FORTINI PRO DĚTI S VLÁKNINOU - NEUTRAL

Základní informace

  • Název přípravku:
  • FORTINI PRO DĚTI S VLÁKNINOU - NEUTRAL Perorální roztok
  • Léková forma:
  • Perorální roztok
  • Podání:
  • Perorální podání
  • Jednotky v balení:
  • 1X200ML Lahev
  • Použij pro:
  • Lidé
  • Léčitelství typu:
  • alopatický drog

Dokumenty

Lokalizace

  • K dispozici v:
  • FORTINI PRO DĚTI S VLÁKNINOU - NEUTRAL Perorální roztok
    Česká republika
  • Jazyk:
  • čeština

Terapeutická informace

  • Terapeutické oblasti:
  • POTRAVINY PRO ZVLÁŠTNÍ LÉKAŘSKÉ ÚČELY (PZLÚ)
  • Přehled produktů:
  • FORTINI PRO DĚTI S VLÁKNINOU - NEUTRAL

Další informace

Stav

  • Zdroj:
  • SUKL - Státní ústav pro kontrolu léčiv
  • Poslední aktualizace:
  • 22-06-2017

Příbalovou informaci pro pacienta

Dietní potravina pro zvláštní lékařské účely

Vysokoenergetická nutričně kompletní tekutá výživa s vlákninou pro děti

od 1 roku věku. Určeno k dietnímu postupu při podvýživě související

s nemocí a poruchami růstu. Obsahuje směs šesti druhů vlákniny. Bez

lepku. Baleno v ochranné atmosféře. Ošetřeno UHT.

Důležitá upozornění: Pouze pro enterální použití. Pouze pro použití

pod lékařským dohledem. Vhodný jako jediný zdroj výživy pro děti

od 1 roku věku. Kvůli obsahu vlákniny je při užití více než 4

lahviček denně potřebná zvýšená opatrnost u mladších

dětí. Nevhodný pro pacienty s galaktosémií.

Návod k použití: Skladujte na suchém a chladném místě.

Před použitím dobře protřepejte. Určený k přímému po

užití, nejlépe chutná vychlazený. Po otevření uchovávejte

v uzavřené lahvičce v chladničce max. 24 hodin. Při podá

vání přímo z lahvičky nedopitou výživu zlikvidujte.

Dávkování: Určí lékař nebo pracovník kvalifikovaný

v oblasti výživy.

Složení: voda, maltodextrin, glukózový sirup, rostlin

né oleje (řepkový, slunečnicový), kaseinát z kravského

mléka, vláknina (sójové polysacharidy, inulin, oligofruk

tóza, rezistentní škrob, arabská guma, celulóza), emulgátor

(sójový lecitin), citronan draselný, fosforečnan vápenatý,

chlorid hořečnatý, hydrogenfosforečnan didraselný, chlorid

vápenatý, cholin chlorid, karotenoidy ((obsahuje sóju)

ß-karoten, lutein, lykopen), L-askorban sodný, chlorid draselný,

hydroxid draselný, taurin, mléčnan železnatý, síran zinečnatý,

L-karnitin, nikotinamid, glukonan měďnatý, retinyl-acetát, seleničitan

sodný, síran manganatý, cholekalciferol, D-biotin, D-pantothenát vá

penatý, DL-

-tokoferyl-acetát, thiamin hydrochlorid, chlorid chromitý,

riboflavin, pyridoxin hydrochlorid, kyselina pteroylmonoglutamová, fluorid

sodný, jodid draselný, molybdenan sodný, kyanokobalamin, fytomenadion.

Minimální trvanlivost do: viz dolní okraj lahvičky.

