natgillin/translations-raw huggingface dataset:
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Suliqua 100 enheder/ml +50 mikrog/ml injektion insulin glargin + lixisenatid s.c. 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Suliqua 100 units/mL + 50 mcg/mL solution for injection insulin glargine + lixisenatide
Er du i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet. 
- If you have any further questions, ask your doctor or pharmacist or nurse.
Du må ikke injicere en dosis, der er under 10 dosistrin, eller en dosis, der er over 40 dosistrin. 
Do not inject a dose higher than 40 dose steps.
• At det er den rigtige medicin. 
• Ensure that you use the right medicine.
Sådan skal du tage Suliqua 
How to use Suliqua
• Tilstanden udvikles langsomt, når du får lavt blodsukker. 
• Your low blood sugar comes on slowly.
A. Tag fat om den tykke del af den yderste nålehætte. 
Grip and squeeze the widest part of the outer needle cap.
- udskift nålen (se TRIN 6 og TRIN 2), 
If this happens: - change the needle (see STEP 6 and STEP 2), - then repeat the safety test (STEP 3).
Der er ikke nogen erfaring med anvendelse af Suliqua til børn og unge under 18 år. 
There is no experience with Suliqua in children and adolescents aged less than 18 years, therefore, the use of Suliqua is not recommended in this age group.
Tomme penne må aldrig genbruges og skal bortskaffes på forsvarlig vis. For at undgå overførsel af sygdomme, må pennen kun anvendes af den samme patient. 
Empty pens must never be reused and must be properly discarded.
Tidligere behandling 
Previous therapy
10x3 ml penne 
10x 3 mL pens
Suliqua 100 enheder/ml + 33 mikrogram/ml injektionsvæske, opløsning, i en fyldt pen Hver fyldt pen indeholder 300 enheder insulin glargin* og 100 mikrogram lixisenatid i 3 ml injektionsvæske. 
Suliqua 100units/ml + 33 microgram/ml solution for injection in a pre-filled pen Each pre-filled pen contains 300 units of insulin glargine and 100 micrograms Lixisenatide in 3 ml solution.
E. Slip injektionsknappen, når du har holdt den inde, mens du langsomt talte til 10. 
E. After holding and slowly counting to 10, release the injection button.
Forskel i andel versus insulin glargin [95 % KI] (p-værdi) 
Proportion difference versus insulin glargine [95% confidence interval] (p-value)
• en kanylebeholder til brugte nåle og penne (se Bortskaffelse af din pen). 
• a sharps container for used needles and pens.
Til dosistrin fra 30-60 enheder findes der en fyldt pen med Suliqua 100 enheder/ml + 33 mikrogram/ml injektionsvæske. 
For dose steps from 30-60 units, Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen is available.
Gem denne brugervejledning, du kan få brug for at læse den på et senere tidspunkt. 
Keep these Instructions For Use leaflet for future reference.
LS-forskel versus glargin (gennemsnit) [95 % KI] 
LS difference versus glargine (mean) [95%CI]
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Suliqua: 
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Suliqua if:
Suliqua kan påvirke virkningen af bestemte typer lægemidler, der indtages gennem munden. 
The effect of some medicines you swallow might be affected by Suliqua.
Det skal du vide, før du begynder at tage Suliqua Sådan skal du tage Suliqua Bivirkninger 
What Suliqua is and what it is used for What you need to know before you use Suliqua How to use Suliqua
Faste-plasmaglucose (mmol/l) Baseline (gennemsnit) Ved afslutning af studie (gennemsnit) LS-ændring fra baseline (gennemsnit) LS-forskel versus glargin (gennemsnit) [95 % KI] (p-værdi) 
HbA1c (%) Baseline (mean; post run-in phase) End of study (mean) LS change from baseline (mean) Difference vs. insulin glargine [95% confidence interval] (p-value) Difference vs. lixisenatide [95% confidence interval] (p-value) Number of Patients (%) reaching HbA1c <7% at week 30* Fasting plasma glucose (mmol/L) Baseline (mean) End of study (mean) LS change from baseline (mean) LS difference versus glargine (mean) [95%CI] (p-value)
Daglig dosis insulin glargin 
Suliqua Insulin glargine
Læg ikke pennen tilbage i køleskabet. 
