Latanoprost Unimed Pharma

Glavne informacije

  • Zaščiteno ime:
  • Latanoprost Unimed Pharma 50 mikrogramov/ml kapljice za oko, raztopina
  • Farmacevtska oblika:
  • kapljice za oko, raztopina
  • Sestava:
  • latanoprost 50 µg / 1 ml
  • Pot uporabe:
  • Nazalna uporaba
  • Enote v paketu:
  • škatla z 1 plastenko s kapalnikom z 2,5 ml raztopine
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Latanoprost Unimed Pharma 50 mikrogramov/ml kapljice za oko, raztopina
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • latanoprost

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z dovoljenjem za promet
  • Številka dovoljenja:
  • 1011-128/213-8
  • Datum dovoljenje:
  • 23-07-2015
  • EAN koda:
  • 3837000141054
  • Zadnja posodobitev:
  • 19-01-2018

Podatki za bolnike

NAVODILO ZA UPORABO

JAZMP – R/001 – 26.11.2014

Navodilo za uporabo

Latanoprost Unimed Pharma 50 mikrogramov/ml kapljice za oko, raztopina

latanoprost

Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!

Navodilo shranite. Morda ga boste želeli ponovno prebrati.

Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.

Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim. Njim bi lahko celo škodovalo,

čeprav imajo znake bolezni, podobne vašim.

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom. Posvetujte se tudi,

če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu. Glejte poglavje 4.

Kaj vsebuje navodilo

Kaj je zdravilo Latanoprost Unimed Pharma in za kaj ga uporabljamo

Kaj morate vedeti, preden boste uporabili zdravilo Latanoprost Unimed Pharma

Kako uporabljati zdravilo Latanoprost Unimed Pharma

Možni neželeni učinki

Shranjevanje zdravila Latanoprost Unimed Pharma

Vsebina pakiranja in dodatne informacije

1. Kaj je zdravilo Latanoprost Unimed Pharma in za kaj ga uporabljamo

Zdravilo Latanoprost Unimed Pharma sodi v skupino zdravil, ki jih imenujemo analogi prostaglandina.

Zdravilo Latanoprost Unimed Pharma povečuje naravno odtekanje tekočine iz očesa v krvni obtok.

Zdravilo Latanoprost Unimed Pharma uporabljamo za zdravljenje obolenja, imenovanega

glavkom z

odprtim zakotjem

, in motnje, imenovane

očesna hipertenzija

. Obe motnji sta povezani z zvišanim tlakom

v očesu in lahko sčasoma prizadeneta vid.

Zdravilo Latanoprost Unimed Pharma se uporablja tudi za zdravljenje povišanega očesnega tlaka in

glavkoma pri otrocih vseh starosti in pri dojenčkih.

2. Kaj morate vedeti, preden boste uporabili zdravilo Latanoprost Unimed Pharma

Zdravilo Latanoprost Unimed Pharma se lahko uporablja pri odraslih moških in ženskah (vključno s

starostniki) kot tudi pri otrocih od rojstva do 18. leta starosti. Zdravilo Latanoprost Unimed Pharma ni bilo

raziskano pri nedonošenih dojenčkih (rojenih pred 36. tednom nosečnosti).

Ne uporabljajte zdravila Latanoprost Unimed Pharma:

če ste alergični na latanoprost ali katero koli sestavino tega zdravila (navedeno v poglavju 6).

če ste noseči ali če načrtujete nosečnost

če dojite

Opozorila in previdnostni ukrepi

Pred začetkom uporabe zdravila Latanoprost Unimed Pharma se posvetujte s svojim zdravnikom ali z

zdravnikom, ki zdravi vašega otroka ali farmacevtom, če menite, da kaj od navedenega velja za vas ali

vašega otroka:

JAZMP – R/001 – 26.11.2014

če boste imeli vi ali vaš otrok operacijo na očeh ali ste jo prestali (vključno z operacijo sive mrene),

če imate vi ali vaš otrok težave z očmi (kot so bolečina, draženje ali vnetje, zamegljen vid),

če imate vi ali vaš otrok težave zaradi suhih oči,

če imate vi ali vaš otrok hudo obliko astme ali če le-ta ni uravnana z zdravili,

če nosite vi ali vaš otrok kontaktne leče. Zdravilo Latanoprost Unimed Pharma lahko še vedno

uporabljate, vendar sledite navodilom za uporabnike kontaktnih leč v poglavju 3,

če ste kdaj imeli ali trenutno imate virusno okužbo očesa, ki jo povzroča virus herpes simpleks (HSV).

Druga zdravila in zdravilo Latanoprost Unimed Pharma

Zdravilo Latanoprost Unimed Pharma lahko medsebojno deluje z drugimi zdravili. Obvestite svojega

zdravnika, zdravnika, ki zdravi vašega otroka ali farmacevta, če vi ali vaš otrok jemljete, ste pred kratkim

jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili (ali kapljicami za oči),

ki so na voljo brez recepta.

Zdravilo Latanoprost Unimed Pharma skupaj s hrano in pijačo

Ker je zdravilo raztopina za oči, njegova uporaba ni odvisna od hrane ali pijače.

Nosečnost in dojenje

Zdravila Latanoprost Unimed Pharma med nosečnostjo

ne smete uporabljati

Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom

ali farmacevtom, preden vzamete to zdravilo.

Zdravila Latanoprost Unimed Pharma med dojenjem

ne smete uporabljati

Vpliv na sposobnost upravljanja vozil in strojev

Pri uporabi zdravila Latanoprost Unimed Pharma se lahko po vkapanju za kratek čas pojavi zamegljen vid.

Če se vam to zgodi,

z upravljanjem vozil

ali strojev počakajte, dokler se vam vid ne zbistri.

Zdravilo Latanoprost Unimed Pharma vsebuje benzalkonijev klorid

Zdravilo Latanoprost Unimed Pharma vsebuje konzervans benzalkonijev klorid. Ta konzervans lahko

povzroči draženje oči in motnje na površini očesa. Benzalkonijev klorid se lahko absorbira na kontaktnih

lečah in lahko razbarva mehke kontaktne leče. Zato se izogibajte stiku z mehkimi kontaktnimi lečami.

Če vi ali vaš otrok nosite kontaktne leče, jih morate pred uporabo zdravila Latanoprost Unimed Pharma

odstraniti. Po uporabi zdravila Latanoprost Unimed Pharma počakajte najmanj 15 minut, preden zopet

vstavite kontaktne leče. Glejte navodilo za uporabnike kontaktnih leč v poglavju 3.

3. Kako uporabljati zdravilo Latanoprost Unimed Pharma

Pri uporabi tega zdravila natančno upoštevajte navodila svojega zdravnika ali zdravnika, ki zdravi vašega

otroka. Če ste negotovi, se posvetujte s svojim zdravnikom, z zdravnikom, ki zdravi vašega otroka

ali s

farmacevtom.

Priporočeni odmerek je:

Običajni odmerek za odrasle (vključno s starejšimi) in otroke

je ena kapljica enkrat na dan v obolelo oko

(oboleli očesi). Najbolj primeren čas za vkapavanje je zvečer.

Ne uporabljajte zdravila Latanoprost Unimed Pharma več kot enkrat na dan, ker se lahko pri pogostejši

uporabi zmanjša učinkovitost zdravljenja.

JAZMP – R/001 – 26.11.2014

Zdravilo Latanoprost Unimed Pharma uporabljajte po navodilu svojega zdravnika ali zdravnika, ki zdravi

vašega otroka, dokler vam ne naročijo, da nehajte.

Uporabniki kontaktnih leč

Če vi ali vaš otrok nosite kontaktne leče, jih morate pred uporabo zdravila Latanoprost Unimed Pharma

odstraniti. Po uporabi zdravila Latanoprost Unimed Pharma počakajte najmanj 15 minut, preden zopet

vstavite kontaktne leče v oči.

Navodilo za uporabo

Umijte si roke in se udobno namestite.

Odvijte pokrovček plastenke.

Plastenko obrnite navzdol in jo držite s palcem in drugimi prsti.

S prstom nežno potegnite navzdol spodnjo veko prizadetega očesa.

Konico plastenke približajte očesu, ne da bi se dotaknili očesa ali sosednjih predelov očesa.

Nežno stisnite plastenko, da v oko kanete eno kapljico in nato spustite spodnjo očesno veko.

S prstom pritisnite na notranji očesni kot ob nosu. Držite 1 minuto in oko imejte pri tem zaprto.

JAZMP – R/001 – 26.11.2014

Če vam je zdravnik naročil, postopek ponovite še v drugo oko.

Plastenko takoj po uporabi tesno zaprite s pokrovčkom.

Če uporabljate zdravilo Latanoprost Unimed Pharma z drugimi kapljicami za oči.

Počakajte vsaj 5 minut med uporabo zdravila Latanoprost Unimed Pharma in drugih kapljic za oči.

Če ste uporabili večji odmerek zdravila Latanoprost Unimed Pharma, kot bi smeli

Če boste kanili preveč kapljic v oko, lahko pride do rahlega draženja očesa, oči se lahko solzijo in postanejo

rdeče. To bo minilo, če pa ste zaskrbljeni, za nasvet vprašajte svojega zdravnika ali zdravnika, ki zdravi

vašega otroka.

Če ste vi ali vaš otrok pomotoma zaužili zdravilo Latanoprost Unimed Pharma, takoj obvestite svojega

zdravnika.

Če ste pozabili uporabiti zdravilo Latanoprost Unimed Pharma

Nadaljujte z uporabo zdravila ob običajnem času. Ne vzemite dvojnega odmerka, če ste pozabili vzeti

prejšnji odmerek.

Če ste negotovi glede česa, se posvetujte z zdravnikom ali farmacevtom.

Če ste prenehali uporabljati zdravilo Latanoprost Unimed Pharma

Ne prenehajte z uporabo zdravila Latanoprost Unimed Pharma, razen če vam tako svetuje vaš zdravnik.

Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom, z zdravnikom, ki zdravi

vašega otroka ali s farmacevtom.

4. Možni neželeni učinki

Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.

Znani so sledeči neželeni učinki uporabe zdravila Latanoprost Unimed Pharma:

Zelo pogosti (

pojavijo se lahko pri več kot 1 od 10 bolnikov)

:

Postopna sprememba barve vašega očesa zaradi večje količine rjavega pigmenta v obarvanem delu

očesa, imenovanem šarenica. Če imate oči mešane barve (modro-rjave, sivo-rjave, rumeno-rjave ali

zeleno-rjave), je večja verjetnost, da bo prišlo do te spremembe, kot če imate enotno barvo oči

(modre, sive, zelene ali rjave). Vsaka sprememba barve vaših oči lahko nastaja leta, čeprav se

največkrat razvije v 8 mesecih zdravljenja. Sprememba barve oči je lahko stalna in je lahko bolj

opazna, če uporabljate zdravilo Latanoprost Unimed Pharma le na enem očesu. Kot kaže, sprememba

barve oči ni povezana z dodatnimi težavami. Barva oči se po prenehanju uporabe zdravila

Latanoprost Unimed Pharma ne spreminja več.

Rdeče oči.

JAZMP – R/001 – 26.11.2014

Draženje oči (pekoč praskajoč občutek, srbenje, zbadanje in občutek tujka v očesu).

Postopne spremembe trepalnic na zdravljenem očesu in puhastih dlačic v okolici očesa, kar so

večinoma opažali pri bolnikih iz japonske populacije. Te spremembe vključujejo potemnitev,

podaljšanje, zadebelitev in zvečanje števila trepalnic.

Pogosti (

pojavijo se lahko pri največ 1 od 10 bolnikov)

:

Draženje ali poškodbe površine očesa, vnetje veke (blefaritis), bolečine v očeh in občutljivost na

svetlobo (fotofobija).

Občasni (

pojavijo se lahko pri največ 1 od 100 bolnikov)

:

Oteklost vek, suho oko, vnetje ali draženje površine očesa (keratitis), zamegljen vid in vnetje očesne

veznice (konjunktivitis).

Kožni izpuščaj.

Redki (

pojavijo se lahko pri največ 1 od 1.000 bolnikov)

:

Vnetje šarenice, obarvanega dela očesa (iritis/uveitis); otekanje retine (makularni edem), znaki

otekanja ali poškodbe površine očesa, otekanje okolice očesa (periorbitalni edem), napačno usmerjene

trepalnice ali pojav trepalnic v dveh vrstah.

Kožne reakcije na veki, potemnitev kože na vekah.

Astma, poslabšanje astme in težko dihanje (dispneja).

Zelo redki (

pojavijo se lahko pri največ 1 od 10.000 bolnikov)

:

Poslabšanje angine pektoris pri bolnikih z že obstoječo boleznijo srca, olečine v prsnem košu,

spremembe veke (poglobitev sulkusa očesne veke).

Bolniki so poročali tudi o naslednjih neželenih učinkih: s tekočino napolnjen mehurček v obarvanem delu

očesa (cista šarenice), glavobol, omotica, občutek razbijanja srca (palpitacije), bolečine v mišicah, bolečine

v sklepih ter pojav virusne okužbe očesa, ki jo povzroča virus herpes simpleks (HSV).

V zelo redkih primerih so se nekaterim bolnikom s hudo okvarjeno prozorno plastjo na sprednji strani očesa

(roženico) med zdravljenjem pojavile motne pege na roženici zaradi kopičenja kalcija.

Dodatni neželeni učinki pri otrocih

Neželeni učinki, opaženi pogosteje pri otrocih v primerjavi z odraslimi, so: izcedek iz nosu in srbeč nos ter

povišana telesna temperatura.

Poročanje o neželenih učinkih

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom. Posvetujte se tudi, če

opazite neželene učinke, ki niso navedeni v tem navodilu. O neželenih učinkih lahko poročate tudi

neposredno na

Univerzitetni klinični center Ljubljana, Interna klinika

Center za zastrupitve

Zaloška cesta 2

SI-1000 Ljubljana

Faks: + 386 (0)1 434 76 46

JAZMP – R/001 – 26.11.2014

e-pošta: farmakovigilanca@kclj.si

S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega

zdravila.

5. Shranjevanje zdravila Latanoprost Unimed Pharma

Zdravilo shranjujte nedosegljivo otrokom!

Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg

oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.

Originalno zaprta plastenka (pred prvim odprtjem): Shranjujte v hladilniku (2ºC - 8ºC). Ne zamrzujte.

Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.

Po prvem odprtju plastenke: Shranjujte pri temperaturi do 25ºC.

Uporabite v 28 dneh po prvem odprtju plastenke.

Ko zdravila Latanoprost Unimed Pharma ne uporabljate, shranjujte plastenko v škatli za zagotovitev zaščite

pred svetlobo.

Ne uporabljajte tega zdravila, če opazite vidne poškodbe zdravila ali poškodbo varnostnega traku pri prvem

odpiranju plastenke. V takem primeru vrnite zdravilo v lekarno.

Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke. O načinu odstranjevanja zdravila,

ki ga ne uporabljate več, se posvetujte s farmacevtom. Takšni ukrepi pomagajo varovati okolje.

6. Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Latanoprost Unimed Pharma

Zdravilna učinkovina je latanoprost. 1 ml raztopine kapljic za oko vsebuje 50 mikrogramov

latanoprosta.

Druge sestavine zdravila so natrijev klorid, raztopina benzalkonijevega klorida, natrijev

dihidrogenfosfat monohidrat (E339a), brezvodni natrijev hidrogenfosfat (E339a), klorovodikova

kislina za uravnavanje pH, natrijev hidroksid za uravnavanje pH, voda za injekcije.

Izgled zdravila Latanoprost Unimed Pharma in vsebina pakiranja

Latanoprost Unimed Pharma kapljice za oko so bistra, brezbarvna raztopina, skoraj brez delcev.

Vsaka plastenka zdravila Latanoprost Unimed Pharma vsebuje 2,5 ml raztopine kapljic za oko.

Zdravilo je na voljo v naslednjih pakiranjih: 1 x 2,5 ml, 3 x 2,5 ml (polietilenska plastenka s kapalnikom za

oči).

Na trgu morda ni vseh pakiranj.

Način izdaje zdravila Latanoprost Unimed Pharma

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

UNIMED PHARMA, spol. s r.o. Oriešková 11, 821 05, Bratislava, Slovaška

JAZMP – R/001 – 26.11.2014

Tel.: +421 2 4333 3786

Fax: +421 2 4363 8743

e-mail: unimedpharma@unimedpharma.sk

www.unimedpharma.eu

Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:

Bolgarija

УНИЛАТ 50 микрограма/ml kапки за очи, разтвор

Češka

UNILAT 50 mikrogramů/ml oční kapky, roztok

Estonija

UNILAT 50 mikrogrammi/ml silmatilgad, lahus

Latvija

UNILAT 50 mikrogrami/ml acu pilieni, šķīdums

Litva

UNILAT 50 mikrogramų/ml akių lašai, tirpalas

Romunija

UNILAT 50 micrograme/ml picături oftalmice, soluţie

Slovaška

UNILAT 50 mikrogramov/ml očná roztoková instilácia

Avstrija

Latanoprost Unimed Pharma 50 Mikrogramm/ml Augentropfen

Nemčija

Latanoprost Unimed Pharma 50 Mikrogramm/ ml Augentropfen

Madžarska

Unilat 0,05 mg/ml oldatos szemcsepp

Slovenija

Latanoprost Unimed Pharma 50 mikrogramov/ml kapljice za oko, raztopina

Navodilo je bilo nazadnje revidirano dne 26.11.2014

JAZMP – R/001 – 26.11.2014

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Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials, to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution.

FDA - U.S. Food and Drug Administration

28-9-2018

Debate on research dissemination at the Danish Medicines Agency

Debate on research dissemination at the Danish Medicines Agency

On 1 October, the Danish Medicines Agency and the Danish Society for Pharmacoepidemiology have invited a number of researchers, doctors and communication officers from research institutions throughout Denmark to a debate on how the findings of new health research can be disseminated most responsibly. The debate meeting can be followed live on the Danish Medicines Agency’s Facebook profile.

Danish Medicines Agency

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

28-8-2018

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.

Danish Medicines Agency

20-8-2018

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

FDA - U.S. Food and Drug Administration

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

28-7-2018

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

13-7-2018

Scientific guideline:  Guideline on good pharmacogenomic practice - First version, adopted

Scientific guideline: Guideline on good pharmacogenomic practice - First version, adopted

This guideline provides recommendations for the conduct of genomic studies in relation to medical therapy in order to provide high quality information on the impact of genomic variability on drug response. Primary focus is on the analysis of genomic germline DNA. The analysis of somatic DNA and genomic biomarkers for cancer treatment is not being discussed and might be developed as an Annex or in separate guidance.

Europe - EFSA - European Food Safety Authority EFSA Journal

11-7-2018

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

FDA - U.S. Food and Drug Administration

11-7-2018

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

FDA - U.S. Food and Drug Administration

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

1-11-2018

Protopic (Leo Pharma A/S)

Protopic (Leo Pharma A/S)

Protopic (Active substance: Tacrolimus) - Centralised - Yearly update - Commission Decision (2018)7343 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

29-10-2018

Sustiva (Bristol-Myers Squibb Pharma EEIG)

Sustiva (Bristol-Myers Squibb Pharma EEIG)

Sustiva (Active substance: efavirenz) - Centralised - 2-Monthly update - Commission Decision (2018)7252 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/249/II/145/G

Europe -DG Health and Food Safety

25-10-2018

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Active substance: enzalutamide) - Centralised - 2-Monthly update - Commission Decision (2018)7132 of Thu, 25 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2639/II/39G

Europe -DG Health and Food Safety

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

16-10-2018

Dexxience (Portola Pharma UK Limited)

Dexxience (Portola Pharma UK Limited)

Dexxience (Active substance: betrixaban) - Refusal of authorisation - Commission Decision (2018)6226 of Tue, 16 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4309

Europe -DG Health and Food Safety

2-10-2018

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Active substance: Lamivudine) - Centralised - Yearly update - Commission Decision (2018)6476 of Tue, 02 Oct 2018

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

24-9-2018

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Active substance: Botulinum Toxin Type B) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6221 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000301/T/0101

Europe -DG Health and Food Safety

24-9-2018

Rasilez (Noden Pharma DAC)

Rasilez (Noden Pharma DAC)

Rasilez (Active substance: aliskiren) - Centralised - Yearly update - Commission Decision (2018)6229 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (Active substance: vigabatrin) - Centralised - Authorisation - Commission Decision (2018)6224 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4534

Europe -DG Health and Food Safety

24-9-2018

INCRELEX (Ipsen Pharma)

INCRELEX (Ipsen Pharma)

INCRELEX (Active substance: Mecasermin) - Centralised - Yearly update - Commission Decision (2018)6240 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 6097 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3962/T/08

Europe -DG Health and Food Safety

19-9-2018

Agenda:  Agenda – 12th Pharmacovigilance stakeholder forum

Agenda: Agenda – 12th Pharmacovigilance stakeholder forum

Europe - EMA - European Medicines Agency

19-9-2018

 12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety

29-8-2018

Cometriq (Ipsen Pharma)

Cometriq (Ipsen Pharma)

Cometriq (Active substance: cabozantinib) - PSUSA - Modification - Commission Decision (2018)5761 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10180/201711

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

27-8-2018

Yescarta (Kite Pharma EU B.V.)

Yescarta (Kite Pharma EU B.V.)

Yescarta (Active substance: axicabtagene ciloleucel) - Centralised - Authorisation - Commission Decision (2018)5718 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4480

Europe -DG Health and Food Safety

27-8-2018

Entyvio (Takeda Pharma A/S)

Entyvio (Takeda Pharma A/S)

Entyvio (Active substance: vedolizumab) - PSUSA - Modification - Commission Decision (2018)5712 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10186/201711

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

17-8-2018

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Active substance: Thymidine and deoxycytidine) - Transfer of orphan designation - Commission Decision (2018)5403 of Fri, 17 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/317/16/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Active substance: Recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1) - Orphan designation - Commission Decision (2018)5281 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/053/18

Europe -DG Health and Food Safety

6-8-2018

Kyntheum (Leo Pharma A/S)

Kyntheum (Leo Pharma A/S)

Kyntheum (Active substance: brodalumab) - Centralised - Yearly update - Commission Decision (2018)5383 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Active substance: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene) - Orphan designation - Commission Decision (2018)5280 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/061/18

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Active substance: nivolumab) - Centralised - 2-Monthly update - Commission Decision (2018)5204 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3985/II/41

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Active substance: fidaxomicin) - Centralised - Yearly update - Commission Decision (2018)4889 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (Active substance: dinutuximab beta) - Centralised - Yearly update - Commission Decision (2018)4886 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

19-7-2018

Aplidin (Pharma Mar S.A.)

Aplidin (Pharma Mar S.A.)

Aplidin (Active substance: plitidepsin) - Refusal of authorisation - Commission Decision (2018)4831 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4354

Europe -DG Health and Food Safety

13-7-2018

Briviact (UCB Pharma S.A.)

Briviact (UCB Pharma S.A.)

Briviact (Active substance: brivaracetam) - Centralised - 2-Monthly update - Commission Decision (2018)4715 of Fri, 13 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3898/II/10/G

Europe -DG Health and Food Safety

10-7-2018

Ninlaro (Takeda Pharma A/S)

Ninlaro (Takeda Pharma A/S)

Ninlaro (Active substance: ixazomib) - Centralised - Yearly update - Commission Decision (2018)4463 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

4-7-2018

Prialt (RIEMSER Pharma GmbH)

Prialt (RIEMSER Pharma GmbH)

Prialt (Active substance: ziconotide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4334 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/551/T/56

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2036 (PharmaKrysto Ltd)

EU/3/18/2036 (PharmaKrysto Ltd)

EU/3/18/2036 (Active substance: L-cystine bis(N'-methylpiperazide)) - Orphan designation - Commission Decision (2018)4181 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/012/18

Europe -DG Health and Food Safety

27-6-2018

Yondelis (Pharma Mar S.A.)

Yondelis (Pharma Mar S.A.)

Yondelis (Active substance: Trabectedin) - PSUSA - Modification - Commission Decision (2018)4096 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/3001/201709

Europe -DG Health and Food Safety

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

11-6-2018

Cimzia (UCB Pharma S.A.)

Cimzia (UCB Pharma S.A.)

Cimzia (Active substance: certolizumab pegol ) - Centralised - 2-Monthly update - Commission Decision (2018)3768 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1037/II/65

Europe -DG Health and Food Safety