Výrobce: N.V. Nutricia, Zoetermeer, Nizozemí

Kontakt pro ČR: Nutricia a.s., Na Hřebenech II 1718/10,

140 00 Praha 4, infolinka: 800 110 001,

www.vyzivavnemoci.cz

FORTINI pRO děTI

s vlákNINOu, neutral

CZ/03/082014

Obsah:

200 ml

Průměrný obsah ve 100 ml:

Energetická hodnota 640 kJ (153 kcal)

Tuky (40 En%) 6,8 g

- z toho nasycené mastné kyseliny 0,7 g

Sacharidy (49 En%) 18,8 g

- z toho cukry 4,6 g - laktóza <0,025 g

Vláknina (2 En%) 1,5 g

Bílkoviny (9 En%) 3,4 g

Sůl 0,17 g

Vitaminy: vitamin A 61 μg RE; vitamin D

1,5 μg; vitamin E 1,9 mg

-TE; vitamin

K 6,0 μg; thiamin 0,23 mg; riboflavin

0,24 mg; niacin 0,88 mg (1,65 mg NE);

kyselina

pantothenová

0,50

vitamin B

0,18 mg; kyselina listová

23 μg; vitamin B

0,26 μg; biotin

6,0 μg; vitamin C 15 mg

Minerální látky a stopové prvky:

sodík 67 mg; draslík 140 mg; chloridy

100 mg; vápník 84 mg; fosfor 75 mg;

hořčík 17 mg; železo 1,5 mg; zinek 1,5 mg;

měď 0,135 mg; mangan 0,23 mg; fluor

0,11 mg; molybden 6,0 μg; selen 4,5 μg;

chrom 5,3 μg; jód 15 μg

Jiné:

karotenoidy

0,15

L-karnitin

cholin

taurin

Osmolarita

mOsmol/l

17-10-2018

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

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

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 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 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

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

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 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

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

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 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

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

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

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

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

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 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

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

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, 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. 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

3-10-2018

SÚKL informuje o přerušení či ukončení dodávek LP na český trh 17. 9. – 30. 9. 2018

SÚKL informuje o přerušení či ukončení dodávek LP na český trh 17. 9. – 30. 9. 2018

Státní ústav pro kontrolu léčiv informuje o přípravcích, u kterých držitel rozhodnutí o registraci oznámil přerušení nebo ukončení dodávek na český trh, včetně informace o nahrazujícím léčivém přípravku, pokud byl léčivý přípravek vyhodnocen jako nahraditelný.

Český Republich - SUKL - State Institute for Drug Control

1-10-2018

Public Notification: Shengan Natural Model contains hidden drug ingredient

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

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

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

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

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

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

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

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

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

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 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

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

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 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

26-9-2018

SÚKL informuje o přerušení či ukončení dodávek LP na český trh 10. 9. – 23. 9. 2018

SÚKL informuje o přerušení či ukončení dodávek LP na český trh 10. 9. – 23. 9. 2018

Státní ústav pro kontrolu léčiv informuje o přípravcích, u kterých držitel rozhodnutí o registraci oznámil přerušení nebo ukončení dodávek na český trh, včetně informace o nahrazujícím léčivém přípravku, pokud byl léčivý přípravek vyhodnocen jako nahraditelný.

Český Republich - SUKL - State Institute for Drug Control

25-9-2018

Allergy Alert Issued in Whole Foods Market Stores Nationwide for Undeclared Milk in 365 Everyday Value White Corn Tortilla Chips

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

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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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

25-9-2018

Fycompa (Eisai GmbH)

Fycompa (Eisai GmbH)

Fycompa (Active substance: Perampanel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6280 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002434/T/0040

Europe -DG Health and Food Safety

25-9-2018

Opsumit (Janssen-Cilag International NV)

Opsumit (Janssen-Cilag International NV)

Opsumit (Active substance: macitentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6279 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002697/T/0028

Europe -DG Health and Food Safety

25-9-2018

Imfinzi (AstraZeneca AB)

Imfinzi (AstraZeneca AB)

Imfinzi (Active substance: durvalumab) - Centralised - Authorisation - Commission Decision (2018)6289 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004771/0000

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety