LACTADES PRO
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- LACTADES PRO
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- ECOLAB DEUTSCHLAND GMBH
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- Хората
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- Медицински устройство
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България
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Друга информация
Състояние
- Източник:
- Ecolab
- Номер на разрешението:
- 115829E
- Последна актуализация:
- 12-03-2018
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18-10-2018
Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19
Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...
Europe - EFSA - European Food Safety Authority Publications
18-10-2018
Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment
Published on: Wed, 17 Oct 2018 00:00:00 +0200 The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. Th...
Europe - EFSA - European Food Safety Authority Publications
18-10-2018
P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins
P. EAST TRADING CORP. of Bronx, NY is recalling Fruits Du Sud Golden Seedless Raisins (Lot No. FDS T499/18) 30 lbs Box, because they contain undeclared SULFITES. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products.
FDA - U.S. Food and Drug Administration
17-10-2018
SLR Food Distribution Inc. Issues Alert on Undeclared Sulfites in Sugar Melon Candy
SLR Food Distribution Inc. of New Hyde Park, NY is recalling its 7.04oz package of SUGAR MELON CANDY / WAX GOURD because it contains undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.
FDA - U.S. Food and Drug Administration
17-10-2018
New Nan Fong Hong Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Source Day Natural Treasures Dried Liquorice Slice
New Nan Fong Hong Trading Inc. is recalling its 16 oz (454g) packages of Source Day Natural Treasures Dried Liquorice Slice because they contain undeclared sulfites. Consumers who are allergic to sulfite allergens run the risk of serious or life-threatening allergic reactions if they consume this product.
FDA - U.S. Food and Drug Administration
17-10-2018
Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)
Faribault Foods, Inc. of Faribault, MN is recalling its 15 ounce S&W White Beans because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.
FDA - U.S. Food and Drug Administration
17-10-2018
Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens
Clackamas Bakery has recalled Fred Meyer Bakery Angel Food Cake Bar (12 oz.) sold in its retail stores because the product may contain milk and soy not listed on the label. Clackamas Bakery initiated the recall when it was discovered that the Fred Meyer Bakery Angel Food Cake Bar label had been incorrectly applied to packages of cornbread.
FDA - U.S. Food and Drug Administration
16-10-2018
Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron
Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...
Europe - EFSA - European Food Safety Authority Publications
16-10-2018
Feel Good Foods Inc Issues Allergy Alert on Undeclared Egg Product In “Vegetable Fried Rice”
Feel Good Foods Inc. of Brooklyn, NY is recalling six lots of “Vegetable Fried Rice” frozen meals, UPC 00899039002129 because they may contain undeclared egg. People who have allergies to egg run the risk of serious or life-threatening allergic reaction if they consume these products.
FDA - U.S. Food and Drug Administration
15-10-2018
Apollo Food International Inc Issues Allergy Alert on Undeclared Eggs In “Mini Roll”
Apollo Food International Inc. of Long Island City, NY, is recalling its 2.469 ounce packages of “Mini Roll” food treats because they may contain undeclared eggs. Consumers who are allergic to eggs may run the risk of serious or life-threatening allergic reactions if they consume this product.
FDA - U.S. Food and Drug Administration
15-10-2018
Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies
FDA issues two guidance documents to provide drug developers greater clarity and direction as they pursue the next generation of therapies and treatments for patients.
FDA - U.S. Food and Drug Administration
15-10-2018
Toy Land Company recalls Boom Boom ChemsSlime andPutty
Health Canada has determined that the slime and putty products do not meet the Canadian toy safety requirements related to boric acid content.
Health Canada
12-10-2018
FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy
FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy
FDA - U.S. Food and Drug Administration
12-10-2018
Voluntary Recall of Limited Amounts of Nuts & Vanilla Protein Plant Shake
Forager Project is recalling three dates of Nuts and Vanilla – Organic Plant Protein Shake because the product contains almond flour which is not declared on the label.
FDA - U.S. Food and Drug Administration
11-10-2018
Cooper Lighting LLC Recalls All-Pro and Defiant Solar/Battery Powered Light Fixtures
The batteries in the solar-powered light fixtures can overheat and cause the light fixture's housing to melt, posing a fire hazard.
Health Canada
10-10-2018
Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.
Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. Liveyon marketed and distributed these products under the trade name ReGen Series®. Liveyon has voluntarily recalled all ReGen Series® products due to reported possible adverse reactions.
FDA - U.S. Food and Drug Administration
10-10-2018
Voluntary Recall Issued for Sweet Me Creamery Brookie Dough Ice Cream that may Contain an Undeclared Peanut Allergen
Kemps of St. Paul, Minn., is voluntarily recalling Sweet Me Creamery Brookie Dough ice cream, individual pints and pint four-packs, because it may contain an undeclared peanut allergen. Individuals who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume these products.
