Miacalcic mite 100

Informazioni principali

  • Nome commerciale:
  • Miacalcic mite 100 Nasalspray
  • Forma farmaceutica:
  • Nasalspray
  • Composizione:
  • calcitoninum salmonis 100 U.I. pro dosi, conserv.: benzalkonii chloridum, excipiens ad solutionem pro dosi.
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco biologico

Documenti

  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


    Richiedi il foglio illustrativo per i professionisti.

Localizzazione

  • Disponibile in:
  • Miacalcic mite 100 Nasalspray
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Biotechnologika
  • Area terapeutica:
  • Morbus Paget, Hyperkalzämie, Algodystrophie, postmenopausale Osteoporose bei Nichtdurchführbarkeit anderer Therapien

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 47473
  • Data dell'autorizzazione:
  • 18-03-1986
  • Ultimo aggiornamento:
  • 05-02-2018

Foglio illustrativo: composizione, posologia, indicazioni, interazioni, gravidanza, allattamento, effetti indesiderati, controindicazioni

Patienteninformation

Miacalcic® Spray nasal

Future Health Pharma GmbH

Che cos’è Miacalcic e quando si usa?

Miacalcic contiene, quale sostanza attiva, calcitonina di salmone sintetica.

La calcitonina è un ormone prodotto dall'organismo dei vertebrati e dell'uomo quale sostanza

endogena, ed è indispensabile per la regolazione di numerose funzioni.

Tra le diverse calcitonine, la calcitonina di salmone è una delle sostanze più attive a livello biologico.

Miacalcic possiede le stesse proprietà dell'ormone naturale, ma è privo di contaminazione da proteine

animali.

La proprietà più importante della calcitonina è la regolazione del metabolismo del calcio. Miacalcic

frena la riduzione patologica della massa ossea ed esplica inoltre in certi casi un forte effetto

analgesico. Miacalcic viene pertanto utilizzato soprattutto per il trattamento di malattie ossee

dolorose legate a un'eccessiva riduzione del tessuto osseo per esempio:

·per la prevenzione dell'atrofia ossea acuta (osteoporosi) a causa di un'improvvisa immobilizzazione,

come nelle fratture ossee osteoporotiche.

In caso di atrofia ossea, il suo medico le consiglierà l'assunzione di un preparato a base di calcio

durante il trattamento con Miacalcic.

·il morbo di Paget

Miacalcic deve essere utilizzato solo per il trattamento del morbo di Paget qualora altre terapie non

possano essere impiegate, oppure si siano dimostrate inefficaci. Nel morbo di Paget, la durata del

trattamento dipende dal quadro generale della malattia e dalla sua risposta terapeutica.

·Malattia di Sudeck

Per la malattia di Sudeck, un'affezione delle ossa e delle parti molli che può anche sopravvenire in

seguito ad una frattura ossea, Miacalcic esplica anche un effetto antiosteolitico.

Indicazioni generali di impiego

Il trattamento con Miacalcic dovrebbe durare il minor tempo possibile ed essere limitato alla dose

minima efficace.

Miacalcic dev'essere usato solamente su prescrizione medica.

Di che cosa occorre inoltre tener conto durante il trattamento?

In funzione del fabbisogno individuale, Miacalcic dev'essere somministrato con un quantitativo

sufficiente di calcio e di vitamina D per prevenire una riduzione progressiva della massa ossea.

Quando non si può assumere Miacalcic?

Miacalcic non dev'essere somministrato in caso di ipersensibilità o di reazioni allergiche note a

questo medicamento.

Quando è richiesta prudenza nella somministrazione di Miacalcic?

Questo medicamento può ridurre la capacità di reazione, la capacità di condurre un veicolo e la

capacità di utilizzare attrezzi o macchine!

Miacalcic può temporaneamente provocare stanchezza, vertigini e disturbi del viso. Se compaiono

questi effetti collaterali non deve guidare veicoli o utilizzare macchine.

L'assunzione di Miacalcic per un tempo prolungato potrebbe aumentare il rischio di cancro. Risulta

pertanto importante che lo utilizzi seguendo esattamente le prescrizioni del Suo medico.

In rarissimi casi possono manifestarsi delle reazioni locali o generalizzate di ipersensibilità (eruzioni

cutanee, difficoltà respiratorie, ecc.). In questi casi, informi il suo medico, che deciderà se occorre

interrompere la terapia con Miacalcic.