Do not return the pen to a refrigerator and do not freeze.
Ikke-anbrudte penne 
Not in-use pens.
Når du har valgt det måltid, der passer dig bedst, er det bedst at injicere Suliqua før det samme måltid hver dag. 
Preferably inject Suliqua before the same meal every day, when you have chosen the most convenient way.
Hver ml indeholder 100 enheder insulin glargin og 33 mikrogram lixisenatid. 
Each ml contains 100 units of insulin glargine and 33 micrograms lixisenatide.
Suliqua 100 enheder/ml + 33 mikrogram/ml injektionsvæske, opløsning, i en fyldt pen Insulin glargin + lixisenatid 
Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen Insulin glargine + lixisenatide
Suliqua 100 enheder/ml + 50 mikrogram/ml injektionsvæske, opløsning, i en fyldt pen Suliqua 100 enheder/ml + 33 mikrogram/ml injektionsvæske, opløsning, i en fyldt pen 
Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen
Hver ml indeholder 100 enheder insulin glargin og 50 mikrogram lixisenatid. 
Each mL contains 100 units of insulin glargine and 50 micrograms lixisenatide.
LS-ændring fra baseline (gennemsnit) Forskel versus insulin glargin [95 % KI] (p-værdi) 
LS change from baseline (mean) Difference versus insulin glargine [95% confidence interval] (p-value)
Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium per dosis, dvs. det er i det væsentlige 'natriumfrit'. 
Important information about some of the ingredients of Suliqua This medicine contains less than 1 mmol (23 mg) sodium per dose.
Suliqua 100 enheder/ml + 50 mikrogram/ml injektionsvæske, opløsning i en fyldt pen 
Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen
LS-ændring fra baseline (gennemsnit) Sammenligning med insulin glargin [95 % KI] (p-værdi) 
LS change from baseline (mean) Comparison versus insulin glargine [95% confidence interval] (p-value)
• Opbevar altid penne med påsat hætte. 
• Store the pen with your pen cap on.
Hvis du har sprunget en dosis Suliqua over, kan dit blodsukker blive for højt (hyperglykæmi): Hvis det er nødvendigt, kan du injicere Suliqua inden dit næste måltid. 
If you have missed a dose of Suliqua or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia):
Suliqua 100 enheder/ml + 50 mikrogram/ml injektionsvæske, opløsning, i en fyldt pen insulin glargin + lixisenatid 
Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen Insulin glargine + lixisenatide
• Hvert dosistrin, som du indstiller pennen til, indeholder 1 enhed insulin glargin og 0,5 mikrogram lixisenatid. 
• Each dose step you dial contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide.
Hver pen indeholder 300 enheder insulin glargin og 150 mikrogram lixisenatid i 3 ml injektionsvæske. 
Each pen contains 300 units insulin glargine and 150 micrograms lixisenatide in 3 ml of solution.
Ved afslutning af studie (gennemsnit) 
End of study (mean)
Når der kommer væske ud af nålespidsen, fungerer pennen korrekt. 
• When medicine comes out of the needle tip, your pen is working correctly, the dose selector will be reset to “0”.
Antal patienter [n (%)], der opnåede HbA1c <7 % ved uge 30* 
Patients [n (%)] reaching HbA1c <7% at week 30* Fasting plasma glucose (mmol/L) Baseline (mean)
Opbevaring af pennen 
How to store your pen
Hvert dosistrin Suliqua indeholder 1 enhed insulin glargin og 0,5 mikrogram lixisenatid. 