FDA - U.S. Food and Drug Administration
10-10-2018
Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination
Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.
FDA - U.S. Food and Drug Administration
10-10-2018
Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk
BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE IMPACTED OR PART OF THIS RECALL. The recall is being initiated voluntarily and no illnesses have been reported to date.
FDA - U.S. Food and Drug Administration
9-10-2018
Ukrop’s Homestyle Foods, LLC Announces Recalls Because of Possible Health Risk
Johnston County Hams’ country ham was recalled due to its potential for contamination with Listeria monocytogenes; therefore, Ukrop’s made the decision that any products that contained country ham or came into contact with equipment used to process the country ham are being recalled due to the potential to be contaminated with Listeria monocytogenes.
FDA - U.S. Food and Drug Administration
9-10-2018
Essity Professional Hygiene North America LLC recalls Tork Foam Soap Extra Mild SKU
The recalled product is potentially contaminated with the bacteria Burkholderia cepacia. B. cepacia is found in soil and water and poses little medical risk to healthy people.
Health Canada
6-10-2018
Ladyfingers Gourmet to Go Voluntarily Recalls Signature Shaved Country Ham Rolls Due to Possible Health Risk
Ladyfingers Caterers is voluntarily recalling its Signature Shaved Country Ham Rolls as a result of the Johnston County Hams recall. The rolls were made with ham produced by Johnston County Hams, which recently initiated a recall of its ham products due to possible contamination with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer onl...
FDA - U.S. Food and Drug Administration
5-10-2018
Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled
Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...
FDA - U.S. Food and Drug Administration
5-10-2018
Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams
Johnston County Hams, Inc. issued a voluntary recall on October 3, 2018 for approximately 89,096 pounds of ready-to-eat ham products due to possible contamination with Listeria monocytogenes. In response, Callie's Charleston Biscuits, LLC is issuing a voluntary product recall for two products that may contain the potentially affected Johnston County Hams.
FDA - U.S. Food and Drug Administration
5-10-2018
Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk
Working Cow Homemade Ice Cream, Inc. of St. Petersburg, FL is conducting a voluntary recall of No Sugar Added Vanilla and No Sugar Added Chocolate ice cream manufactured in three-gallon tubs during the month of May 2018. The recall is being conducted due to a potential contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only...
FDA - U.S. Food and Drug Administration
4-10-2018
Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination
Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.
FDA - U.S. Food and Drug Administration
1-10-2018
Public Notification: Shengan Natural Model contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Shengan Natural Model, a product promoted for weight loss. This product was identified during an examination of international mail shipments.
FDA - U.S. Food and Drug Administration
1-10-2018
Public Notification: USA for Women contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use USA for Women, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.
FDA - U.S. Food and Drug Administration
1-10-2018
Public Notification: In Shape contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use In Shape, a product promoted for weight loss. This product was identified during an examination of international mail shipments.
FDA - U.S. Food and Drug Administration
1-10-2018
Public Notification: ProSolution contains hidden drug ingredient
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Pro Solution, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.
FDA - U.S. Food and Drug Administration
1-10-2018
Public Notification: FX75000 contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use FX75000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.
FDA - U.S. Food and Drug Administration
1-10-2018
Public Notification: Baschi Quick Slimming Capsule contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Baschi Quick Slimming Capsule, a product promoted for weight loss. This product was identified during an examination of international mail shipments.
FDA - U.S. Food and Drug Administration
1-10-2018
Public Notification: V-Max contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use V-Max, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.
FDA - U.S. Food and Drug Administration
1-10-2018
Public Notification: Strong Horses contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Strong Horses, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.
FDA - U.S. Food and Drug Administration
1-10-2018
Public Notification: Green Lean Body Capsule contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Green Lean Body Capsule, a product promoted for weight loss. This product was identified during an examination of international mail shipments.
FDA - U.S. Food and Drug Administration
1-10-2018
Public Notification: Like Slim Coffee contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Like Slim Coffee, a product promoted for weight loss. This product was identified during an examination of international mail shipments.
FDA - U.S. Food and Drug Administration
28-9-2018
Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label
Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...
FDA - U.S. Food and Drug Administration
28-9-2018
Drug agency from China visits Denmark
A delegation from the Centre for Drug Evaluation under the China National Medical Products Administration visited the Danish Medicines Agency this week to discuss clinical trials and drug monitoring, among other things. The meeting at the Danish Medicines Agency is part of a Danish-Chinese collaboration under the auspices of the China-Denmark Food and Drug Regulatory Cooperation Centre, which was established with the signing of a collaboration agreement in May of last year, and which aims to strengthen r...
Danish Medicines Agency
27-9-2018
General Finishes Recalls Outdoor Oil
The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.