Informi il Suo medico qualora debba assumere un farmaco contenente litio.Si dovrà possibilmente

adeguare il dosaggio del litio.

Informi il suo medico o il suo farmacista nel caso in cui

·soffre di altre malattie,

·soffre di allergie o

·assume o applica esternamente altri medicamenti (anche acquistati di sua iniziativa!).

Si può usare Miacalcic durante la gravidanza o l’allattamento?

In caso di gravidanza o qualora si intenda restare incinta, non assumere Miacalcic. L'assunzione è

sconsigliata durante l'allattamento. Prima di utilizzare Miacalcic, ne parli con il Suo medico in caso

di gravidanza, di una Sua prossima intenzione o se allatta.

Come usare Miacalcic?

Il suo medico le prescriverà lo spray nasale Miacalcic con un dosaggio adeguato al suo caso

specifico. Il dosaggio varia secondo il tipo e la gravità del caso2 nebulizzazioni di Miacalcic mite

100, spray nasale, oppure 1 nebulizzazione di Miacalcic 200, spray nasale al giorno.Non modifichi di

propria iniziativa la posologia prescritta. Il medico le darà istruzioni precise sulla durata del

trattamento. È opportuno che non prosegua il trattamento oltre la data indicata dal medico. Se ritiene

che l'azione del medicamento sia troppo debole o troppo forte ne parli al suo medico o al suo

farmacista.

Dato che Miacalcic non penetra nell'organismo attraverso il sistema digerente, bensì viene assorbito

attraverso la mucosa nasale, non ha importanza se viene usato prima o dopo i pasti.

Utilizzi lo spray nasale secondo le istruzioni d'uso sottostante. Prima dell'uso, è molto importante

attivare tre volte il dispositivo di nebulizzazione, finché appare il simbolo verde nella finestrella

all'estremità inferiore del nebulizzatore.

Se dimentica di nebulizzare una dose di spray, l'effetto non cambia, sempre che si ricordi di

nebulizzare le dosi successive al momento prescritto.

Se l'ugello dovesse bloccarsi, cerchi di sbloccarlo premendo forte l'atomizzatore verso il basso

(nebulizzazione forzata). Non utilizzi oggetti taglienti, che potrebbero danneggiare il sistema di

nebulizzazione, impedendo così la fuoriuscita del dosaggio esatto.

Quali effetti collaterali può avere Miacalcic?

Con l'applicazione di Miacalcic possono manifestarsi i seguenti effetti collaterali:

Molto frequenti: infiammazioni della mucosa nasale (incl. naso secco, naso gonfio o naso chiuso,

starnuti, infiammazione allergica della mucosa nasale), sintomi aspecifici (ad es. sensazione di

dolore, formazione di noduli, odore fetido, irritazioni, tumefazioni, escoriazioni).

Frequenti: infiammazione nel naso con lesioni alla mucosa, sinusite, sangue dal naso.

Frequenti: improvviso rossore e sensazione di calore al viso, stordimento, mal di testa, vertigini,

nausea, diarrea, dolori addominali, dolori articolari, faringite, stanchezza, alterazione del senso del

gusto.

Occasionali: ipertensione, vomito, dolori muscolari, tosse, sintomi di tipo influenzale, tumefazioni

(al viso, alle braccia e alle gambe o a tutto il corpo), capacità visiva alterata.

Rari: reazioni d'ipersensibilità, prurito della pelle, eruzione cutanea (a volte su tutto il corpo).

Dopo l'immissione in commercio sono stati inoltre osservati tremore e ridotto tasso ematico di calcio

(a volte causa di crampi).

In studi clinici sull'uso a lungo termine di calcitonina è stato osservato un aumento del rischio di

tumori (vedi «Quando prestare attenzione all'assunzione di Miacalcic?»).

Se osserva effetti collaterali qui non descritti dovrebbe informare il suo medico o il suo farmacista.

Di che altro occorre tener conto?

Il medicamento dev'essere conservato fuori della portata dei bambini.

Miacalcic spray nasale dev'essere conservato in frigorifero (2-8 °C). Ciò è il caso però solo fino al

primo impiego. Lo spray nasale dev'essere protetto dal gelo. Non congelare. Una volta aperto, è

preferibile conservarlo a temperatura ambiente (15–25 °C) in posizione verticale. Dev'essere

utilizzato entro 4 settimane.

Le confezioni intatte di Miacalcic spray nasale non devono essere utilizzate oltre la data indicata con

«EXP» sulla confezione.

Il medico o il farmacista, che sono in possesso di un'informazione professionale dettagliata, possono

darle ulteriori informazioni.

Cosa contiene Miacalcic?

1 flacone di spray nasale da 1400 o 2800 U.I. contiene:

Sostanza attiva: calcitonina di salmone sintetica 100 o 200 U.I. per nebulizzazione.

Conservante: cloruro di benzalconio e altri eccipienti.

Numero dell’omologazione

47473 (Swissmedic).

Dov’è ottenibile Miacalcic? Quali confezioni sono disponibili?

Miacalcic è in vendita in farmacia, dietro presentazione della prescrizione medica nelle confezioni

seguenti:

Spray nasale mite 100

1 flacone per un totale di almeno 1400 U.I.

2 flaconi (confezione a due) per un totale di almeno 2800 U.I.

Spray nasale 200

1 flacone per un totale di almeno 2800 U.I.

Titolare dell’omologazione

Future Health Pharma GmbH, 8620 Wetzikon ZH.

Questo foglietto illustrativo è stato controllato l'ultima volta nel gennaio 2015 dall'autorità

competente in materia di medicamenti (Swissmedic).

Istruzioni per l’uso

1.Tolga il cappuccio di protezione (fig. 1).

2.Solo al primo uso: tenga lo spray nasale come illustrato (fig. 2), spinge la pompa di dosaggio con

forza verso il basso finché sente un «clic», poi lo lasci. Ripetere l’operazione due volte. Nella

finestrina nell’estremità inferiore del nebulizzatore compare ora il simbolo verde, con ciò, lo spray

nasale è pronto per l’uso.

3.Inclini la testa leggermente in avanti e introduca il dosatore in una narice in modo tale per

permettere che la nebulizzazione si distribuisse uniformemente, vale a dire che l’apertura del

nebulizzatore non è rivolta verso la parete nasale. Spinga il dosatore UNA VOLTA (velocemente e

con forza) verso il basso e lo lasci (vedi fig. 3). Nella finestrina del contatore compare ora il numero

4.Dopo l’applicazione ispiri più volte energicamente con il naso per evitare una fuoriuscita della

soluzione dal naso. Non si pulisca il naso subito dopo l’applicazione.

5.Nel caso in cui il medico le ha prescritto più di un’applicazione, applichi un’altra nebulizzazione

anche nell’altra narice secondo i punti 3 e 4 (fig. 4).

6.Rimetta il cappuccio di protezione dopo l’uso per evitare efficientemente l’intasamento

dell’iniettore.

7.Lo spray nasale garantisce l’erogazione di 14 dosi. È possibile che riesca a ricavarne altre due dosi.

Dopo 14 nebulizzazioni compare il numero «15» nero, poi il numero «16» rosso nella finestrina del

contatore e una resistenza ben avvertibile rende l’ulteriore azione del dosatore più difficile (stop di

avvertimento). Un resto (sovrariempimento per motivi tecnici) rimane nel flacone. Nel caso in cui il

dosatore viene attivato lo stesso di nuovo, non può essere garantito un dosaggio sufficiente.

8.Non provi in nessun caso di allargare l’iniettore con un ago o con un oggetto a punta poiché, con

ciò, la sua funzionalità viene rovinata del tutto. Non smonti la pompa. In caso di qualsiasi mancanza

di chiarezza chieda per favore consiglio al suo farmacista. Conservi o trasporti il flacone sempre in

posizione verticale, ciò garantisce un dosaggio uniforme. Eviti che il flacone venga agitato, eviti le

temperature estreme.

9.Una volta applicato lo spray nasale per la prima volta, è meglio conservarlo a temperatura ambiente

normale in posizione verticale, per evitare la formazione di bolle d’aria nel tubetto che sale nel

nebulizzatore, dato che le bolle potrebbero compromettere il dosaggio corretto delle nebulizzazioni.

Lo spray deve poi essere usato entro quattro settimane.

22-1-2019

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

22-1-2019

PurpleAir recalls PowerStream power supplies for PA-II and PA-II-SD air quality sensors

PurpleAir recalls PowerStream power supplies for PA-II and PA-II-SD air quality sensors

PurpleAir has received reports of thermal events (arcing, sparking, smoking) originating in the power supplies. The thermal event is limited to the power supply and not PurpleAir’s air sensors, but the arcing, sparking, and smoking may pose a risk of fire if combustible material is near the power supply when it experiences a thermal event. Discoloration can result on the surface where a power supply is mounted.

Health Canada

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Published on: Tue, 15 Jan 2019 The additive 3‐phytase FSF10000 is a solid product that contains a 3‐phytase produced by a genetically modified strain of Komagataella phaffii. A liquid formulation of the additive has been previously assessed by the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) and is currently authorised as a feed additive for poultry species. The applicant requested for the use of this new formulation of the additive in chickens for fattening or reared ...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Published on: Mon, 14 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) when used as an additive at up to ■■■■■ in polylactic acid (PLA) bottles intended for contact with water for long‐term storage at ambient temperature or below. The modified clay, which 90% w/w of the particles have a dimension of 33.1 μm or less and the average size is 9 μm, has a layered structure w...

Europe - EFSA - European Food Safety Authority EFSA Journal

3-1-2019

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.

FDA - U.S. Food and Drug Administration

3-1-2019

Loblaw Companies Limited recalls Life at Home 50 Count Indoor LED Microdot Icicle Lights

Loblaw Companies Limited recalls Life at Home 50 Count Indoor LED Microdot Icicle Lights

Due to a potential manufacturing defect the lights may overheat, posing a burn and fire hazard.

Health Canada

20-12-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinog...

FDA - U.S. Food and Drug Administration

20-12-2018

Loblaw Companies Limited recalls Joe Fresh Baby Girls' Running Shoe

Loblaw Companies Limited recalls Joe Fresh Baby Girls' Running Shoe

The hook and loop fastener on the shoe may detach which could pose as a choking hazard for young children.

Health Canada

20-12-2018

Pest categorisation of Gymnosporangium spp. (non‐EU)

Pest categorisation of Gymnosporangium spp. (non‐EU)

Published on: Wed, 19 Dec 2018 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Gymnosporangium spp. (non‐EU), a well‐defined and distinguishable group of fungal plant pathogens of the family Pucciniaceae affecting woody species. Many different Gymnosporangium species are recognised, of which at least 14 species are considered not to be native in the European Union. All the non‐EU Gymnosporangium species are not known to be present in th...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Pest categorisation of Cronartium spp. (non‐EU)

Pest categorisation of Cronartium spp. (non‐EU)

Published on: Wed, 19 Dec 2018 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium spp. (non‐EU), a well‐defined and distinguishable group of fungal pathogens of the family Cronartiaceae. There are at least 40 species described within the Cronartium genus, of which two are considered native to the EU (C. gentianeum and C. pini) and one has been introduced in the 19th century (C. ribicola) and is now widespread in the EU – these t...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018


Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2

Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2

Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2

Europe - EMA - European Medicines Agency

13-12-2018

FDA Works to Keep Injectable Opioids Available to Treat Animals’ Surgical and Trauma Pain During Ongoing Supply Shortage

FDA Works to Keep Injectable Opioids Available to Treat Animals’ Surgical and Trauma Pain During Ongoing Supply Shortage

In its continuing mission to protect animal health, the U.S. Food and Drug Administration announced that it has worked with Pfizer Inc to alleviate a shortage of injectable opioids available to treat pain in animals, by facilitating the availability of a limited amount of product labeled for humans.

FDA - U.S. Food and Drug Administration

12-12-2018

Del Monte Foods Announces Limited Recall of Canned Fiesta Corn Seasoned with Red & Green Peppers Due to Under Processing

Del Monte Foods Announces Limited Recall of Canned Fiesta Corn Seasoned with Red & Green Peppers Due to Under Processing

Del Monte Foods Inc. announced a recall of 64,242 cases of FIESTA CORN Seasoned with Red & Green Peppers due to under-processing. These deviations were part of the commercial sterilization process and could result in contamination by spoilage organisms or pathogens, which could lead to life-threatening illness if consumed. It is important to note that there have been no reports of illness associated with these products to date. No other production codes or products are affected by this recall.

FDA - U.S. Food and Drug Administration

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

Published on: Mon, 26 Nov 2018 Abstract In response to the EFSA call New approaches in identifying and characterizing microbial and chemical hazards, the project INNUENDO (https://sites.google.com/site/theinnuendoproject/) aimed to design an analytical platform and standard procedures for the use of whole‐genome sequencing in surveillance and outbreak investigation of food‐borne pathogens. The project firstly attempted to identify existing flaws and needs, and then to provide applicable cross‐sectorial ...

Europe - EFSA - European Food Safety Authority Publications

22-11-2018

Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Extreme 5

Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Extreme 5

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients and/or unacceptable contaminant(s).

Health Canada

22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

17-1-2019

Natpar (Shire Pharmaceuticals Ireland Limited)

Natpar (Shire Pharmaceuticals Ireland Limited)

Natpar (Active substance: parathyroid hormone) - PSUSA - Modification - Commission Decision (2019)269 of Thu, 17 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10591/201804

Europe -DG Health and Food Safety

17-1-2019

Anoro Ellipta (GlaxoSmithKline (Ireland) Limited)

Anoro Ellipta (GlaxoSmithKline (Ireland) Limited)

Anoro Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Renewal - Commission Decision (2019)267 of Thu, 17 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2751/R/22

Europe -DG Health and Food Safety

16-1-2019

Ovaleap (Theramex Ireland Limited)

Ovaleap (Theramex Ireland Limited)

Ovaleap (Active substance: Follitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)189 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002608/T/0027

Europe -DG Health and Food Safety

16-1-2019

EU/3/08/586 (Sarepta Therapeutics Ireland Limited)

EU/3/08/586 (Sarepta Therapeutics Ireland Limited)

EU/3/08/586 (Active substance: RNA, [P-deoxy-P-(dimethylamino)] (2',3'-dideoxy-2',3'-imino-2',3'-seco) (2'a?5')(C-m5U-C-C-A-A-C-A-m5U-C-A-A-G-G-A-A-G-A-m5U-G-G-C-A-m5U-m5U-m5U-C-m5U-A-G), P-[4-[[2-[2-(2-hydroxyethoxy)ethoxy] ethoxy]carbonyl]-1-piperazinyl]-N,N-dimethylaminophosphonamidate) - Transfer of orphan designation - Commission Decision (2019)235 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003068

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2130 (Arena Pharmaceuticals Limited)

EU/3/18/2130 (Arena Pharmaceuticals Limited)

EU/3/18/2130 (Active substance: Ralinepag) - Orphan designation - Commission Decision (2019)239 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002037

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2126 (Hanmi Europe Limited)

EU/3/18/2126 (Hanmi Europe Limited)

EU/3/18/2126 (Active substance: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment) - Orphan designation - Commission Decision (2019)222 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001592

Europe -DG Health and Food Safety

15-1-2019

Symkevi (Vertex Pharmaceuticals (Ireland) Limited)

Symkevi (Vertex Pharmaceuticals (Ireland) Limited)

Symkevi (Active substance: tezacaftor/ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)188 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004682/T/0003

Europe -DG Health and Food Safety

9-1-2019

Thymanax (Servier (Ireland) Industries Limited)

Thymanax (Servier (Ireland) Industries Limited)

Thymanax (Active substance: agomelatine) - Centralised - Renewal - Commission Decision (2019)71 of Wed, 09 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/916/R/40

Europe -DG Health and Food Safety

9-1-2019

Omidria (Omeros London Limited)

Omidria (Omeros London Limited)

Omidria (Active substance: phenylephrine / ketorolac) - Centralised - Yearly update - Commission Decision (2019)68 of Wed, 09 Jan 2019

Europe -DG Health and Food Safety

20-12-2018

Ravicti (Horizon Pharma Ireland Limited)

Ravicti (Horizon Pharma Ireland Limited)

Ravicti (Active substance: Glycerol phenylbutyrate) - Centralised - 2-Monthly update - Commission Decision (2018)9126 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3822/II/19

Europe -DG Health and Food Safety

19-12-2018

Zubsolv (Mundipharma Corporation (Ireland) Limited)

Zubsolv (Mundipharma Corporation (Ireland) Limited)

Zubsolv (Active substance: buprenorphine / naloxone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)9063 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004407/T/0003

Europe -DG Health and Food Safety

19-12-2018

EU/3/15/1545 (Seagen Ireland Limited)

EU/3/15/1545 (Seagen Ireland Limited)

EU/3/15/1545 (Active substance: CD33-directed antibody-drug conjugate consisting of an antibody conjugated to a DNA cross-linking pyrrolobenzodiazepine dimer drug) - Transfer of orphan designation - Commission Decision (2018)9039 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002611

Europe -DG Health and Food Safety

19-12-2018

Kisqali (Novartis Europharm Limited)

Kisqali (Novartis Europharm Limited)

Kisqali (Active substance: ribociclib) - Centralised - 2-Monthly update - Commission Decision (2018)9068 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4213/II/0004

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2123 (IQVIA RDS Ireland Limited)

EU/3/18/2123 (IQVIA RDS Ireland Limited)

EU/3/18/2123 (Active substance: 6,8-bis(benzylthio)octanoic acid) - Orphan designation - Commission Decision (2018)9038 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/169/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2118 (Eiger Biopharmaceuticals Europe Limited)

EU/3/18/2118 (Eiger Biopharmaceuticals Europe Limited)

EU/3/18/2118 (Active substance: Lonafarnib) - Orphan designation - Commission Decision (2018)9033 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/159/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2117 (Vertex Pharmaceuticals (Europe) Limited)

EU/3/18/2117 (Vertex Pharmaceuticals (Europe) Limited)

EU/3/18/2117 (Active substance: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor) - Orphan designation - Commission Decision (2018)9032 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/137/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2116 (Vertex Pharmaceuticals (Europe) Limited)

EU/3/18/2116 (Vertex Pharmaceuticals (Europe) Limited)

EU/3/18/2116 (Active substance: Ivacaftor, N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide, tezacaftor) - Orphan designation - Commission Decision (2018)9031 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/139/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2114 (Shire Pharmaceuticals Ireland Limited)

EU/3/18/2114 (Shire Pharmaceuticals Ireland Limited)

EU/3/18/2114 (Active substance: C1 esterase inhibitor (human)) - Orphan designation - Commission Decision (2018)9029 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/173/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/17/1828 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/17/1828 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/17/1828 (Active substance: 1-(2,2-difluoro-2H-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropane-1-carboxamide and ivacaftor) - Transfer of orphan designation - Commission Decision (2018)9017 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002757

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2105 (IQVIA RDS Ireland Limited)

EU/3/18/2105 (IQVIA RDS Ireland Limited)

EU/3/18/2105 (Active substance: 6,8-bis(benzylthio)octanoic acid) - Orphan designation - Commission Decision (2018)9020 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/167/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2104 (Novartis Europharm Limited)

EU/3/18/2104 (Novartis Europharm Limited)

EU/3/18/2104 (Active substance: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1))) - Orphan designation - Commission Decision (2018)9019 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/157/18

Europe -DG Health and Food Safety

14-12-2018


Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market - Revsion 2

Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market - Revsion 2

Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market - Revsion 2

Europe - EMA - European Medicines Agency

14-12-2018

Revinty Ellipta (GlaxoSmithKline (Ireland) Limited)

Revinty Ellipta (GlaxoSmithKline (Ireland) Limited)

Revinty Ellipta (Active substance: fluticasone furoate / vilanterol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8927 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2745/T/38

Europe -DG Health and Food Safety

14-12-2018

Relvar Ellipta (GlaxoSmithKline (Ireland) Limited)

Relvar Ellipta (GlaxoSmithKline (Ireland) Limited)

Relvar Ellipta (Active substance: fluticasone furoate/vilanterol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8928 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2673/T/40

Europe -DG Health and Food Safety

12-12-2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98

Therapeutic Goods Administration - Australia

12-12-2018

TGA operations over the holiday period 2018-19

TGA operations over the holiday period 2018-19

The TGA will have limited operations from Monday 24 December 2018 until Wednesday 2 January 2018

Therapeutic Goods Administration - Australia

11-12-2018

Rubraca (Clovis Oncology Ireland Limited)

Rubraca (Clovis Oncology Ireland Limited)

Rubraca (Active substance: rucaparib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8686 of Tue, 11 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4272/T/5