Each dose step of Suliqua contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide,.
Suliqua 100 enheder/ml + 50 mikrogram/ml injektionsvæske, opløsning, i en fyldt pen Suliqua 100 enheder/ml + 33 mikrogram/ml injektionsvæske, opløsning, i en fyldt pen insulin glargin + lixisenatid 
NAME OF THE MEDICINAL PRODUCT Suliqua 100 units/mL + 50 micrograms/mL solution for injection in a pre-filled pen Suliqua 100 units/mL + 33 micrograms/mL solution for injection in a pre-filled pen insulin glargine + lixisenatide
Hvert dosistrin indeholder 1 enhed insulin glargin og 0,5 mikrogram lixisenatid. 
Each dose step contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide.
Hver pen indeholder 300 enheder insulin glargin og 100 mikrogram lixisenatid i 3 ml injektionsvæske. 
Each pen contains 300 units of insulin glargine and 100 micrograms lixisenatide in 3 mL solution.
Hvert dosistrin indeholder 1 enhed insulin glargin og 0,33 mikrogram lixisenatid. 
Each dose step contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide.
Hos patienter med nedsat leverfunktion kan hyppig glucosemonitorering og dosisjustering af Suliqua være nødvendig. 
Frequent glucose monitoring and dose adjustment may be necessary for Suliqua in patients with hepatic impairment.
Hvis du har taget for meget Suliqua 
If you use more Suliqua than you should
For ikke at overskride den anbefalede startdosis af lixisenatid på 10 mikrog henvises til nedenstående skema: 
The starting dose of Suliqua isbased on previous anti-diabetic treatment, and in order not to exceed the recommended lixisenatide starting dose of 10 mcg:
Pennen må ikke opbevares med påsat nål. 
Do not store the pen with the needle attached.
D. Sæt hætten tilbage på pennen. 
D. Put your pen cap back on. • Do not put the pen back in the refrigerator.
* enheder insulin glargin (100 enheder/ml) / mikrogram lixisenatid 
30 dose steps (30 units/10 mcg)* * units insulin glargine (100 units/ml) / mcg lixisenatide
• Hvert dosistrin, som du indstiller pennen til, indeholder 1 enhed insulin glargin og 0,33 mikrogram lixisenatid. 
• Each dose step of Suliqua you dial contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide.
LS-forskel versus lixisenatid (gennemsnit) [95 % KI] 
LS difference versus lixisenatide (mean) [95%CI]
Hold nålen vandret, og før den ind i den yderste nålehætte. 
A. Grip the widest part of the outer needle cap. Keep the needle straight and guide it into the outer needle cap back.
Penhætte 
Subcutaneous use
Suliqua kan ikke anbefales til patienter med svært nedsat nyrefunktion eller terminal nyresygdom (se pkt. 
Use is not recommended in patients with severe renal impairment or end-stage renal disease (see sections 4.2 and 5.2).
Der er ikke udført specifikke studier med henblik på at undersøge Suliquas kardiovaskulære sikkerhed. 
No dedicated cardiovascular outcome trial has been conducted with Suliqua.
Forskel i andel versus med lixisenatid [95 % KI]* 
Proportion difference vs. lixisenatide [95% confidence interval]*
Du må ikke bruge pennen, hvis din daglige enkeltdosis er mindre end 10 dosistrin. 
• Do not use the pen if your single daily dose is less than 10 dose steps, shown as white numbers on a black background.
Du må ikke bruge pennen, hvis din daglige enkeltdosis er mindre end 30 dosistrin. 
• Do not use the pen if your single daily dose is less than 30 dose steps, shown as white numbers on a black background.
Hver cylinderampul indeholder 3 ml injektionsvæske. 
