undesirable substances,do not give rise to concern in view of the proposed conditions of use. The available information does not give concerns as regards other undesirable substances in the NFI. Available animal studies provide only limited information on the safety of the NFI. Human studies that investigated different plant oils or fatty acid ethyl esters as sources of SDA, GLA and ALA found no adverse effects with up to 4 200 mg SDA/day for 12 weeks, up to 1 700 mg GLA/day for 28 days and 9 100 mg ALA/day for four weeks. The Panel concludes that the NFI is safe for the proposed uses and use levels.© European Food Safety Authority, 2015
Scientific Opinion on the safety of refined Buglossoides oil as a novel food ingredient
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
L-Tryptophan, technically pure, is a feed additive produced by a genetically modified Escherichia coli strain (CGMCC 7.59). The additive does not give rise to safety concerns regarding the genetic modifications of the production strain. The use of L-Tryptophan produced by E. coli CGMCC 7.59 in feed is safe for non-ruminant target species when supplemented to diets in appropriate amounts. As the metabolites of L-Tryptophan produced by ruminal bacteria may be toxic to the host animal, oral administration of unprotected L-Tryptophan to ruminants should be avoided. The Panel on Additives and Products or substances used in Animal Feed (FEEDAP) has concerns about the safety of L-Tryptophan for target species when administered via water for drinking. The composition of edible tissues and products of animal origin will not be changed by the use of the product L-Tryptophan in animal nutrition when supplemented in appropriate amounts. No risks are expected for the consumer from the use of L-Tryptophan, produced by E. coli CGMCC 7.59 as a feed additive, considering the purity of the additive (≥ 99.1 % L-Tryptophan) and the low levels of 1,1′-ethylidene-bis-L-Tryptophan (EBT) and 1-methyl-1,2,3,4-tetrahydro-beta-carboline-3-carboxylic acid (MTCA) (< 10 mg/kg additive each). The product L-Tryptophan, technically pure, is considered to be non-irritant to skin and eyes. In the absence of any data on sensitisation, the product should be considered a potential dermal sensitiser. The level of endotoxins present in the product and its dusting potential indicate a health risk for the user upon inhalation. The product under assessment does not pose any risk to the environment when supplemented to feed. The product L-Tryptophan is regarded as an effective source of the amino acid L-Tryptophan for all non-ruminant species. For the supplemental L-Tryptophan to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen.
© European Food Safety Authority, 2015
Scientific Opinion on the safety and efficacy of L-tryptophan produced by Escherichia coli CGMCC 7.59 for all animal species based on a dossier submitted by HELM AG on behalf of Meihua Holdings Co. Ltd
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