Europe -DG Health and Food Safety

10-12-2018

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (Active substance: ivabradine) - Centralised - Withdrawal - Commission Decision (2018)8623 of Mon, 10 Dec 2018

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (Active substance: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein) - Transfer of orphan designation - Commission Decision (2018)8634 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002509

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (Active substance: Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase) - Transfer of orphan designation - Commission Decision (2018)8632 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002508

Europe -DG Health and Food Safety

10-12-2018

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Active substance: Mercaptopurine (oral suspension)) - Transfer of orphan designation - Commission Decision (2018)8629 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002301

Europe -DG Health and Food Safety

29-11-2018

alli (GlaxoSmithKline Dungarvan Limited)

alli (GlaxoSmithKline Dungarvan Limited)

alli (Active substance: Orlistat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8041 of Thu, 29 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/854/T/59

Europe -DG Health and Food Safety

29-11-2018

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)8036 of Thu, 29 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2497/X/15

Europe -DG Health and Food Safety

28-11-2018

Zeffix (GlaxoSmithKline (Ireland) Limited)

Zeffix (GlaxoSmithKline (Ireland) Limited)

Zeffix (Active substance: Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8044 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/242/T/73

Europe -DG Health and Food Safety

28-11-2018

Orkambi (Vertex Pharmaceuticals (Ireland) Limited)

Orkambi (Vertex Pharmaceuticals (Ireland) Limited)

Orkambi (Active substance: Lumacaftor/Ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8042 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3954/T/39

Europe -DG Health and Food Safety

28-11-2018

GILENYA (Novartis Europharm Limited)

GILENYA (Novartis Europharm Limited)

GILENYA (Active substance: Fingolimod) - Centralised - Variation - Commission Decision (2018)7969 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2202/X/44

Europe -DG Health and Food Safety

28-11-2018

Kalydeco (Vertex Pharmaceuticals (Ireland) Limited)

Kalydeco (Vertex Pharmaceuticals (Ireland) Limited)

Kalydeco (Active substance: ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8047 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2494/T/71

Europe -DG Health and Food Safety

26-11-2018

Atripla (Bristol-Myers Squibb and Gilead Sciences Limited)

Atripla (Bristol-Myers Squibb and Gilead Sciences Limited)

Atripla (Active substance: efavirenz / emtricitabine / tenofovir disoproxil fumarate) - Centralised - 2-Monthly update - Commission Decision (2018)7982 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/797/II/130

Europe -DG Health and Food Safety

26-11-2018

Nyxoid (Mundipharma Corporation (Ireland) Limited)

Nyxoid (Mundipharma Corporation (Ireland) Limited)

Nyxoid (Active substance: naloxone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7966 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4325/T/04

Europe -DG Health and Food Safety

26-11-2018

TAKHZYRO (Shire Pharmaceuticals Ireland Limited)

TAKHZYRO (Shire Pharmaceuticals Ireland Limited)

TAKHZYRO (Active substance: lanadelumab) - Centralised - Authorisation - Commission Decision (2018)7971 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004806/0000

Europe -DG Health and Food Safety

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Europe - EMA - European Medicines Agency

22-11-2018

Brineura (BioMarin International Limited)

Brineura (BioMarin International Limited)

Brineura (Active substance: cerliponase alfa) - Centralised - Yearly update - Commission Decision (2018)7885 of Thu, 22 Nov 2018

Europe -DG Health and Food Safety

22-11-2018

Incruse Ellipta (GlaxoSmithKline (Ireland) Limited)

Incruse Ellipta (GlaxoSmithKline (Ireland) Limited)

Incruse Ellipta (Active substance: umeclidinium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7876 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2809/T/22

Europe -DG Health and Food Safety

22-11-2018

Levetiracetam Hospira (Hospira UK Limited)

Levetiracetam Hospira (Hospira UK Limited)

Levetiracetam Hospira (Active substance: levetiracetam) - Centralised - Renewal - Commission Decision (2018)7895 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2783/R/18

Europe -DG Health and Food Safety

22-11-2018

Vabomere (Rempex London Limited)

Vabomere (Rempex London Limited)

Vabomere (Active substance: meropenem/vaborbactam) - Centralised - Authorisation - Commission Decision (2018)7888 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4669/00

Europe -DG Health and Food Safety