Each pen contains 3 ml of solution
Suliqua 100 enheder/ml + 33 mikrogram/ml injektionsvæske, opløsning i en fyldt pen 
Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen INSTRUCTIONS FOR USE
Stempel* Dosisvindue Dosistæller 
Dosage titration
Det kan være tegn på betændelse i bugspytkirtlen 
This could be a sign of of inflamed pancreas (acute pancreatitis).
Den maksimale dosis er 60 dosistrin. 
60 dose steps.
• Du må ikke anvende denne pen, hvis du har brug for en daglig enkeltdosis på under 
• Do not use this pen if you need a single daily dose that is less than 30 dose steps, or more than
EMA/91202/2010 EMEA/H/C/produkt nr. 1055 
EMA/91202/2010 EMEA/H/C/1055
Patienterne blev fulgt i op til et år. 
The patients were followed up for up to a year.
Dette sammendrag blev sidst ajourført i 01-2010. 
This summary was last updated in 04-2010.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ImmunoGam til Cangene Europe Limited den 16. marts 2010. 
The European Commission granted a marketing authorisation valid throughout the EU for ImmunoGam to Cangene Europe Limited on 16 March 2010.
Dette er sammenligneligt med den beskyttelse, der ses ved tilsvarende behandlinger i den publicerede litteratur. 
This is comparable to the protection rate seen with similar treatments in published literature.
ImmunoGam kan anvendes på følgende personer, der har behov for umiddelbar beskyttelse: 
ImmunoGam can be used in the following people, who need immediate protection:
Selv om ImmunoGam ikke selv blev undersøgt i forsøgsmodeller, fremlagde ansøgeren tilstrækkelige data fra undersøgelser af tilsvarende lægemidler. 
Although ImmunoGam itself was not tested in experimental models, the applicant presented adequate data from studies using similar medicines.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for ImmunoGam. 
This document is a summary of the European Public Assessment Report (EPAR) for ImmunoGam.
ImmunoGam er blevet undersøgt i en hovedundersøgelse af 253 nyfødte, hvis mødre var bærere af virusset, og 42 voksne, der potentielt var blevet udsat for virusset. 
ImmunoGam has been investigated in one main study involving 253 newborn babies whose mothers were carriers of the virus and 42 adults who had potentially been exposed to the virus.
Andre oplysninger om ImmunoGam: 
Other information about ImmunoGam:
Af de 178 nyfødte, som gennemførte hovedundersøgelsen, forblev 174 (98 %) fri for hepatitis B-infektion. 
Of the 178 babies who completed the study, 174 (98%) remained free of hepatitis B infection.
Hos disse patienter anvendes det, indtil vaccinen mod virusset virker 
In these patients it is used until vaccination against the virus becomes effective;
På grund af det lille antal voksne, der indgik i undersøgelsen, var vurderingen af lægemidlets fordele hovedsageligt baseret på resultaterne fra de nyfødte. 
Because only a small number of adults were involved in the study, the assessment of the medicine's benefits was based mainly on the results from the babies.
Antistoffer er proteiner i blodet, som hjælper kroppen med at bekæmpe infektioner og andre sygdomme. 
Antibodies are proteins in the blood that help the body to fight infections and other diseases.
Det betyder, at den indeholder de antistoffer, kroppen har brug for for at kunne bekæmpe virus, i stedet for at tilskynde kroppen til at fremstille sine egne antistoffer. 
This means that it supplies the antibodies the body needs to fight the virus rather than stimulating the body to produce its own.
Nyfødte, hvis mødre er bærere af hepatitis B-virus, bør gives 30 til 100 IU/kg ved fødslen eller snarest muligt efter fødslen. 
Newborn babies whose mothers are carriers of the hepatitis B virus should receive 30 to 100 IU/kg at birth or as soon as possible after birth.
Lægemidler, som indeholder specifikke humane hepatitis B-immunglobuliner, har været anvendt i Den Europæiske Union (EU) i mange år. 
Medicines containing human hepatitis B immunoglobulins have been used in the European Union (EU) for many years.