Health Canada
27-9-2018
Mauna Loa Macadamia Nut Corporation Voluntarily Recalls
Mauna Loa Macadamia Nut Corporation is voluntarily recalling all of its products produced at the Keaau facility between Sept. 6 - 21, 2018 due to a potential contamination of Escherichia coli (E. coli). The recall was initiated due to E. coli being detected in the well water and distribution system that supplies the firm's operations. No illnesses related to the water have been reported to the state.
FDA - U.S. Food and Drug Administration
25-9-2018
Allergy Alert Issued in Whole Foods Market Stores Nationwide for Undeclared Milk in 365 Everyday Value White Corn Tortilla Chips
Whole Foods Market is voluntarily recalling 365 Everyday Value White Corn Tortilla Chips because the product may contain undeclared milk that was not listed on the product label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product
FDA - U.S. Food and Drug Administration
25-9-2018
Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product
Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.
FDA - U.S. Food and Drug Administration
2-10-2018
Zavesca (Janssen-Cilag International NV)
Zavesca (Active substance: Miglustat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5472 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000435/T/0063
Europe -DG Health and Food Safety
2-10-2018
Dynastat (Pfizer Europe MA EEIG)
Dynastat (Active substance: Parecoxib ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6471 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000381/T/0073
Europe -DG Health and Food Safety
2-10-2018
Retacrit (Pfizer Europe MA EEIG)
Retacrit (Active substance: epoetin zeta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6481 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/872/T/86
Europe -DG Health and Food Safety
2-10-2018
HALAVEN (Eisai GmbH)
HALAVEN (Active substance: eribulin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6457 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2084/T/46
Europe -DG Health and Food Safety
2-10-2018
Imraldi (Samsung Bioepis UK Limited)
Imraldi (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)6458 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/IB/14
Europe -DG Health and Food Safety
2-10-2018
Nexium Control (Pfizer Healthcare Ireland)
Nexium Control (Active substance: esomeprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6474 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002618/T/0023
Europe -DG Health and Food Safety
1-10-2018
MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)
MS-H vaccine (Active substance: Mycoplasma synoviae Strain MS-H live attenuated thermosensitive) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6404 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/161/T/11
Europe -DG Health and Food Safety
1-10-2018
Verzenios (Eli Lilly Nederland B.V.)
Verzenios (Active substance: abemaciclib) - Centralised - Authorisation - Commission Decision (2018)6405 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4302
Europe -DG Health and Food Safety
1-10-2018
EU/3/16/1762 (Pharma Gateway AB)
EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01
Europe -DG Health and Food Safety
1-10-2018
EU/3/05/328 (Celgene Europe B.V.)
EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03
Europe -DG Health and Food Safety
1-10-2018
EU/3/05/279 (Celgene Europe B.V.)
EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03
Europe -DG Health and Food Safety
1-10-2018
EU/3/03/133 (Shire Orphan Therapies GmbH)
EU/3/03/133 (Active substance: Icatibant acetate) - Transfer of orphan designation - Commission Decision (2018)6432 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/054/02/T/01
Europe -DG Health and Food Safety
1-10-2018
Gefitinib Mylan (Mylan S.A.S.)
Gefitinib Mylan (Active substance: gefitinib) - Centralised - Authorisation - Commission Decision (2018)6406 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4826
Europe -DG Health and Food Safety
30-9-2018
Roteas (Daiichi Sankyo Europe GmbH)
Roteas (Active substance: edoxaban) - PSUSA - Modification - Commission Decision (2018)5089 of Sun, 30 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10387/201710
Europe -DG Health and Food Safety
26-9-2018
FORTEKOR PLUS (Elanco GmbH)
FORTEKOR PLUS (Active substance: pimobendan / benazepril) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6321 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2804/T/11
Europe -DG Health and Food Safety
26-9-2018
Comfortis (Elanco GmbH)
Comfortis (Active substance: Spinosad) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6323 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2233/T/18
Europe -DG Health and Food Safety
26-9-2018
Kexxtone (Elanco GmbH)
Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10
Europe -DG Health and Food Safety
25-9-2018
Udenyca (ERA Consulting GmbH)
Udenyca (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6290 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004413/0000
Europe -DG Health and Food Safety
25-9-2018
Inovelon (Eisai GmbH)
Inovelon (Active substance: Rufinamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6283 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/660/T/48
Europe -DG Health and Food Safety
25-9-2018
Zonegran (Eisai GmbH)
Zonegran (Active substance: zonisamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6285 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/577/T/90
Europe -DG Health and Food Safety
25-9-2018
Slenyto (RAD Neurim Pharmaceuticals EEC Limited)
Slenyto (Active substance: melatonin) - Centralised - Authorisation - Commission Decision (2018)6223 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425
Europe -DG Health and Food Safety
25-9-2018
Brilique (AstraZeneca AB)
Brilique (Active substance: ticagrelor) - PSUSA - Modification - Commission Decision (2018)6282 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1241/PSUSA/2948/201712
Europe -DG Health and Food Safety