• patienter, der har været i hæmodialyse (en blodrensningsteknik, der anvendes på personer med nyreproblemer). 
• patients who have had haemodialysis (a blood clearance technique used in people with kidney problems).
Personer, der ved et uheld bliver udsat for virusset, skal have mindst 500 internationale enheder (IU) snarest muligt og helst inden for 24 til 72 timer efter at være blevet udsat for virusset. 
People accidentally exposed to the virus should receive at least 500 international units (IU) as soon as possible and preferably within 24 to 72 hours of exposure.
Patienter i hæmodialyse bør gives 8 til 12 IU pr. kg legemsvægt op til et maksimum på 500 IU hver anden måned. 
Haemodialysed patients should received 8 to 12 IU per kilogram body weight up to a maximum of 500 IU, every two months.
ImmunoGam yder "passiv" beskyttelse. 
ImmunoGam provides ‘passive' protection.
Læger bør også tage andre officielle vejledninger i betragtning, når der vælges dosis og doseringsplan for ImmunoGam. 
Doctors should also consider other official guidance when choosing a dose and dosing schedule for ImmunoGam
ImmunoGam gives som injektion i en muskel. 
ImmunoGam is given as an injection into a muscle.
Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for ImmunoGam. 
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ImmunoGam.
De nærmere oplysninger om behandling med ImmunoGam fremgår af indlægssedlen (også en del af EPAR). 
For more information about treatment with ImmunoGam, read the Package Leaflet (also part of the EPAR).
Personer, der er udsat for kontinuerlig risiko for hepatitis B-infektion, og som ikke har udvist en immunrespons efter vaccination, kan gives 500 IU (hos voksne) eller 8 IU/kg (hos børn) hver anden måned. 
Finally, people at continuous risk of hepatitis B infection who did not show an immune response after vaccination may be given 500 IU (in adults) or 8 IU/kg (in children) every two months.
Dette gentages eventuelt, indtil den nyfødte udviser en immunrespons mod virusset efter vaccination. 
This may need to be repeated until the babies show an immune response against the virus after vaccination.
ImmunoGam må ikke anvendes til personer, som kan være hypersensitive (overfølsomme) over for det aktive stof, et eller flere af de øvrige indholdsstoffer eller over for humane immunglobuliner, særlig når de mangler (har meget lave niveauer af) immunglobulin A (IgA) og har antistoffer mod IgA. 
ImmunoGam should not be used in people who may be hypersensitive (allergic) to the active substance, to any of the other ingredients or to human immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Den fuldstændige EPAR for ImmunoGam her. 
The full EPAR for ImmunoGam can be found here.
• personer, som ved et uheld bliver udsat for smitte, og som ikke er fuldt vaccineret 
• people accidentally exposed to the virus who are not known to have been vaccinated fully;
Det primære effektmål var antallet af personer, som forblev frie for hepatitis B-infektion. 
The main measure of effectiveness was the number of people who remained free of hepatitis B infection.
• personer, der har en kontinuerlig risiko for infektion med hepatitis B, og som ikke har udvist immunrespons efter vaccination. 
• people at continuous risk of hepatitis B infection who have not responded to vaccination.
ImmunoGam beskytter mod hepatitis B-virus ved, at koncentrationen af humane hepatitis B-immunglobuliner i blodet holdes på et tilstrækkeligt højt niveau til, at de kan binde sig til virusset og stimulere immunsystemet til at ødelægge det. 
ImmunoGam protects against the hepatitis B virus by keeping the blood levels of human hepatitis B immunoglobulins high enough so that they can attach to the virus and stimulate the immune system to destroy it.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved ImmunoGam opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse for ImmunoGam. 
The Committee for Medicinal Products for Human Use (CHMP) decided that ImmunoGam's benefits are greater than its risks and recommended that it be given marketing authorisation.
Følgende bivirkninger er dog set hos mellem 1 og 10 patienter ud af 1.000: hovedpine, svimmelhed, kvalme, artralgi (ledsmerter), rygsmerter, myalgi 
However, the following side effects are seen in between 1 and 10 patients in 1,000: headache, dizziness, nausea, arthralgia (joint pain), back pain, myalgia (muscle pain), fatigue (tiredness), induration (hardening at the injection site), malaise (feeling unwell), pain at injection site and pyrexia (fever).
Hvilken risiko er der forbundet med ImmunoGam? 
What is the risk associated with ImmunoGam?
Det aktive stof i ImmunoGam, humant hepatitis B-immunglobulin, er et renset antistof udvundet af humant blod. 
The active substance in ImmunoGam, human hepatitis B immunoglobulin, is a purified antibody extracted from human blood.
ImmunoGam humant hepatitis B-immunglobulin 
ImmunoGam human hepatitis B immunoglobulin
Resultaterne hos voksne viste også nogen understøttende evidens for, at ImmunoGam beskytter mod infektion med hepatitis B-virus. 
The results in adults also provided some supportive evidence to show that ImmunoGam protects against hepatitis B virus infection.
Hvorfor blev ImmunoGam godkendt? 
Why has ImmunoGam been approved?
Der ses normalt ikke bivirkninger ved ImmunoGam. 
Side effects with ImmunoGam are not common.
Det anbefales på det kraftigste, at personer, der får ImmunoGam, også gives en hepatitis B-vaccine. 
It is highly recommended that all those receiving ImmunoGam should also be given a hepatitis B vaccine.
Hvad er ImmunoGam? 
What is ImmunoGam?
ImmunoGam anvendes til at yde beskyttelse mod hepatitis B-virus. 
ImmunoGam is used to provide protection against the hepatitis B virus.
Alle dem, der fík ImmunoGam, fik også en hepatitis B-vaccine. 
All those who received ImmunoGam were also given a hepatitis B vaccine.
ImmunoGam er en opløsning til injektion, som indeholder det aktive stof humant hepatitis Bimmunglobolin. 
ImmunoGam is a solution for injection that contains the active substance human hepatitis B immunoglobulin.
• nyfødte, hvor moderen er bærer af hepatitis B-virus 
• newborn babies whose mothers are carriers of the virus;
Hvordan blev ImmunoGam undersøgt? 
How has ImmunoGam been studied?
Hvad anvendes ImmunoGam til? 
What is ImmunoGam used for?
ImmunoGam ydede effektiv beskyttelse mod infektion med hepatitis B-virus. 
ImmunoGam was effective at protecting against hepatitis B virus infection.
Hvilken fordel viser undersøgelserne, at der er ved ImmunoGam? 
What benefit has ImmunoGam shown during the studies?
Hvordan virker ImmunoGam? 
How does ImmunoGam work?
Det betyder, at selv om der ikke foreligger dokumentation fra kliniske undersøgelser, kan det antages, at disse plantelægemidler har en virkning, og der er dokumentation for, at de har været anvendt sikkert på denne måde i mindst 30 år (heraf mindst 15 år i EU). 
This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Diktammerianurt EMA/HMPC/441263/2013 
EMA/HMPC/441263/2013
I sin vurdering tog HMPC hensyn til den veldokumenterede og langvarige anvendelse af diktammerianurt til disse formål. 
In its assessment the HMPC took into account the well documented and longstanding use of dittany of Crete for these conditions.
Mod hudproblemer kan udtrækket anvendes hos personer over 12 år i højst to uger; hvis symptomerne vedvarer, bør der søges lægehjælp. 
When used for skin problems the infusion may be used in those above the age of 12 years for up to two weeks; if symptoms last longer than this, advice should be sought from a qualified healthcare practitioner.
Ansøgninger om godkendelse af lægemidler, der indeholder diktammerianurt, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner. 
Any applications for the licensing of medicines containing dittany of Crete herb have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.